product manual of toplevo

8/6/2019 Product Manual of Toplevo

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Product Manual:TOPLEVO

P R O D U C T B R I E F

NAME OF THE PRODUCT

Brand Name : Toplevo

Generic Name : Levofloxacin INN.

DOSAGE FORM & STRENGTH OF THE PRODUCT

1. Tablet : Levofloxacin 500 mg

DESCRIPTION OF THE PRODUCT

1. Toplevo 500F

Presentation : Round shaped tablet with off white color.

Packing : Alu-Alu Blister of 10 Tablets.

Pack Size : 3 10 Tablets in a box.

History

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Levofloxacin was first patented in 1987 by the Daiichi Pharmaceutical Co. Ltd. (now Daiichi

Seiyaku Pharmaceutical Co. Ltd - one of Japan's largest pharmaceutical companies.

Levofloxacin has been developed to take advantage of antibacterial potency requiring only

about half the usual dose of ofloxacin. Levofloxacin was first launched in Japan in 1993under the brand name Cravit. Levofloxacin was approved by the United States Food and

Drug Administration on December 20, 1996 by Ortho McNeil Pharmaceutical under the

name Levaquin, for use in the United States to treat severe and life-threatening bacterial

infections. Ranking 37th within the top 200 prescribed drugs in the United States for 2007

and ranked 19th in world sales in 2007, total sales for Levaquin were in excess of 1.6 billion

dollars. Levaquin was the most prescribed fluoroquinolone drug in the world for 2007.

Description

Toplevo (Levofloxacin) is a synthetic broad-spectrum antibacterial agent for oraladministration. Chemically, Toplevo (Levofloxacin) is a chiral fluorinated carboxyquinolone,

and the pure (-)-(S)-enantiomer of ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-

dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-

6-carboxylic acid hemihydrate.

Chemical Properties

The empirical formula is C18H20FN3O4 H2O and the molecular weight is 370.38.

Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder.

The molecule exists as a zwitter ion at the pH conditions in the small intestine.

From pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant

(approximately 100 mg/mL).

Levofloxacin is considered soluble to freely soluble in this pH range, as defined byUSP nomenclature.

Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL)

and is consideredfreely soluble in this range. Above pH 6.7, the solubility decreases

and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.

Levofloxacin has the potential to form stable coordination compounds with many

metal ions. This in vitro chelation potential has the following formation order: Al+3 >

Cu+2 > Zn+2 > Mg+2 > Ca+2.

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Pharmacokinetics

Absorption

Levofloxacin is rapidly and essentially completely absorbed after oral administration. Peakplasma concentrations are usually attained one to two hours after oral dosing. The absolute

bioavailability of levofloxacin from a 500 mg tablet and a 750 mg tablet of Levofloxacin are

both approximately 99%,

Distribution

The mean volume of distribution of levofloxacin ranges from 74 to 112 L after single and

multiple 500 mg or 750 mg doses, indicating widespread distribution into body tissues.

Levofloxacin reaches its peak levels in skin tissues and in blister fluid of at approximately 3

hours after dosing. Levofloxacin also penetrates well into lung tissues. Lung tissue

concentrations were generally 2- to 5- fold higher than plasma concentrations and ranged

from approximately 2.4 to 11.3 mcg/g over a 24-hour period after a single 500 mg oral dose.Levofloxacin is approximately 24 to 38% bound to serum proteins. Levofloxacin is mainly

bound to serum albumin in humans. Levofloxacin binding to serum proteins is independent of

the drug concentration.

Metabolism

Levofloxacin is stereochemically stable in plasma and urine and does not invert metabolically

to its enantiomer, D-ofloxacin. Levofloxacin undergoes limited metabolism in humans and is

primarily excreted as unchanged drug in the urine. Following oral administration,

approximately 87% of an administered dose was recovered as unchanged drug in urine within

48 hours, whereas less than 4% of the dose was recovered in feces in 72 hours. Less than 5%of an administered dose was recovered in the urine as the desmethyl and N-oxide metabolites,

the only metabolites identified in humans. These metabolites have little relevant

pharmacological activity.

