65 simpozijum farmaceutskih udruženja srbije
TRANSCRIPT
Racionalna primena lekova u trudnoći
i tokom dojenja
(primeri i iskustvo iz prakse)
Diplfarmspec Jasna Urošević
Ciljevi
Lakše prepoznavanje i preporuka za izbegavanje upotrebe
lekova sa rizikom za plod bilo da su oni propisani na
recept ili se mogu kupiti bez recepta
Razvoj strukturisanog pristupa adekvatnoj proceni
bezbednosti propisane terapije u populaciji trudnica I
dojilja kao i razvoj savetovanja određenih mera kod
lakših zdravstvenih problema
Razvoj komunikacije pri izdavanju lekova I OTC preparata
na nivou nefarmakoloških preporuka i saveta kao i na
nivou doziranja i odabira odgovarajućeg leka I OTC
preparata
Upoznavanje sa odgovarajućim aktuelnim izvorima
informacija o upotrebi lekova u ovoj populaciji
Slučaj br 1
Pacijentkinja TP ( 31godina ) dolazi u apoteku zbog problema sa mokrenjem koji traju poslednjih
24 časa bol u donjem delu stomaka učestalo mokrenje malih količina urina i urgentnost
Pacijentkinja nema temperaturu
Poslednji redovni pregled urina u Domu zdravlja imala je pre dve nedelje pri čemu je nalaz bio
uredan
Pacijentkinja navodi da je u 7 nedelji trudnoće i da je pre začeća imala povremene ˝upale
bešike˝
Moli Vas za savet da li može da popije fosfomicin-trometamol 3 g uveče pre spavanja dok ne
poseti izabranog ginekologa da bi ublažila simptome jer joj je kod ranijih ˝upala bešike˝ pre
trudnoće lek pomagao takođe zanima je da li može da koristi nešto od čajeva (čaj od peršuna ili
uvin čaj ili čaj od brusnice)
Fosfomicinu
trudnoći
Čaj od brusnice u trudnoći
Uvin čaj u trudnoći
Čaj od peršuna u trudnoći
Korisni izvori dokaza koji se mogu koristiti za klasifikaciju rizika
od primene leka tokom trudnoće I dojenja Barlow SM Sullivan FM Reproductive Hazards of Industrial Chemicals London Academic Press
1982
Briggs GG Freeman RK Drugs in Pregnancy and Lactation A Reference Guide to Fetal and Neonatal Risk 10th ed Philadelphia Pa Wolters Kluwer Health 2015
Folb PI Graham Dukes MN (eds) Drug Safety in Pregnancy Amsterdam Elsevier Science Publishers BV 1990
Friedman JM Polifka JE Effects of Drugs on the Fetus and Nursing Infant A Handbook for Health Care Professionals Baltimore Md The Johns Hopkins University Press 1996
Gilstrap LC III Little BB Drugs and Pregnancy 2nd ed New York Elsevier 1998
Koren G Maternal-Fetal Toxicology A Clinicianrsquos Guide 3rd ed New York Marcel Dekker 2001
Paul M Occupational and Environmental Reproductive Hazards A Guide for Clinicians Baltimore Md Williams amp Wilkins 1993
Schaefer C Peters P Miller RK (eds) Drugs During Pregnancy and Lactation Treatment Options and Risk Assessment 3rd ed Waltham Mass Academic Press 2015
Schardein JL Chemically Induced Birth Defects 2nd ed New York Marcel Dekker 1993
Scialli AR Lione A Boyle Padgett GK Reproductive Effects of Chemical Physical and Biologic Agents Baltimore Md The Johns Hopkins University Press 1995
Shepard TH Catalog of Teratogenic Agents 13th ed Baltimore Md The Johns Hopkins University Press 2010
Hale W Thomas PhD Medications and Motherrsquos Milk 15th Edition 2012
Referenca Zemlja Komentar
Agencija za lekove i medicinska sredstva Srbije
wwwalimsgovrs
Srbija Sadrži prikaz lekova registrovanih u Srbiji
European Medicines Agency
wwwemaeuropaeu
EU Sadrži ˝European public assessment reports (EPAR) ˝za humane
biljne i veterinarske lekove
MotherToBabyhttpswwwmothertobabyorg
httpwwwmothertobabyorgfact-sheets-s13037
( Sadrži informacije za pacijente )
SADKanada
Organization of
Teratology
Information
Specialists
Ne sadrži informacije za sve lekove
Motheriskhttp wwwmotheriskorg
httpwwwmotheriskorgwomendrugsjsp
(Informacije o lekovima i OTC preparatima)
httpwwwmotheriskorgwomenmothernaturejsp
( Informacije o herbalnim proizvodima)
Kanada University of
Toronto The
Hospital for Sick
Children Motherisk
Program
Ne sadrži informacije za sve lekove
Sadrži samo linkove za studije sprovedene od strane tima Motherisk
programa
Perinatal Psychotropic Medication Information Service (PPMIS)
Royal Womenrsquos Hospital Victoria
wwwppmisorgauAustralija
Informacije za pacijente
Informacije samo o psihotropnim lekovima
Prescribing medicines in pregnancy database httpwwwtgagovauhpmedicinespregnancyhtm Australija
Kratke i ključne informacije za neke lekove
Uključuje reference vezene za Australijsku kategorizaciju lekova
LactMedhttpstoxnetnlmnihgovnewtoxnetlactmedhtm
SAD Sadrži redovno ažurirane podatke o upotrebi lekova i OTC
preparata isključivo tokom dojenja
US Food and Drug AdministrationhttpwwwfdagovForConsumersByAudienceForWomenWomensHealthTop
icsucm117976htmMedicine_and_Pregnancy (Informacije za pacijente)
National Library of Medicinehttpdailymednlmnihgovdailymedaboutcfm (Informacije za pacijente i
stručnu javnost )
SAD Nema redovnog ažuriranja podataka
Besplatni
On-line
izvori
dokaza
korisni u
radnoj
praksi
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Ciljevi
Lakše prepoznavanje i preporuka za izbegavanje upotrebe
lekova sa rizikom za plod bilo da su oni propisani na
recept ili se mogu kupiti bez recepta
Razvoj strukturisanog pristupa adekvatnoj proceni
bezbednosti propisane terapije u populaciji trudnica I
dojilja kao i razvoj savetovanja određenih mera kod
lakših zdravstvenih problema
Razvoj komunikacije pri izdavanju lekova I OTC preparata
na nivou nefarmakoloških preporuka i saveta kao i na
nivou doziranja i odabira odgovarajućeg leka I OTC
preparata
Upoznavanje sa odgovarajućim aktuelnim izvorima
informacija o upotrebi lekova u ovoj populaciji
Slučaj br 1
Pacijentkinja TP ( 31godina ) dolazi u apoteku zbog problema sa mokrenjem koji traju poslednjih
24 časa bol u donjem delu stomaka učestalo mokrenje malih količina urina i urgentnost
Pacijentkinja nema temperaturu
Poslednji redovni pregled urina u Domu zdravlja imala je pre dve nedelje pri čemu je nalaz bio
uredan
Pacijentkinja navodi da je u 7 nedelji trudnoće i da je pre začeća imala povremene ˝upale
bešike˝
