gracederm new glk

7/27/2019 Gracederm New GLK

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Introduction

A Trip le combinat ion of

CLOBETASOL PROPIONATE (superpo tent

steroid)

NEOMYCIN (anti bacterial)

CLOTRIMAZOLE (anti fu ngal)


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Secondary bacter ial and fu ngal infect ions are common in

stero id respon sive dermatoses

Combinat ion therapy with ant ib iot ic and anti-inf lammatory

agents or ant i fun gal and anti-inf lammatory agents h as been

prov ed to be effect ive in treatment of pr imary infected sk in

lesions and secondary infected dermatoses in number of

cl in ical stu dies.

Combinat ion of co rt icos teroids w ith ant ibacter ial and/orant i fungal agents h ave been shown to be very effect ive in

secondar i ly bacter ial and fungal infect ions oc curr in g in

steroid respons ive dermatoses.

Why triple combination??


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Steroid responsive dermatoses

Psoriasis

contact dermatitis

Atopic dermatitis

Chronic eczemas

Lichen sclerosis

Lichen simplex chronicus

Lichen planus


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Host factors

Lack of expression o f ant imicrobia l pept ides on skin in SRD

Increased adherence of s taph aureus to skin in atopicdermati t is

Comp rom ised skin barr ier funct ion

Reduced epidermal hydrat ion and sk in su rface l ip ids -increased colonizat ion wi th pathogens

Risk for s econdary infect ions m ay also be increased b y h ardscratch ing that abrade the skin and opens it to bacter ialinvasion

Hyperkeratot ic sk in favors fungal in fect ions


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Neomycin sulphateAm inoglyco side fami ly of agents

Neom ycin inter feres with bacter ial protein syn thesis.

Used to treat infect ion s caused by gram-negative and

aerob ic gram -pos it ive baci l l i (mainly s taphylo coc ci)

Ac tive against near ly al l gram negative organism s, with the

except ion of Pseudom onas and anaerobic o rganisms, suchas bacteroides.

Of the gram posi t ive organisms, staphylococc i are highly

sensi t ive. (staphy loco cc i are respo nsib le for 80% of the

secondary bacter ial infect ion s occu r ing in SRD)

Formulated alone or in combinat ion wi th other ant ib io t ics(baci tracin, po lymyx in B, gramicidin )

Most of ten combined wi th s tero ids.


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USES

First aid to help prevent infect ion in m inor cuts,

scraps, and burns

Eczema - top ical neom yc in + steroid is effect ive

for the

treatment of infected o r po tential ly infected eczema

Establ ishing viable skin graf ts in bu rn pat ients


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Allergic Contact Dermatitis and Neomycin

Despite its widespread use, the actual prevalenceof contact allergy with neomycin in the general

population is negligible. Actual incidence of

allergic contact dermatitis to neomycin in general

population to be 1% or less -- though some studies

have reported - drug allergy upto 10% .


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Other Adverse Effects

Ototoxicity and nephrotoxicity have been reported.

Hence should not be used over wide surface area.

Topical application of the drug, resistant

staphylococci have been reported.


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Clotrimazole

1s ttopical imidazole broad spectrum anti fun gal

Spectrum o f Act iv i ty

Candida speciesDermatophytes (Tr ichophy ton, Microsp orum , Epidermophy ton)

Malassezia furfur

Blastomy ces dermat i t id is , Coccid io ides imm it is , Histop lasma

capsulatum

Interrupts synthesis of ergosterolpermiabi l i ty of cel l

membrane.


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Uses

Topical Candidiasis

Complicated tinea infections

Secondary fungal infections in SRD


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Comparable safety and eff icacy w ith m iconazole and

econazole in su perf ic ia l mycoses.

In combinat ion w ith steroids ,Clotr imazole cream

demons trated better cl in ical results in pat ients of t in ea

infect ions than either agent alone did dur ing the f irst 3 to 5

days. Cure rates w ere at least as good or better than

com pared to clotr im azole alone.

Patients w ith t inea crur is or t inea co rpor is better

sym ptomat ic imp rovement wi th clotr imazole combined wi th

topic al steroid than either agent used individ ual ly

Clinical Studies


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Clotrimazole Vs Miconazole

In superficial skin infections with candida and in candidal

vaginitis miconazole and clotrimazole produced comparable

results.

Clotrimazole has more potent invitro MIC levels as compared

to miconazole against candida albicans

MIC of clotrimazole = 1to 2 mcg/ml

MIC of miconazole = 1to 4 mcg/ml


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Clobetasol Propionate

Clobetasol is an analog of predniso lone.

Class I- superpo tent steroid .

Chemical ly, clobetasol propionate is related to

halobetasol.