Excretion

Levofloxacin is excreted largely as unchanged drug in the urine. The mean terminal plasma

elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single

or multiple doses of levofloxacin given orally. The mean apparent total body clearance and

renal clearance range from approximately 144 to 226 mL/min and 96 to 142 mL/min,

respectively. Renal clearance in excess of the glomerular filtration rate suggests that tubular

secretion of levofloxacin occurs in addition to its glomerular filtration. No levofloxacincrystals were found in any of the urine samples freshly collected from subjects receiving

Levofloxacin.

Mechanism of action

Levofloxacin is a bactericidal antibiotic (kills the bacteria). It inhibits DNA-gyrase in

susceptible organisms thereby inhibits relaxation of supercoiled DNA and promotes breakage

of DNA strands. DNA gyrase (topoisomerase II), is an essential bacterial enzyme that

maintains the superhelical structure of DNA and is required for DNA replication and

transcription, DNA repair, recombination, and transposition.

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Indication

Levofloxacin is indicated for the treatment of adults ( 18 years of age) with mild, moderate,

and severe infections caused by susceptible strains of the designated microorganisms in theconditions listed in this section.

o Acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae,

or Moraxella catarrhalis.

o Acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible

Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae,

Haemophilus parainfluenzae, or Moraxella catarrhalis.

o Nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus,

Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella

pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctivetherapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a

documented or presumptive pathogen, combination therapy with an anti-pseudomonal

b-lactam is recommended.

o Community-acquired pneumonia due to methicillin-susceptible Staphylococcus

aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus

parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia

pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.

o Complicated skin and skin structure infections due to methicillin-susceptible

Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus

mirabilis.

o Uncomplicated skin and skin structure infections (mild to moderate) includingabscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to

methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

o Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or

methicillin-susceptible Staphylococcus epidermidis.

o Complicated urinary tract infections (mild to moderate) due to Enterococcus

faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus

mirabilis, or Pseudomonas aeruginosa.

o Acute pyelonephritis (mild to moderate) caused by Escherichia coli.

o Uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli,

Klebsiella pneumoniae or Staphylococcus saprophyticus.o Inhalational anthrax (post-exposure) - to reduce the incidence or progression of

disease following exposure to aerosolized Bacillus anthracis

Dosage Schedule

The usual dose of Levofloxacin Tablets is 250 mg, 500 mg, or 750 mg administered orally

every 24 hours, as indicated by infection and described in Table 1. These recommendations

apply to patients with creatinine clearance 50 mL/min. For patients with creatinine

clearance < 50 mL/min, adjustments to the dosing regimen are required.

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Dosage in Adult Patients with Normal Renal Function

Type of Infection Every 24 hours Duration

(days)

Nosocomial Pneumonia 750 mg 7-14

Community Acquired Pneumonia 500 mg 7-14

Community Acquired Pneumonia 750 mg 5

Acute Bacterial Sinusitis 750 mg 500 mg 10-14

Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7

Complicated Skin and Skin Structure Infections 750 mg 7-14

Uncomplicated SSSI 500 mg 7-10

Chronic Bacterial Prostatitis 500 mg 28

Complicated Urinary Tract Infection (cUTI) or AcutePyelonephritis (AP) 750 mg 5

Complicated Urinary Tract Infection (cUTI) or Acute

Pyelonephritis (AP)

250 mg 10

Uncomplicated Urinary Tract Infection 250 mg 3

Inhalational Anthrax (Post-Exposure), adult and 500 mg 60

Dosage in Pediatric Patients 6 months of age

Type of Infection Dose Frequency Duration

Inhalational Anthrax (post-exposure)

Pediatric patients > 50 kg and 6

months of age500 mg 24hr 60 days

Pediatric patients < 50 kg and 6months of age

8 mg/kg (notto exceed 250

12hr 60 days

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mg per dose)

Side EffectsTendinopathy and Tendon Rupture

Toplevo increases risk oftendinitis and tendon rupture in all ages. This adverse reaction most

frequently involves the Achilles tendon, and rupture of the Achilles tendon may require

surgical repair. Tendinitis and tendon rupture in the rotator cuff(the shoulder), the hand, the

biceps, the thumb, and other tendon sites have also been reported.