Moli Vas za savet da li može da popije fosfomicin-trometamol 3 g uveče pre spavanja dok ne
poseti izabranog ginekologa da bi ublažila simptome jer joj je kod ranijih ˝upala bešike˝ pre
trudnoće lek pomagao takođe zanima je da li može da koristi nešto od čajeva (čaj od peršuna ili
uvin čaj ili čaj od brusnice)
Fosfomicinu
trudnoći
Čaj od brusnice u trudnoći
Uvin čaj u trudnoći
Čaj od peršuna u trudnoći
Korisni izvori dokaza koji se mogu koristiti za klasifikaciju rizika
od primene leka tokom trudnoće I dojenja Barlow SM Sullivan FM Reproductive Hazards of Industrial Chemicals London Academic Press
1982
Briggs GG Freeman RK Drugs in Pregnancy and Lactation A Reference Guide to Fetal and Neonatal Risk 10th ed Philadelphia Pa Wolters Kluwer Health 2015
Folb PI Graham Dukes MN (eds) Drug Safety in Pregnancy Amsterdam Elsevier Science Publishers BV 1990
Friedman JM Polifka JE Effects of Drugs on the Fetus and Nursing Infant A Handbook for Health Care Professionals Baltimore Md The Johns Hopkins University Press 1996
Gilstrap LC III Little BB Drugs and Pregnancy 2nd ed New York Elsevier 1998
Koren G Maternal-Fetal Toxicology A Clinicianrsquos Guide 3rd ed New York Marcel Dekker 2001
Paul M Occupational and Environmental Reproductive Hazards A Guide for Clinicians Baltimore Md Williams amp Wilkins 1993
Schaefer C Peters P Miller RK (eds) Drugs During Pregnancy and Lactation Treatment Options and Risk Assessment 3rd ed Waltham Mass Academic Press 2015
Schardein JL Chemically Induced Birth Defects 2nd ed New York Marcel Dekker 1993
Scialli AR Lione A Boyle Padgett GK Reproductive Effects of Chemical Physical and Biologic Agents Baltimore Md The Johns Hopkins University Press 1995
Shepard TH Catalog of Teratogenic Agents 13th ed Baltimore Md The Johns Hopkins University Press 2010
Hale W Thomas PhD Medications and Motherrsquos Milk 15th Edition 2012
Referenca Zemlja Komentar
Agencija za lekove i medicinska sredstva Srbije
wwwalimsgovrs
Srbija Sadrži prikaz lekova registrovanih u Srbiji
European Medicines Agency
wwwemaeuropaeu
EU Sadrži ˝European public assessment reports (EPAR) ˝za humane
biljne i veterinarske lekove
MotherToBabyhttpswwwmothertobabyorg
httpwwwmothertobabyorgfact-sheets-s13037
( Sadrži informacije za pacijente )
SADKanada
Organization of
Teratology
Information
Specialists
Ne sadrži informacije za sve lekove
Motheriskhttp wwwmotheriskorg
httpwwwmotheriskorgwomendrugsjsp
(Informacije o lekovima i OTC preparatima)
httpwwwmotheriskorgwomenmothernaturejsp
( Informacije o herbalnim proizvodima)
Kanada University of
Toronto The
Hospital for Sick
Children Motherisk
Program
Ne sadrži informacije za sve lekove
Sadrži samo linkove za studije sprovedene od strane tima Motherisk
programa
Perinatal Psychotropic Medication Information Service (PPMIS)
Royal Womenrsquos Hospital Victoria
wwwppmisorgauAustralija
Informacije za pacijente
Informacije samo o psihotropnim lekovima
Prescribing medicines in pregnancy database httpwwwtgagovauhpmedicinespregnancyhtm Australija
Kratke i ključne informacije za neke lekove
Uključuje reference vezene za Australijsku kategorizaciju lekova
LactMedhttpstoxnetnlmnihgovnewtoxnetlactmedhtm
SAD Sadrži redovno ažurirane podatke o upotrebi lekova i OTC
preparata isključivo tokom dojenja
US Food and Drug AdministrationhttpwwwfdagovForConsumersByAudienceForWomenWomensHealthTop
icsucm117976htmMedicine_and_Pregnancy (Informacije za pacijente)
National Library of Medicinehttpdailymednlmnihgovdailymedaboutcfm (Informacije za pacijente i
stručnu javnost )
SAD Nema redovnog ažuriranja podataka
Besplatni
On-line
izvori
dokaza
korisni u
radnoj
praksi
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Slučaj br 1
Pacijentkinja TP ( 31godina ) dolazi u apoteku zbog problema sa mokrenjem koji traju poslednjih
24 časa bol u donjem delu stomaka učestalo mokrenje malih količina urina i urgentnost
Pacijentkinja nema temperaturu
Poslednji redovni pregled urina u Domu zdravlja imala je pre dve nedelje pri čemu je nalaz bio
uredan
Pacijentkinja navodi da je u 7 nedelji trudnoće i da je pre začeća imala povremene ˝upale
bešike˝
Moli Vas za savet da li može da popije fosfomicin-trometamol 3 g uveče pre spavanja dok ne
poseti izabranog ginekologa da bi ublažila simptome jer joj je kod ranijih ˝upala bešike˝ pre
trudnoće lek pomagao takođe zanima je da li može da koristi nešto od čajeva (čaj od peršuna ili
uvin čaj ili čaj od brusnice)
Fosfomicinu
trudnoći
Čaj od brusnice u trudnoći
Uvin čaj u trudnoći
Čaj od peršuna u trudnoći
Korisni izvori dokaza koji se mogu koristiti za klasifikaciju rizika
od primene leka tokom trudnoće I dojenja Barlow SM Sullivan FM Reproductive Hazards of Industrial Chemicals London Academic Press
1982
Briggs GG Freeman RK Drugs in Pregnancy and Lactation A Reference Guide to Fetal and Neonatal Risk 10th ed Philadelphia Pa Wolters Kluwer Health 2015
Folb PI Graham Dukes MN (eds) Drug Safety in Pregnancy Amsterdam Elsevier Science Publishers BV 1990
Friedman JM Polifka JE Effects of Drugs on the Fetus and Nursing Infant A Handbook for Health Care Professionals Baltimore Md The Johns Hopkins University Press 1996
Gilstrap LC III Little BB Drugs and Pregnancy 2nd ed New York Elsevier 1998
Koren G Maternal-Fetal Toxicology A Clinicianrsquos Guide 3rd ed New York Marcel Dekker 2001
Paul M Occupational and Environmental Reproductive Hazards A Guide for Clinicians Baltimore Md Williams amp Wilkins 1993
Schaefer C Peters P Miller RK (eds) Drugs During Pregnancy and Lactation Treatment Options and Risk Assessment 3rd ed Waltham Mass Academic Press 2015
Schardein JL Chemically Induced Birth Defects 2nd ed New York Marcel Dekker 1993
Scialli AR Lione A Boyle Padgett GK Reproductive Effects of Chemical Physical and Biologic Agents Baltimore Md The Johns Hopkins University Press 1995
Shepard TH Catalog of Teratogenic Agents 13th ed Baltimore Md The Johns Hopkins University Press 2010
Hale W Thomas PhD Medications and Motherrsquos Milk 15th Edition 2012