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Membrane phospholipids

Arachidonic acid

Prostaglandins and leukotrienes

Inflammation

Phospholipase A2

Top ical steroids

LipocortinsInhibition

Mechanism of action


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USES

Rel ief of inf lammatory and prur i t ic m ani festat ions

of hyperkeratot ic dermatoses (moderate to severe)

such as resistant atopic dermat i tis , contact

dermati t is, ch ron ic eczema, and psoriasis

Short term (2 weeks or less )

Conc : 0.05 percent c ream , gel and oin tment


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Place in therapy

Can be used for treat ing ch ronic , hyp erkeratot ic or

l ichenif ied lesions

More eff icacious th an f luocin onid e, betamathasone and

halcinon ide in treatment of psor iasis, eczema and other

refractory SRD.

Palms and so les have a thick s tratum co rneum , hence can

be used at these sites

Ointment bases are preferred as they enhance the

penetrat ion fo r extremely dry , thick , hyperkeratot ic

l ichenif ied sk in lesion s and creams for acute and subacutedermatoses

Class 1 steroid: approp r iate for plaque in regions exclu ding

face, axi l la, gro in and genitals


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For the treatment of cort ico steroid-responsive

dermatoses with secondary infect ion caused byorganism s suscept ib le to neomycin and

clotr imazole.

For the treatment of com plicated tinea infect ionby o rganisms suscept ib le to neomycin and

clotr imazole.

Indication


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DOSAGE:

Thin layer of Gracederm cream to the affected

sk in areas twice dai ly

Therapy shou ld be discont inued when contro l has

been achieved or up to a maximum of 2 weeks


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Precaut ions:

Gracederm cream is not for ophthalm ic use.

Not to be used in ch i ldren less th an 12 years age. Not to be large su rface areas, prolong ed use, and oc clus ivedressings

Not for appl icat ion on face & intertr ig inou s areas l ike groin oraxil lae

Fai lure to heal; may be evidence of al lergic co ntact dermati t is

Not fo r herpes, scabies, tubercu lar and viral skin disease,rosacea, per ioral dermati t is, uncontrol led in fect ion.

Dosage should not exceed 50 g per week

Not used > 2 weeks cont in uou sly, drug hol iday of at least 1week is required after 14 days o f con t inuo us use

If no im prov ement is seen w ithin 2 weeks , reassessment of

the diagnos is may be necessary. Due to the conc ern of nephrotox ic i ty and o totoxic i ty

associated wi th neomyc in, th is com bination sho uld no t beused over wide surface area.


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ADVERSE EFFECTS

Common: bu rn ing, st ing ing, or i tch ing.

skin atrophy , erythema, f issu r ing, fol l icul i t is, paresth esia,

num bness & telangiectasia.

str iae, acne, urt icar ia, hyp opigmentat ion, secondary infect ion,

miliaria.

Ointm ent for 16 days - (12% skin th ickness)

Rarely hypersens i t iv i ty - al lergic c ontact d ermati t is

Pustular psor iasis -withdrawal of clobetasol for plaque pso r iasis

used in higher doses >2 weeks .

Neom yc in can cause al lergic Con tact dermati t is, Ototox ici ty and

nephrotoxic i ty .


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Contraindications

Carcinogenesis and mutagenesis-Though

wel l contro l led animal or human studies

have no t done w ith the tr ip le combinat ion.

There is not much cause for concern as all

these three molecules have been used

safely for many years and there are no

repo rted cases.


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FAQs

1. What benef i t wi l l pat ient get with Gracederm?Ans - Gracederm conta in clob etasol propion ate which is a sup er potent

steroid, clotr imazole a t ime tested ant i fun gal and n eomycin

su lphate whic h is a broad spectrum ant ib acterial . It gives

3600coverage and quick rel ief f rom all d i rect ions in comp l icated

tinea.

2. Why the pr ice is Rs 45/- for 15 gm pack?

Ans - Al l the products f rom Gracewel l are known fo r i ts quali ty . We

never comp rom ise with the qual i ty of the produ cts. So w e are

buy ing the bu lk drug s at a higher rate from developed co untr ies.

Also you r patients qu ick re lie f is our co ncern and i t wi l l only com e

when Gracederm qu ali ty is good

3. Can Gracederm be used with oth er drugs?

Ans -Yes i t can b e used with o ther drugs but i t is advisable to use i t for a

sho r t per iod of t ime (not mo re than 2 weeks)


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FAQs

4. Why h ave you used the com binat ion of Clobetasol p ropion ate,

neomycin s ulphate and clot r imazole?

Ans We have added adequate amo unt of c ons t i tuents to d eliver the

adequate therapeut ic quant i t ies in infect ions .Als o,with the r ight

con centrat ion o f t r ip le combinat ion yo ur p atients wi l l have bet ter

pat ient comp l iance and have cost co nvenience.

5. Can Gracederm be used for infect ion caused by both

dermatophytes and Candida s pecies?

Ans -Yes doc tor ,Gracederm is ef fect ive in co ntro l o f bo th dermatophy tes

and Candid a species as it give 3600resolut ion to you r pat ients.

6. Can Gracederm be p resc ri bed to the ped iat ri c pat ien t s?

An s- It is recommended on ly to the pat ients above 12 yrs.


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gracederm new glk

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