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been

reported in patients receiving therapy with fluoroquinolones, including levofloxacin. These

reactions often occur following the first dose. Some reactions have been accompanied bycardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling,

angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway

obstruction (including bronchospasm, shortness of breath, and acute respiratory distress),

dyspnea,urticaria,itching, and other serious skin reactions.

Hepatotoxicity

Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most

cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with

hypersensitivity. The majority of fatal hepatotoxicity reports occurred in patients 65 years of

age or older and most were not associated with hypersensitivity.

Central Nervous System Effects

Convulsions and toxic psychoses have been reported in patients receiving fluoroquinolones,

including Levofloxacin. Fluoroquinolones may also cause increased intracranial pressure and

central nervous system stimulation which may lead to tremors, restlessness, anxiety,

lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and,

rarely, suicidal thoughts or acts.

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly allantibacterial agents, including Levofloxacin and may range in severity from mild diarrhea tofatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to

overgrowth ofC. difficile.

Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large

axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported

in patients receiving fluoroquinolones, including Levofloxacin.

Prolongation of the QT Interval

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Levofloxacin have been associated with prolongation of the QT interval on the

electrocardiogram and infrequent cases ofarrhythmia. Rare cases of torsade de pointes have

been spontaneously reported during postmarketing surveillance in patients receiving

Levofloxacin.

Musculoskeletal Disorders in Pediatric Patients

Levofloxacin is indicated in pediatric patients ( 6 months of age) only for the prevention of

inhalational anthrax (post-exposure). An increased incidence of musculoskeletal disorders

(arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been

observed in pediatric patients receiving Levofloxacin

Blood Glucose Disturbances

As with other fluoroquinolones, disturbances of blood glucose, including symptomatichyper-

and hypoglycemia, have been reported with Levofloxacin, usually in diabetic patientsreceiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with

insulin.

Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest

as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering,

edema) involving areas exposed to light (typically the face, V area of the neck, extensor

surfaces of the forearms, dorsa of the hands), can be associated with the use of Levofloxacin

after sun or UV light exposure.

Development of Drug Resistant Bacteria

Prescribing Levofloxacin in the absence of a proven or strongly suspected bacterialinfection

or aprophylacticindication is unlikely to provide benefit to the patient and increases the risk

of the development of drug-resistant bacteria

Drug Interaction

Chelation Agents:

Concurrent administration of Levofloxacin with antacids containing magnesium, or

aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations

with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in

systemic levels considerably lower than desired.

Warfarin

No apparent effect of warfarin on levofloxacin absorption and disposition was observed.

However, there have been reports during the postmarketing experience in patients that

Levofloxacin enhances the effects of warfarin. Elevations of the prothrombin time in the

setting of concurrent warfarin and Levofloxacin use have been associated with episodes of

bleeding. Prothrombin time.

Antidiabetic Agents

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Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been

reported in patients treated concomitantly with Levofloxacin and an antidiabetic agent.

Non-Steroidal Anti-Inflammatory Drugs

The concomitant administration of a non-steroidal anti-inflammatory drug with a

Levofloxacin may increase the risk of CNS stimulation and convulsive seizures.

Theophylline

Concomitant administration of other fluoroquinolones with theophylline has resulted in

prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase

in the risk of theophylline-related adverse reactions in the patient population.

Cyclosporine

Elevated serum levels of cyclosporine have been reported in the patient when co-

administered with some other fluoroquinolones. Levofloxacin Cmax and ke were slightly

lower while Tmax and t1/2 were slightly longer in the presence of cyclosporine than those

observed in other studies without concomitant medication.