Referenca Zemlja Komentar
Agencija za lekove i medicinska sredstva Srbije
wwwalimsgovrs
Srbija Sadrži prikaz lekova registrovanih u Srbiji
European Medicines Agency
wwwemaeuropaeu
EU Sadrži ˝European public assessment reports (EPAR) ˝za humane
biljne i veterinarske lekove
MotherToBabyhttpswwwmothertobabyorg
httpwwwmothertobabyorgfact-sheets-s13037
( Sadrži informacije za pacijente )
SADKanada
Organization of
Teratology
Information
Specialists
Ne sadrži informacije za sve lekove
Motheriskhttp wwwmotheriskorg
httpwwwmotheriskorgwomendrugsjsp
(Informacije o lekovima i OTC preparatima)
httpwwwmotheriskorgwomenmothernaturejsp
( Informacije o herbalnim proizvodima)
Kanada University of
Toronto The
Hospital for Sick
Children Motherisk
Program
Ne sadrži informacije za sve lekove
Sadrži samo linkove za studije sprovedene od strane tima Motherisk
programa
Perinatal Psychotropic Medication Information Service (PPMIS)
Royal Womenrsquos Hospital Victoria
wwwppmisorgauAustralija
Informacije za pacijente
Informacije samo o psihotropnim lekovima
Prescribing medicines in pregnancy database httpwwwtgagovauhpmedicinespregnancyhtm Australija
Kratke i ključne informacije za neke lekove
Uključuje reference vezene za Australijsku kategorizaciju lekova
LactMedhttpstoxnetnlmnihgovnewtoxnetlactmedhtm
SAD Sadrži redovno ažurirane podatke o upotrebi lekova i OTC
preparata isključivo tokom dojenja
US Food and Drug AdministrationhttpwwwfdagovForConsumersByAudienceForWomenWomensHealthTop
icsucm117976htmMedicine_and_Pregnancy (Informacije za pacijente)
National Library of Medicinehttpdailymednlmnihgovdailymedaboutcfm (Informacije za pacijente i
stručnu javnost )
SAD Nema redovnog ažuriranja podataka
Besplatni
On-line
izvori
dokaza
korisni u
radnoj
praksi
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Fosfomicinu
trudnoći
Čaj od brusnice u trudnoći
Uvin čaj u trudnoći
Čaj od peršuna u trudnoći
Korisni izvori dokaza koji se mogu koristiti za klasifikaciju rizika
od primene leka tokom trudnoće I dojenja Barlow SM Sullivan FM Reproductive Hazards of Industrial Chemicals London Academic Press
1982
Briggs GG Freeman RK Drugs in Pregnancy and Lactation A Reference Guide to Fetal and Neonatal Risk 10th ed Philadelphia Pa Wolters Kluwer Health 2015
Folb PI Graham Dukes MN (eds) Drug Safety in Pregnancy Amsterdam Elsevier Science Publishers BV 1990
Friedman JM Polifka JE Effects of Drugs on the Fetus and Nursing Infant A Handbook for Health Care Professionals Baltimore Md The Johns Hopkins University Press 1996
Gilstrap LC III Little BB Drugs and Pregnancy 2nd ed New York Elsevier 1998
Koren G Maternal-Fetal Toxicology A Clinicianrsquos Guide 3rd ed New York Marcel Dekker 2001
Paul M Occupational and Environmental Reproductive Hazards A Guide for Clinicians Baltimore Md Williams amp Wilkins 1993
Schaefer C Peters P Miller RK (eds) Drugs During Pregnancy and Lactation Treatment Options and Risk Assessment 3rd ed Waltham Mass Academic Press 2015
Schardein JL Chemically Induced Birth Defects 2nd ed New York Marcel Dekker 1993
Scialli AR Lione A Boyle Padgett GK Reproductive Effects of Chemical Physical and Biologic Agents Baltimore Md The Johns Hopkins University Press 1995
Shepard TH Catalog of Teratogenic Agents 13th ed Baltimore Md The Johns Hopkins University Press 2010
Hale W Thomas PhD Medications and Motherrsquos Milk 15th Edition 2012
Referenca Zemlja Komentar
Agencija za lekove i medicinska sredstva Srbije
wwwalimsgovrs
Srbija Sadrži prikaz lekova registrovanih u Srbiji
European Medicines Agency
wwwemaeuropaeu
EU Sadrži ˝European public assessment reports (EPAR) ˝za humane
biljne i veterinarske lekove
MotherToBabyhttpswwwmothertobabyorg
httpwwwmothertobabyorgfact-sheets-s13037
( Sadrži informacije za pacijente )
SADKanada
Organization of
Teratology
Information
Specialists
Ne sadrži informacije za sve lekove
Motheriskhttp wwwmotheriskorg
httpwwwmotheriskorgwomendrugsjsp
(Informacije o lekovima i OTC preparatima)
httpwwwmotheriskorgwomenmothernaturejsp
( Informacije o herbalnim proizvodima)
Kanada University of
Toronto The
Hospital for Sick
Children Motherisk
Program
Ne sadrži informacije za sve lekove
Sadrži samo linkove za studije sprovedene od strane tima Motherisk
programa
Perinatal Psychotropic Medication Information Service (PPMIS)
Royal Womenrsquos Hospital Victoria
wwwppmisorgauAustralija
Informacije za pacijente
Informacije samo o psihotropnim lekovima
Prescribing medicines in pregnancy database httpwwwtgagovauhpmedicinespregnancyhtm Australija
Kratke i ključne informacije za neke lekove
Uključuje reference vezene za Australijsku kategorizaciju lekova
LactMedhttpstoxnetnlmnihgovnewtoxnetlactmedhtm
SAD Sadrži redovno ažurirane podatke o upotrebi lekova i OTC
preparata isključivo tokom dojenja
US Food and Drug AdministrationhttpwwwfdagovForConsumersByAudienceForWomenWomensHealthTop
icsucm117976htmMedicine_and_Pregnancy (Informacije za pacijente)
National Library of Medicinehttpdailymednlmnihgovdailymedaboutcfm (Informacije za pacijente i
stručnu javnost )
SAD Nema redovnog ažuriranja podataka
Besplatni
On-line
izvori
dokaza
korisni u
radnoj
praksi
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Korisni izvori dokaza koji se mogu koristiti za klasifikaciju rizika
od primene leka tokom trudnoće I dojenja Barlow SM Sullivan FM Reproductive Hazards of Industrial Chemicals London Academic Press
1982
Briggs GG Freeman RK Drugs in Pregnancy and Lactation A Reference Guide to Fetal and Neonatal Risk 10th ed Philadelphia Pa Wolters Kluwer Health 2015
Folb PI Graham Dukes MN (eds) Drug Safety in Pregnancy Amsterdam Elsevier Science Publishers BV 1990
Friedman JM Polifka JE Effects of Drugs on the Fetus and Nursing Infant A Handbook for Health Care Professionals Baltimore Md The Johns Hopkins University Press 1996
Gilstrap LC III Little BB Drugs and Pregnancy 2nd ed New York Elsevier 1998
Koren G Maternal-Fetal Toxicology A Clinicianrsquos Guide 3rd ed New York Marcel Dekker 2001