Digoxin

No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other

disposition parameters for digoxin was detected in a clinical study involving healthy

volunteers. Levofloxacin absorption and disposition kinetics were similar in the presence or

absence of digoxin. Therefore, no dosage adjustment for Levofloxacin or digoxin is required

when administered concomitantly.

Probenecid and Cimetidine

No significant effect of probenecid or cimetidine on the Cmax of levofloxacin was observed

in a clinical study involving healthy volunteers. The AUC and t1/2 of levofloxacin were higher

while CL/F and CLR were lower during concomitant treatment of Levofloxacin with

probenecid or cimetidine compared to Levofloxacin alone.

Interactions with Laboratory or Diagnostic Testing

Levofloxacin may produce false-positive urine screening results for opiates using

commercially available immunoassay kits. Confirmation of positive opiate screens by morespecific methods may be necessary.

Contraindication

Toplevo (Levofloxacin) is contraindicated in patients with a known hypersensitivity to

levofloxacin or other quinolone drugs. It is also contraindicated for the treatment of certain

sexually transmitted diseases by some experts due to bacterial resistance. Levofloxacin is also

considered to be contraindicated in patients withepilepsy or other seizure disorders.

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Use in specific populationPregnancy

Pregnancy Category C. Levofloxacin was not teratogenic in rats at oral doses as high as 810

mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon

relative body surface area, or at intravenous doses as high as 160 mg/kg/day corresponding to

1.9 times the highest recommended human dose based upon relative body surface area. The

oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal

mortality. No teratogenicity was observed when rabbits were dosed orally as high as 50

mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon

relative body surface area, or when dosed intravenously as high as 25 mg/kg/day,

corresponding to 0.5 times the highest recommended human dose based upon relative bodysurface area.

There are, however, no adequate and well-controlled studies in pregnant women.

Levofloxacin should be used during pregnancy only if the potential benefit justifies the

potential risk to the fetus.

Nursing Mothers

Based on data on other fluoroquinolones and very limited data on Levofloxacin, it can be

presumed that levofloxacin will be excreted in human milk. Because of the potential for

serious adverse reactions from Levofloxacin in nursing infants, a decision should be madewhether to discontinue nursing or to discontinue the drug, taking into account the importance

of the drug to the mother.

Pediatric Use

Levofloxacin causes arthropathy and osteochondrosis injuvenile animals of several species.

Levofloxacin is indicated in pediatric patients ( 6 months of age) only for the prevention of

inhalational anthrax (post-exposure)

Inhalational Anthrax (Post-Exposure)

Levofloxacin is indicated in pediatric patients for inhalational anthrax (post-exposure). The

risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is

appropriate. The safety of levofloxacin in pediatric patients treated for more than 14 days has

not been studied. The pharmacokinetics of levofloxacin following a single intravenous dose

were investigated in pediatric patients ranging in age from six months to 16 years.

Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including

tendon rupture when being treated with Levofloxacin. This risk is further increased in

patients receiving concomitant corticosteroid therapy. Tendonitis or tendon rupture can

involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after

completion of therapy; cases occurring up to several months after Levofloxacin treatmenthave been reported.

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Renal Impairment

Clearance of levofloxacin is substantially reduced and plasma elimination half-life issubstantially prolonged in patients with impaired renal function (creatinine clearance < 50

mL/min), requiring dosage adjustment in such patients to avoid accumulation. Neither

hemodialysis nor continuous ambulatoryperitoneal dialysis (CAPD) is effective in removal

of levofloxacin from the body, indicating that supplemental doses of Levofloxacin are not

required following hemodialysis or CAPD.

Hepatic Impairment

Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the

limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not

expected to be affected by hepatic impairment.

Over Dose

In the event of an acute overdosage, the stomach should be emptied. The patient should be

observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by

hemodialysis orperitoneal dialysis.

Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys

exhibited the following clinical signs after receiving a single high dose of Levofloxacin :

ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions.Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in

rodents.

Warnings and Precautions

Tendinopathy and Tendon Rupture

Levofloxacin should be discontinued if the patient experiences pain, swelling, inflammation

or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis ortendon rupture, and to contact their healthcare provider regarding changing to a non-

quinolone antimicrobial drug.

Hypersensitivity Reactions

Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any

other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment

with epinephrine and other resuscitative measures, including oxygen, intravenous fluids,

antihistamines, corticosteroids, pressor amines, and airway management, as clinically

indicated

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Hepatotoxicity

The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older andmost were not associated with hypersensitivity. Levofloxacin should be discontinued

immediately if the patient develops signs and symptoms of hepatitis

Central Nervous System Effects

Levofloxacin should be used with caution in patients with a known or suspected central

nervous system (CNS) disorder that may predispose them to seizures or lower the seizure

threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk

factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug

therapy, renal dysfunction

Clostridium difficile-Associated Diarrhea

IfClostridium difficile-associated diarrhea (CDAD) is suspected or confirmed, ongoing

antibiotic use not directed against C difficile may need to be discontinued. Appropriate fluidand electrolyte management, protein supplementation, antibiotic treatment ofC. difficile, and

surgical evaluation should be instituted as clinically indicated.

Peripheral Neuropathy

Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy

including pain, burning, tingling, numbness, and/or weakness or other alterations ofsensation

including light touch, pain, temperature, position sense, and vibratory sensation in order toprevent the development of an irreversible condition.

Prolongation of the QT Interval

Levofloxacin should be avoided in patients with known prolongation of the QT interval,

patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine,

procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may

be more susceptible to drug-associated effects on the QT interval.

Musculoskeletal Disorders in Pediatric Patients

Levofloxacin is indicated in pediatric patients ( 6 months of age) only for the prevention ofinhalational anthrax (post-exposure). An increased incidence of musculoskeletal disorders

(arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been

observed in pediatric patients receiving Levofloxacin.

Blood Glucose Disturbances

In diabetic patients, careful monitoring of blood glucose is recommended. If a hypoglycemic

reaction occurs in a patient being treated with Levofloxacin, Levofloxacin should be

discontinued and appropriate therapy should be initiated immediately.

Photosensitivity/Phototoxicity

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Excessive exposure to these sources of light should be avoided. Drug therapy should be

discontinued if photosensitivity/phototoxicity occurs

StorageStore at room temperature between 59-86 degrees F (15-30 degrees C) in a tightly closed

container away from light and moisture. Do not store in the bathroom. Keep all medicines

away from children. Do not flush medications down the toilet or pour them into a drain

unless instructed to do so. Properly discard this product when it is expired or no longer

needed.

Advantages and Disadvantages

Advantages

Toplevo (Levofloxacin) is convenient once-daily dosing - this is of particular benefit

in those patients who may not be compliant

Toplevo (Levofloxacin) is rapidly bactericidal with a broad spectrum of activity

Toplevo (Levofloxacin) is better safety and tolerability- one of the least likely

fluoroquinolones to cause any cardiovascular effects, central nervous system

disturbances and phototoxicity

Toplevo (Levofloxacin) has less significant drug interactions than with other

fluoroquinolones, as levofloxacin does not have a major P-450 metabolism

Toplevo (Levofloxacin) has relatively low emergence of resistant organisms

Toplevo (Levofloxacin) shows expanded gram-positive spectrum of activity

(including Streptococcus pneumoniae)

Toplevo (Levofloxacin) provides moderate anaerobic activity (most quinolones

possess weak activity against anaerobes)

Toplevo (Levofloxacin) is currently the only respiratory fluoroquinolone approved

for the treatment of nosocomial pneumonia

Toplevo (Levofloxacin) has excellent bioavailability about 99% after oral

administration

Treatment of acute exacerbations of chronic obstructive pulmonary disease with

Toplevo (Levofloxacin) may reduce hospitalizations compared with standardantibiotics