Paul M Occupational and Environmental Reproductive Hazards A Guide for Clinicians Baltimore Md Williams amp Wilkins 1993
Schaefer C Peters P Miller RK (eds) Drugs During Pregnancy and Lactation Treatment Options and Risk Assessment 3rd ed Waltham Mass Academic Press 2015
Schardein JL Chemically Induced Birth Defects 2nd ed New York Marcel Dekker 1993
Scialli AR Lione A Boyle Padgett GK Reproductive Effects of Chemical Physical and Biologic Agents Baltimore Md The Johns Hopkins University Press 1995
Shepard TH Catalog of Teratogenic Agents 13th ed Baltimore Md The Johns Hopkins University Press 2010
Hale W Thomas PhD Medications and Motherrsquos Milk 15th Edition 2012
Referenca Zemlja Komentar
Agencija za lekove i medicinska sredstva Srbije
wwwalimsgovrs
Srbija Sadrži prikaz lekova registrovanih u Srbiji
European Medicines Agency
wwwemaeuropaeu
EU Sadrži ˝European public assessment reports (EPAR) ˝za humane
biljne i veterinarske lekove
MotherToBabyhttpswwwmothertobabyorg
httpwwwmothertobabyorgfact-sheets-s13037
( Sadrži informacije za pacijente )
SADKanada
Organization of
Teratology
Information
Specialists
Ne sadrži informacije za sve lekove
Motheriskhttp wwwmotheriskorg
httpwwwmotheriskorgwomendrugsjsp
(Informacije o lekovima i OTC preparatima)
httpwwwmotheriskorgwomenmothernaturejsp
( Informacije o herbalnim proizvodima)
Kanada University of
Toronto The
Hospital for Sick
Children Motherisk
Program
Ne sadrži informacije za sve lekove
Sadrži samo linkove za studije sprovedene od strane tima Motherisk
programa
Perinatal Psychotropic Medication Information Service (PPMIS)
Royal Womenrsquos Hospital Victoria
wwwppmisorgauAustralija
Informacije za pacijente
Informacije samo o psihotropnim lekovima
Prescribing medicines in pregnancy database httpwwwtgagovauhpmedicinespregnancyhtm Australija
Kratke i ključne informacije za neke lekove
Uključuje reference vezene za Australijsku kategorizaciju lekova
LactMedhttpstoxnetnlmnihgovnewtoxnetlactmedhtm
SAD Sadrži redovno ažurirane podatke o upotrebi lekova i OTC
preparata isključivo tokom dojenja
US Food and Drug AdministrationhttpwwwfdagovForConsumersByAudienceForWomenWomensHealthTop
icsucm117976htmMedicine_and_Pregnancy (Informacije za pacijente)
National Library of Medicinehttpdailymednlmnihgovdailymedaboutcfm (Informacije za pacijente i
stručnu javnost )
SAD Nema redovnog ažuriranja podataka
Besplatni
On-line
izvori
dokaza
korisni u
radnoj
praksi
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Referenca Zemlja Komentar
Agencija za lekove i medicinska sredstva Srbije
wwwalimsgovrs
Srbija Sadrži prikaz lekova registrovanih u Srbiji
European Medicines Agency
wwwemaeuropaeu
EU Sadrži ˝European public assessment reports (EPAR) ˝za humane
biljne i veterinarske lekove
MotherToBabyhttpswwwmothertobabyorg
httpwwwmothertobabyorgfact-sheets-s13037
( Sadrži informacije za pacijente )
SADKanada
Organization of
Teratology
Information
Specialists
Ne sadrži informacije za sve lekove
Motheriskhttp wwwmotheriskorg
httpwwwmotheriskorgwomendrugsjsp
(Informacije o lekovima i OTC preparatima)
httpwwwmotheriskorgwomenmothernaturejsp
( Informacije o herbalnim proizvodima)
Kanada University of
Toronto The
Hospital for Sick
Children Motherisk
Program
Ne sadrži informacije za sve lekove
Sadrži samo linkove za studije sprovedene od strane tima Motherisk
programa
Perinatal Psychotropic Medication Information Service (PPMIS)
Royal Womenrsquos Hospital Victoria
wwwppmisorgauAustralija
Informacije za pacijente
Informacije samo o psihotropnim lekovima
Prescribing medicines in pregnancy database httpwwwtgagovauhpmedicinespregnancyhtm Australija
Kratke i ključne informacije za neke lekove
Uključuje reference vezene za Australijsku kategorizaciju lekova
LactMedhttpstoxnetnlmnihgovnewtoxnetlactmedhtm
SAD Sadrži redovno ažurirane podatke o upotrebi lekova i OTC
preparata isključivo tokom dojenja
US Food and Drug AdministrationhttpwwwfdagovForConsumersByAudienceForWomenWomensHealthTop
icsucm117976htmMedicine_and_Pregnancy (Informacije za pacijente)
National Library of Medicinehttpdailymednlmnihgovdailymedaboutcfm (Informacije za pacijente i
stručnu javnost )
SAD Nema redovnog ažuriranja podataka
Besplatni
On-line
izvori
dokaza
korisni u
radnoj
praksi
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Agencija za lekove i medicinska sredstva Srbije (ALIMS)1
Nije poznato da li se fosfomicin i njegovi metaboliti izlučuju u majčino mleko pa se ni rizik
po novorođenče ne može isključiti
Za vreme trudnoće i dojenja ovaj lek bi trebalo primenjivati samo ukoliko je neophodno i
uvek pod neposrednim nadzorom lekara
1httpwwwalimsgovrscirilfileslekovipil515-01-9103-11-001pdf
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Treatment of bacteriuria in pregnancy with single dose
fosfomycin trometamol a review Reeves DS Infection 199220 Suppl 4S313-6
Abstract
Bacteriuria in pregnancy occurs in about one in 20 pregnant women and is usually initially asymptomatic
It is an important marker for acute symptomatic infection (often pyelonephritis) later in pregnancy which
occurs in about one in four bacteriurics Several considerations surround the antibiotic treatment of
the asymptomatic infection these include a low frequency of in vitro resistance to the agent used
lack of toxicity to the foetus a low incidence of gastrointestinal side effects good compliance and
proven efficacy Fosfomycin trometamol seems to fit these requirements In three controlled
studies (two multicentric) 250 patients were treated with fosfomycin trometamol in a 3 g (as
fosfomycin) single dose 197 patients were given one of three other agents Cure rates for
fosfomycin trometamol were 77-94 (68-94 for other agents) which was satisfactory in an
infection which is sometimes difficult to eradicate Further studies are needed in this important but
accessible group of patients Opportunities should be taken to study more foetal outcomes and provide