Toplevo (Levofloxacin) may be a good choice in persons with liver disease in whom

other fluoroquinolones are contraindicated

Toplevo (Levofloxacin) does not interact with alcohol

Disadvantages:

Toplevo (Levofloxacin) is not active against methicillin-resistant staphylococci,

including S. aureus, S. epidermidis and S. haemolyticus

Toplevo (Levofloxacin) has the risk oftendon ruptures (this risk may be increased inpersons taking corticosteroids, especially the elderly)

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Toplevo (Levofloxacin) has risk of peripheral neuropathy (nerve damage), the

symptoms include pain, burning, tingling, numbness, weakness, other alterations of

sensation

Toplevo (Levofloxacin) has risk of prolongation of the QT interval, arrhythmia, andrare cases of torsades de pointes

Toplevo (Levofloxacin) exerts central nervous system and psychiatric side effects,

such as convulsions, confusion, anxiety, depression, and insomnia

Toplevo (Levofloxacin) may delay the fracture healing. Use of levofloxacin during

early fracture repair may compromise the clinical course of fracture-healing.

Comperison with Other drugs

Levofloxacin versus Other Medications

According to the studies, the rank order of phototoxic potential of fluoroquinolones is as

follows: enoxacin> ciprofloxacin > norfloxacin = ofloxacin = levofloxacin = gatifloxacin =

moxifloxacin

Based on published literature, the approximate order of fluoroquinolones in which they

significantly interact with theophylline is as follows: enoxacin > ciprofloxacin > norfloxacin

> ofloxacin, levofloxacin, trovafloxacin, gatifloxacin, moxifloxacin.

Levofloxacin was found to be very safe with a low rate of hepatic abnormalities (1/650,000).

Levofloxacin, ofloxacin, and moxifloxacin reportedly have the lowest potential of inducing

central nervous system (CNS) adverse events among the fluoroquinolones currentlyavailable.

Cardiovascular problems were seen in 1/15 million levofloxacin prescriptions compared to 1-

3% of sparfloxacin patients having QTc prolongation of greater than 500 msec. Moxifloxacin

was also associated with QTc prolongation when compared to non-fluoroquinolone

comparators.

Nausea, vomiting, and diarrhoea remain the main adverse drug reactions associated with

levofloxacin. However, the ADR rate for levofloxacin is still one of the lowest of any

fluoroquinolone at 2% (compared to 2-10% for other fluoroquinolones).

The tolerance profile of levofloxacin can be considered to be very good, and better than most,

if not all of the fluoroquinolones available.

Levofloxacin vs. Ciprofloxacin

Skin and Skin Structure Infections:

Among 253 patients (129 levofloxacin, 124 ciprofloxacin), clinical success (cure and

improvement) was observed in 96.1% of levofloxacin-treated patients and in 93.5% of

ciprofloxacin-treated patients. Bacteriological eradication rates by pathogen were 93.2% and

91.7%, respectively. Levofloxacin eradicated 94% (66/70) of Staphylococcus aureus and

94% (17/18) of Streptococcus pyogenes isolates, compared with 93% (70/75) and 92%(12/13) for ciprofloxacin. Microbiological eradication rates by subject were approximately

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93% and 90% for the levofloxacin and ciprofloxacin groups, respectively. Drug-related

adverse events were reported by 8.9% of those receiving levofloxacin and 8.2% of those

administered ciprofloxacin

Acute Pyelonephritis, Urinary tract infections (UTI):

Levofloxacin 750 mg once daily for 5 days is at least as effective as ciprofloxacin 400 mg or

500 mg twice daily for 10 days in the treatment of acute pyelonephritis 13.