more data on gastro-intestinal tolerability
httpwwwncbinlmnihgovpubmed1294525
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Fosfomycin trometamol a review of its use as a single-dose oral treatment for patients
with acute lower urinary tract infections and pregnant women with asymptomatic
bacteriuria
Keating GM Drugs 2013 Nov73(17)1951-66 doi 101007s40265-013-0143-y
Abstract
Fosfomycin trometamol (fosfomycin tromethamine) [Monuril(reg) Monurol(reg) Monural(reg)] is approved in numerous countries
worldwide mainly for the treatment of uncomplicated urinary tract infections (UTIs) Fosfomycin has good in vitro activity against
common uropathogens such as Escherichia coli (including extended-spectrum β-lactamase-producing E coli) Proteus mirabilis
Klebsiella pneumoniae and Staphylococcus saprophyticus and the susceptibility of uropathogens to fosfomycin has remained
relatively stable over time A single oral dose of fosfomycin trometamol 3 g (the approved dosage) achieves high concentrations
in urine Results of recent randomized trials indicate that single-dose fosfomycin trometamol had similar clinical andor
bacteriological efficacy to 3- to 7-day regimens of ciprofloxacin norfloxacin cotrimoxazole or nitrofurantoin in women
with uncomplicated lower UTIs In addition single-dose fosfomycin trometamol had similar bacteriological efficacy to a
5-day course of cefuroxime axetil or a 7-day course of amoxicillinclavulanic acid in pregnant women with
asymptomatic bacteriuria and similar clinical andor bacteriological efficacy to a 5-day course of cefuroxime axetil or
amoxicillinclavulanic acid or a 3-day course of ceftibuten in pregnant women with a lower UTI Single-dose fosfomycin
trometamol was generally well tolerated with gastrointestinal adverse events (eg diarrhoea nausea) reported most
commonly In conclusion single-dose fosfomycin trometamol is an important option for the first-line
empiricaltreatment of uncomplicated lower UTIs
httpwwwncbinlmnihgovpubmed24202878
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
US Food and Drug Administration
Pregnancy
Teratogenic Effects
Pregnancy Category B
When administered intramuscularly as the sodium salt at a dose of 1 gm to pregnant women fosfomycin crosses the
placental barrier MONUROL crosses the placental barrier of rats it does not produce teratogenic effects in pregnant rats
at dosages as high as 1000 mgkgday (approximately 9 and 14 times the human dose based on body weight and
mgm2 respectively) When administered to pregnant female rabbits at dosages as high as 1000 mgkgday
(approximately 9 and 27 times the human dose based on body weight and mgm2 respectively) fetotoxicities were
observed However these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity
of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration There are however no
adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive
of human response this drug should be used during pregnancy only if clearly needed
httpwwwaccessdatafdagovdrugsatfda_docslabel2008050717s005lblpdf
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Safety and efficacy of cranberry (vaccinium macrocarpon) during
pregnancy and lactation1
Dugoua JJ Seely D Perri D Mills E Koren GCan J Clin Pharmacol 2008 Winter15(1)e80-6 Epub 2008 Jan 18
Abstract
BACKGROUNDThere is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbs
used during pregnancy and lactation This is one article in a series that systematically reviews the evidence for herbs commonly used during
pregnancy and lactation
OBJECTIVESTo systematically review the literature for evidence on the use safety and pharmacology of cranberry focusing on issues
pertaining to pregnancy and lactation
METHODSWe searched 7 electronic databases and compiled data according to the grade of evidence found
RESULTSThere is no direct evidence of safety or harm to the mother or fetus as a result of consuming cranberry during pregnancy
Indirectly there is good scientific evidence that cranberry may be of minimal risk where a survey of 400 pregnant women did not
uncover any adverse events when cranberry was regularly consumed In lactation the safety or harm of cranberry is unknown
CONCLUSIONSWomen experience urinary tract infections with greater frequency during pregnancy Given the evidence to support
the use of cranberry for urinary tract infections (UTIs) and its safety profile cranberry supplementation as fruit or fruit juice may be
a valuable therapeutic choice in the treatment of UTIs during pregnancy
1 httpwwwncbinlmnihgovpubmed18204103
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Daily cranberry juice for the prevention of asymptomatic
bacteriuria in pregnancy a randomized controlled pilot study 1
Wing DA Rumney PJ Preslicka CW Chung JH J Urol 2008 180(4)1367-72 (ISSN 1527-3792)
PURPOSE We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria
and symptomatic urinary tract infections
MATERIALS AND METHODS A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times
daily (58) B-cranberry at breakfast then placebo at lunch and dinner (67) and C-placebo 3 times daily (63) After 277 (52 of 188) of the
subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance
RESULTS There were 27 urinary tract infections in 18 subjects in this cohort with 6 in 4 group A subjects 10 in 7 group B subjects and 11 in 7 group
C subjects (p = 071) There was a 57 and 41 reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections
respectively in the multiple daily dosing group However this study was not sufficiently powered at the alpha 005 level (CI 014-139 and
022-160 respectively incidence rate ratios) Of 188 subjects 73 (388) withdrew most for gastrointestinal upset
CONCLUSIONS These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and
symptomatic urinary tract infections in pregnancy Further studies are planned to evaluate this effect
1 httpreferencemedscapecommedlineabstract18707726
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
httpbuecherheilpflanzen-weltde
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Edukacija pacijenta o merama za prevenciju nastanka IUT u
trudnoći1
Unositi 6-8 čaša vode na dan i nezaslađen sok od brusnice redovno
Eliminisati rafinisane namirnice voćne sokove kofein alkohol i šećer I ishrani
Uzimati Vitamin C (250 do 500 mg dnevno) beta-karoten (25000 do 50000 IU dnevno) i cink
(30-50 mg dnevno)
Razviti naviku mokrenje čim se potreba oseća i pri tome potpuno isprazniti bešiku
Mokrenj pre i posle odnosa
Izbegavanje odnosa dok se lečite od IUT
Nakon mokrenje preporučuje se brisanje genitalne regije od prednje ka zadnjoj strani
Izbegavajte korišćenje jakih sapuna tuševa krema koje sadrže antiseptike higijenske sprejeve
i praškove
Menjati donji veš i čarape (pamuk ) svaki dan
Izbegavanje nošenja uske odeće
Ne boraviti u kadi duže od 30 minuta više od dva puta dnevno
1httpamericanpregnancyorgpregnancy-complicationsurinary-tract-infections-during-pregnancy
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Fosfomicin I čaj od brusnice u trudnoći DA
Čaj od peršuna i uvin čaj u trudnoćiNE
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Slučaj br2
Pacijentkinja MNpeta nedelja trudnoće stara 34 godine boluje od astme ialergijskog rinitisa
Poslednjih dana ima intezivniji kašalj stezanje u grudima kijanje ˝svrab i dosta curenja iz nosa vodenog sekreta˝
Moli Vas da joj preporučite nešto od kapi za nos napominje da joj je kod ovakvih simptoma ranije pomagao loratadin 10 mg ali ga ne koristi jer smatra da će naškoditi trudnoći kao i da je ˝smanjila˝ upotrebu svoje redovne terapije za astmu i alergijski rinitisjer je pročitala na internetu da u prva tri meseca ne bi trebalo da se koristi ništa od lekova jer mogu naškoditi bebi ali kasnije ako joj budu potrebni ponovo će ih koristiti
Terapija
montelukast 10 mg dnevno
mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacija dva puta dnevno
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Kapi za nos
Loratadin 10 mg dnevno
Montelukast 10 mg dnevno
Mometazon 005 sprej za nos dve aplikacije u svaku nozdrvu jednom dnevno
Salmeterolflutikazon prašak za inhalaciju (diskus) 50 mikrogramadoza + 250 mikrogramadoza - jedna inhalacijadva puta dnevno
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Treating Asthma and Comorbid Allergic Rhinitis in Pregnancy1
hellipDecongestants do not improve nasal itching sneezing or rhinorrhea but they are very effective against nasal
obstruction[2943] Short-term use of intranasal decongestants such as oxymetazoline (Pregnancy Category C) can
be helpful for nasal congestion that interferes with sleep but pregnant women should reserve their use until
after the first trimester and avoid them during labor (SOR-B)[24] Some experts recommend completely avoiding
intranasal decongestants during pregnancy even after the first trimester due to the lack of sufficient human data
(SOR-B)[25]
ARIA advises that due to the risk of rhinitis medicamentosa intranasal decongestants should not be used (even
by nonpregnant patients) for more than 9 days[31] Pregnant women often favor topical over-the-counter
medications over prescription medications believing them to be safer[24]Physicians should specifically ask about
the duration of self-treatment with nasal sprays and explain the risks[50]
Case-control studies have linked first-trimester use of pseudoephedrine[5152] (Pregnancy Category C) and
phenylpropanolamine[51] (recently withdrawn from the US market) with gastroschisis (an abdominal wall defect in
which the intestines protrude outside the fetus)[5152] For this reason ACOG-ACAAI recommends avoiding oral
decongestants during the first trimester unless a compelling benefit is expected (SOR-B)[39] ARIA suggests avoiding
pseudoephedrine during pregnancy and using other decongestants with caution (SOR-B)[29] APWG notes that if a
nasal decongestant is indicated in early pregnancy an external nasal dilator strip short-term topical oxymetazoline or an
INS can be considered before an oral decongestant[1] Physicians should caution pregnant patients that many over-
the-counter cold and allergy remedies contain pseudoephedrine
1Yawn B Knudtson M Treating Asthma and Comorbid Allergic Rhinitis in PregnancyJ Am Board Fam Med 2007 May-Jun20(3)289-98 dostupno na
httpwwwjabfmorgcontent203289fullpdf
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Treatment of allergic rhinitis during pregnancy1
Keleş N1 Am J Rhinol 2004 Jan-Feb18(1)23-8
Abstract
BACKGROUND
Allergic rhinitis (AR) affecting approximately 20-30 of women in childbearing age can be considered one of the most
common group of medical conditions that complicate pregnancy AR with symptoms of nasal obstruction sneezing and
itching may require pharmacotherapy However there are concerns regarding the safety of different available agents that
can be used during pregnancy with respect to both maternal and fetal well being
CONCLUSIONS
The best first-line approach in the management of AR is avoidance of allergens If environmental modification is
ineffective then the pharmacologic agents should be chosen For symptoms of rhinorrhea sneezing or itching
intranasal cromolyn with its excellent safety profile should be considered as first-line therapy If cromolyn is
ineffective or poorly tolerated first-generation (eg chlorpheniramine and tripelennamine) and second generation (eg
cetirizine and loratadine) antihistamines can be given Intranasal steroids (eg beclomethasone dipropionate
and budesonide) can be added to first-line therapy especially for severe nasal obstruction There are no
epidemiological studies with newer intranasal steroids (eg flunisolide triamcinolone acetonide fluticasone
propionate and mometasone furoate) during the first trimester of pregnancy Immunotherapy has not proven to be
teratogenic and is clinically useful in improving symptoms Oral and topical decongestants can be considered as second-