In the modified intent-to-treat (mITT) population (levofloxacin 94, ciprofloxacin 98), 83% of

levofloxacin-treated and 79.6% of ciprofloxacin-treated subjects achieved microbiological

eradication (difference 3.4, 95% CI 14.4%, 7.6%). In the microbiologically evaluable (ME)

population (levofloxacin 80, ciprofloxacin 76), 92.5% of levofloxacin-treated vs. 93.4% of

ciprofloxacin-treated subjects (difference 0.9, 95% CI 7.1%, 8.9%) achieved microbiologic

eradication. Clinical success was achieved in 86.2% vs. 80.6% (mITT) and in 92.5% vs.

89.5% (ME) of levofloxacin-treated and ciprofloxacin-treated subjects, respectively.

Escherichia coli was the most commonly isolated uropathogen. Few (2.1%) of the pathogens

were fluoroquinolone-resistant. Adverse events (AEs) were similar to those seen previously

with both agents. Potential limitations are that this analysis is based on a subset of subjects

from a larger study and, because of different durations of therapy, the results may be biased

against levofloxacin.

Chronic bacterial prostatitis:

Levofloxacin 500 mg once daily for 28 days is as effective as ciprofloxacin 500 mg twice

daily for 28 days for the treatment of chronic bacterial prostatitis. The clinical success rates,

including cured plus improved patients, were similar (75% for levofloxacin and 72.8% forciprofloxacin). Microbiologic eradication rates were 75% for levofloxacin and 76.8% for

ciprofloxacin.

Levofloxacin (Levaquin) vs. Lomefloxacin

Urinary Tract Infections:

Once-daily levofloxacin is as effective as and has a superior tolerability profile than

lomefloxacin in the treatment of complicated UTIs Microbiologic eradication rate of

pathogens was 95.5% for levofloxacin and 91.7% for lomefloxacin. At the 5 to 9-day post-therapy visit, symptoms were completely resolved in 84.8% of levofloxacin-treated patients

and were decreased in 8.2% (93.0% clinical success). Among the lomefloxacin-treated

patients, complete resolution was seen in 82.4%, with decreased symptoms in 6.1% (88.5%

clinical success). Side effects were reported by 10 (2.6%) and 18 (5.2%) levofloxacin- and

lomefloxacin-treated patients, respectively. Compared with levofloxacin-treated patients,

more lomefloxacin-treated patients experienced photosensitivity reactions and dizziness.

Nausea was more frequent in the levofloxacin-treated group. Six patients in each treatment

group had a gastrointestinal side effects (1.7%); rash was reported more frequently with

lomefloxacin than with levofloxacin. Discontinuation because of side effects was occured in

8 (3.4%) levofloxacin- and 14 (6.1%) lomefloxacin-treated patients.

Acute Pyelonephritis:

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Predominant organism was E. coli Eradication rates similar 95%(Le) 95%(Lo) Relapse rates

were similar Clinical cure (microbiologic and clinical success) rates 92%(Le) 80%(Lo) Rates

of clinical success (cure plus improvement) were similar Adverse events 2%(Le) 5%(Lo)

Levofloxacin vs. Clarithromycin

Bacterial exacerbation of chronic obstructive pulmonary disease (COPD).

In the study levofloxacin and clarithromycin showed similar exacerbation-free intervals. The

bacteriological eradication rate was significantly higher with the levofloxacin treatment.

Community-acquired pneumonia:

Clarithromycin ER has equivalent efficacy and tolerability to the levofloxacin in the

treatment of community-acquired pneumonia. Of 299 patients randomized and treated, 252

were clinically evaluable (128 clarithromycin ER, 124 levofloxacin). Clinical cure rates were

88% (113/128) and 86% (107/124), and radiographic success rates were 95% (117/123) and88% (104/118) for clarithromycin ER and levofloxacin, respectively. Both treatment

regimens were effective in resolving and improving clinical signs and symptoms of CAP.

Bacteriologic cure rates were 86% (80/93) and 88% (85/97) for clarithromycin ER and

levofloxacin, respectively.