line therapy for short-term relief when no safer alternative is available
1httpwwwncbinlmnihgovpubmed15035567
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Terapaija astme tokom trudnoće
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Edukacija pacijenta o merama za prevenciju pogoršanja
alergijskog rinitisa i astme u trudnoći
Izbegavati alergene
Ispirati nos fiziološkim rastvorom
Pravilna primena preparata (nazalnih i inhalacionih)
Podrška adherenci
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Kapi za nos NE
Loratadin 10 mg dnevno DA
Montelukast 10 mg dnevno DA
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Mometazon 005 sprej za nos
dve aplikacije u svaku nozdrvu jednom dnevnoNE
Salmeterolflutikazon prašak za inhalaciju (diskus)
50 mikrogramadoza + 250 mikrogramadoza
- jedna inhalacija dva puta dnevnoDA
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Slučaj br3
U šestoj nedelji trudnoće pacijentkinji se pojavljuje mučnina koja joj je iscrpljujuća jer kako
navodi i više od pet puta povraća dnevno malaksala je zbog toga često dehidrira zbog
čega prima infuzije u Domu zdravlja i zbog svega ovoga je postala depresivna i često
plače
Ginekolog je preporučio upotrebu piridoksina i pacijentkinja ga koristi ali ne oseća se bolje
Nakon poslednjeg boravka u Domu zdravlja lekar opšte prakse joj je preporučio upotrebu tableta
metoklopramid 10 mg po potrebi ali je zamolio da se konsultuje sa Vama da li može da ovaj lek
primenjuje u trudnoći
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Metoklopramid u trudnoći
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
8Einarson A Maltepe C Boskovic R Koren G Treatment of nausea and vomiting in pregnancy an updated algorithm Can Fam Physician 2007532109-11
9Nausea and vomiting during pregnancy [revised 2011 Feb] In eTG complete [Internet] Melbourne Therapeutic Guidelines Limited 2013
wwwtgorgauindexphpsectionid=71
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Metoklopramid u trudnoći DA
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Slučaj br4
Pacijentkinja 8 mesec trudnoće dolazi u Vašu apoteku zbog umerenih bolova otoka i
crvenila u nogama
Pacijentkinji je ovo treća trudnoća a posle druge trudnoće počeli su problemi sa venama
(tromboflebitisom) Savetovana joj je upotreba čarapa za vene ali nije mogla da izdrži
preporučenu kompresiju
Primenjuje hladne obloge 3 borne kiseline i maže lokalno 1000IUg heparinski gel ali
se plaši da ne dođe do pogoršanja zbog čega želi dodatnu terapiju
Posle druge trudnoće pila je diosmin 600 mg (3x1 tabletu) tokom 5 dana koji joj je
pomagao i želi da zna da li može da primenjuje ovaj lek tokom trudnoće
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Diosmin u trudnoći
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
First epidemiological data for venotonics in pregnancy from the EFEMERIS database1
Isabelle Lacroix1Anna-Belle Beau1 Caroline Hurault-Delarue1Claire Bouilhac2 Dominique Petiot3 Christophe Vayssiegravere4Sabine Vidal5Jean-Louis
Montastruc1Christine Damase-Michel1
1Service de Pharmacologie Clinique CHU de Toulouse Universiteacute de Toulouse Toulouse2Protection Maternelle et Infantile Conseil Geacuteneacuteral Toulouse3PMSI
CHU de Toulouse4Centre de diagnostic anteacutenatal CHU de Toulouse5Caisse Primaire drsquoAssurance Maladie de la Haute-Garonne Toulouse
Abstract
Objective There are few published data about possible effects of veinotonics in pregnant women The present study investigates
potential adverse drug reactions of veinotonics in pregnancy
Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire
drsquoAssurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre) Women who
delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been
included in the EFEMERIS database We compared pregnancy outcomes and newborn health between women exposed to veinotonics
during pregnancy and unexposed women
Results We found that 8998 women (24) had received at least one prescription for venotonic agents during their pregnancy
corresponding to the period of organogenesis in 1200 cases We compared data for these women with those for the 27963 women
for whom these drugs were not prescribed during pregnancy The most widely used veinotonics were hesperidin diosmin and troxerutin
Pregnancies led to 984 versus 936 of live births 02 versus 02 of postnatal deaths and 16 versus 64 of pregnancy
termination (miscarriage ectopic pregnancy medical termination intrauterine death) in exposed and non-exposed groups respectively
The risks of pregnancy termination (HRthinsp=thinsp071 (060ndash084)) and prematurity (HRthinsp=thinsp082 (073ndash093)) remained significantly lower in the
women exposed to venotonics than in unexposed women In the group of newborns whose mother had a prescription of veinotonics
during organogenesis 39 out of 1200 (34) had a malformation versus 789 (30) in the control group (ORathinsp=thinsp1134 (0873ndash1472))
The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (49 versus 61 for the
controls ORathinsp=thinsp107 (095ndash120))
Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with
unexposed pregnant women
1httpphlsagepubcomcontentearly201506090268355515589679abstract
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Diosmin u trudnoći DA
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Slučaj br5
Pacijentkinja stara 38 godina po prvi put ostaje u drugom stanju
(tek potvrđena trudnoća10 dana) posle jednog pobačaja pre 8 meseci
Pacijentkinja boluje od reumatoidnog artritisa i na terapiji je
hydrochloroquinom već duže vremekoju je reumatolog promenio odmah
kada ga je obavestila da je u drugom stanju i propisao je sulfasalazin
Ranije je koristila methotrexat ali reumatolog joj je preporučio promenu
terapije pre godinu dana
Zabrunuta je za zdravlje bebe zbog upotrebe ovih lekova kao i da neće moći
da koristi ništa od NSAIDs (ibuprofen diklofenak i dr)i prednizolon koje