Acute sinusitis:

The study showed that, in the treatment of acute sinusitis, daily levofloxacin therapy is as

effective as twice-daily clarithromycin therapy with more complete clearing of symptoms and

a more tolerable side-effect profile. The proportion of cured patients was higher in the

levofloxacin (40.8%) than in the clarithromycin group (29.0%). Of patients receiving

levofloxacin and clarithromycin, 22.5% and 39.3%, respectively, experienced adverse eventsrelated or possibly related to the study therapy.

Levofloxacin vs. Azithromycin

Acute bacterial exacerbations of chronic bronchitis.

Standard 5-day course of oral azithromycin was clinically and bacteriologically equivalent to

a 7-day course of oral levofloxacin in the treatment of ABECB. Favorable results were

demonstrated in 89% of patients receiving azithromycin and in 92% of patients receiving

levofloxacin by day 4 of therapy. At day 24 favorable responses were approximately 82%

and 86%, respectively. The bacterial eradication rates of respiratory pathogens were 96% for

azithromycin and 85% for levofloxacin


A single 2 g dose of azithromycin microspheres is at least as effective as a 7-day course of

levofloxacin in the treatment of mild to moderate community-acquired pneumonia. The cure

rates were 89.7% for azithromycin microspheres and 93.7% for levofloxacin. Bacteriologic

success at test of cure in the "bacteriologic per protocol" population was 90.7% for

azithromycin microspheres and 92.3% for levofloxacin. Both medications were well

tolerated. The incidence of side effects was 19.9% for azithromycin and 12.3% for

levofloxacin.

Sinusitis:

Single 2 g dose azithromycin microspheres has efficacy comparable to 10 days oflevofloxacin in the treatment of acute bacterial sinusitis. Clinical success rates were 94.5%

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with azithromycin-microspheres and 92.8% with levofloxacin. In patients with Streptococcus

pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were

97.3%, 96.3%, and 100%, respectively, for the azithromycin and 92.3%, 100%), and 90.9%,

respectively, for the levofloxacin.

Levofloxacin vs. Cefuroxime axetil

Acute bacterial exacerbations of chronic bronchitis (ABECB):

The clinical response was rated a success, with the patient cured or improved in 94.6% of

those receiving levofloxacin and 92.6% of the cefuroxime axetil group. All of the symptoms

of bronchitis were resolved in more than 86% of the patients, with the exception of shortness

of breath, which resolved in 69.7% of levofloxacin-treated and 72.4% of cefuroxime axetil-

treated patients.


Levofloxacin is superior to ceftriaxone and/or cefuroxime axetil in the treatment of

community-acquired pneumonia Clinical success was higher with levofloxacin treatment

(96%) compared with the ceftriaxone and/or cefuroxime axetil (90%). In patients with typical

respiratory pathogens the bacteriologic eradication rates were higher with levofloxacin (98%)

compared with the ceftriaxone and/or cefuroxime axetil (85%). Levofloxacin eradicated

100% of the most frequently reported respiratory pathogens (i.e., H. influenzae and S.

pneumoniae) and provided a >98% clinical success rate in patients with atypical pathogens.

Sinusitis:

Levofloxacin is more effective than cefuroxime for the treatment of sinusitis.In the study the treatment success rates were 97.4% for patients who received levofloxacin

and 92.8% for patients who received cefuroxime. The resolution rates of bacteria were 91.6%

and 80.0%, respectively.

Levofloxacin vs. Cefdinir

Rhinosinusitis:

Cefdinir is effective as the levofloxacin in the treatment of acute rhinosinusitis.

Clinical cure rate at the test-of-cure visit in the cefdinir group was 83% and in the

levofloxacin group 86%. Cefdinir and levofloxacin were comparable in the treatment of

moderate to severe infections. The incidence of drug side effects was generally comparable in

the 2 treatment groups, although there were significant differences between cefdinir andlevofloxacin in the incidence of vaginal moniliasis in women (11% vs 0%), diarrhea (8% vs

1%), and insomnia (0% vs 4%).

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