redovno koristi
Zabrinuta je i da li će moći da doji bebu ako ponovo počne da koristi ove
lekove nakon porođaja
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Hydrochloroquin
Sulfasalazin
Methotrexat
NSAIDs
Prednisolon
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
FDA kategorija klasifikacija
A Bez rizika u
kontrolisanim studijama
B Nema dokaza za rizik
kod ljudi
C Rizik nepoznat
D Pozitvni podaci o riziku
X Kontraindikovano u
trudnoći
N Nema podataka
Podaci nedovoljni zbog čega se kategorizacije razlikuju od kliničke prakse
Medications and
Motherrsquos Milk Hale
Thomas PhD 13th Edition 2008
Upotreba tokom
dojenja
L1 Najsigurniji
L2 Sigurni
L3 Umereno sigurni
L5
Rizični
L6
Kontraindikovani
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Hydroxychloroquine FDA kategorija C (rizik nepoznat)
odličan za umerene forme reumatoidnog artritisa
Kod sistemskog lupusa terapiju održavati tokom cele trudnoće
Sulfasalazin FDA kategorija B C i D
može se koristiti za aktivni reumatoidni artritis tokom cele trudnoće i dojenja
kod muškaraca obustaviti uzimanje leka 3 meseca pre planiranja začenja zbog mogućnosti pojave oligospermije
neophodna supstitucija folatima najmanje 3 meseca pre planiranja začeća kod oba pola
Methotrexat FDA kategorija X (kontraindikovan u trudnoći)
MORA SE ISKLJUČITI NAJMANJE TRI OVULATORNA CIKLUSA PRE ZAČEĆA DA BI SE IZBEGLA POJAVA ldquoaminopterin-methotrexat sindromardquo
Retardacija rasta neosifikovana calvaria hipoplastični supraorbitalni rubovi micrognatia male i loše formirane ušne školjke deformiteti ekstremiteta
MUŠKARCI TAKOĐE MORAJU DA PREKINU TERAPIJU 3 MESECA PRE ZAČEĆA
supstitucija folatima obavezna
dojenje se ne preporučuje
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Prednisolon ima FDA kategoriju C (rizik nepoznat)
zbog prijavljenih slučajeva rascepa nepca preranog pucanja plodovih ovojaka gestacionog dijabetesahipertenzije majke
prednisolon manje prelazi placentarnu barijeru za razliku od dexametazona i beta-metazona
većina kliničara ima iskustvo da je doza od 10mg (do max 20mg)dan bezbedna
NSAIDs
FDA kategorija B i C (nema dokaza za rizik kod ljudi ili rizik nepoznat)
svi prolaze placentu i smatraju se ˝potencijalno˝( mogući su pobačaji) bezbednim do kraja 32 nedelje
posle 32 nedelje ukoliko je aktivnost bolesti prisutna mogu se dati niske doze prednizolona i acetaminofen
upotreba u vreme porođaja može dovesti do produženog krvarenja ploda
COX-2 nisu dozvoljeni zbog rizika za razvoj kardiovaskularnog sistema i bubrega
Aspirin izbegavati u vreme dojenja (rizik od krvarenja kod deteta)
Antonucci R1 Zaffanello M Puxeddu E Porcella A Cuzzolin L Pilloni MD Fanos V Curr Drug Metab Use of non-steroidal anti-inflammatory drugs in
pregnancy impact on the fetus and newborn2012 May 113(4)474-90
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Hydrochloroquin DA
Sulfasalazin DA
Prednisolon DA
MethotrexatNE
NSAIDsNE
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Slučaj br6
Pacijentkinja 23 godine stara majka je petomesečne bebe
Nakon stomatološke posete ustanovljen je teži oblik gingivitisa za koju je stomatolog
preporučio upotrebu metronidazola 400 mg tri puta dnevno
Pacijentkinja Vas moli za savet da li može u narednih 5 dana da primenjuje ovaj lek pošto
doji bebu
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Metronidazole excretion in human milk and its effect on the suckling
neonate1
C M Passmore J C McElnay E A Rainey P F DArcyBr J Clin Pharmacol 1988 Jul 26(1) 45ndash51
1 Milk and plasma metronidazole and hydroxymetronidazole concentrations were measured in 12 breast-feeding patients following multiple doses of metronidazole (400 mg three times daily) All patients received metronidazole in combination with other broad spectrum antibiotics
2 Plasma concentrations of both parent drug and metabolite were measured in seven suckling infants Thirty-five infants were monitored for adverse reactions to maternal metronidazole therapy and two further groups of suckling infants those whose mothers received either ampicillin alone or no drug therapy were recruited as controls
3 The mean milk to plasma ratio (MP) was 09 for metronidazole and 076 for hydroxymetronidazole while the mean milk metronidazole concentrations (around Cmax) were 155 micrograms ml-1 The mean milk hydroxymetronidazoleconcentration was 57 micrograms ml-1
4 Infant plasma metronidazole concentrations ranged from 127 micrograms ml-1 to 241 micrograms ml-1 and the corresponding hydroxymetronidazole concentrations from 11 to 24 micrograms ml-1
5 There were no significant increases in adverse effects in infants which could be attributable to maternal metronidazole therapy
6 Metronidazole was excreted in milk at concentrations which caused no serious reactions in the infants studied The drug may therefore be administered at doses of 400 mg three times daily to mothers wishing to breast-feed their infants
1httpwwwncbinlmnihgovpmcarticlesPMC1386498
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Metronidazol tokom dojenjaDA
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
Zaključak Ishodi na nivou zdravstvenog sistema i društva
bull smanjenje faktora rizika za nastanak štetnih posledica od raznih agenasa
lekova za plod i majku
bull smanjenje posledičnih troškova
Ishodi na nivou apoteka
bull prepoznavanje apoteke od strane društva kao ustanove u kojoj se pružaju
uslugeintervencije zdravstvene zaštite
bull podrška unapređenju poslovanja apoteka od tradicionalne uloge u
obezbeđenju i izdavanju lekova ka pružanju javno-zdravstvenih usluga
Ishodi za trudnice i bebe
bull obezbeđenje najboljeg mogućeg zdravlja za majku i dete u kritičnom periodu
života
bull smanjenje troškova za pacijenta
bull ostvarivanje odnosa poverenja sa svojim farmaceutom iza koga stoji
odgovarajuća kompetentnost i kvalitet intervencije koju pruža
HVALA
jasnaurosevicyahoocom
HVALA
jasnaurosevicyahoocom