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AKORN INC.
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17478071310

ofloxacin 0.3% eye drops (generic ocuflox)

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Uses

Ofloxacin ophthalmic solution is used in the treatment of keratitis and conjunctivitis caused by susceptible bacteria. Prior to initiation of topical ophthalmic ofloxacin therapy, appropriate specimens generally should be collected for identification of the causative organism and in vitro susceptibility tests. Ofloxacin may be started pending results of susceptibility tests but should be discontinued and other more appropriate therapy instituted if the causative organism is shown to be resistant to ofloxacin.

Ofloxacin otic solution is instilled into the ear canal for the treatment of otitis externa, chronic suppurative otitis media, or acute otitis media caused by susceptible bacteria.

Ophthalmic Infections

Keratitis

Ofloxacin ophthalmic solution is used in the treatment of keratitis (corneal ulcers) caused by susceptible Pseudomonas aeruginosa, Propionibacterium acnes, Serratia marcescens, Staphylococcus aureus, S. epidermidis, or Streptococcus pneumoniae; the drug is designated an orphan drug by the US Food and Drug Administration (FDA) for this use. Results of comparative studies in patients receiving a fluoroquinolone ophthalmic solution (e.g., ciprofloxacin, ofloxacin) for bacterial keratitis suggests that such therapy produces results comparable to those observed with more complex treatment regimens (e.g., a topical ''fortified'' aminoglycoside used in conjunction with a topical cephalosporin).

Results from a randomized, double-blind, multicenter clinical study in patients with bacterial keratitis indicate that ofloxacin ophthalmic solution is as effective as a topical regimen consisting of tobramycin 1.5% solution and cefazolin 10% solution (prepared extemporaneously; not commercially available in the US). In this study, treatment with ofloxacin 0.3% ophthalmic solution in the recommended dosage resulted in clinical cure (i.e., complete reepithelization and no progression of the infiltrate on 2 consecutive visits) in 82% of patients compared with 80% of those receiving therapy with topical tobramycin 1.5% used concomitantly with topical cefazolin 10%. While nonprogression of infiltrate usually occurred about 3 days after initiating therapy with either regimen, time to clinical cure occurred in about 11 or 10 days in patients receiving topical ofloxacin or concomitant therapy with topical tobramycin and topical cefazolin, respectively. In this study, success of ofloxacin therapy did not depend on the patient's age, initial size of the epithelial defect, depth of stromal infiltrate, or presence of anterior chamber inflammation.

Conjunctivitis

Ofloxacin ophthalmic solution is used for the treatment of conjunctivitis caused by susceptible Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, Ps. aeruginosa, S. aureus, S. epidermidis, or S. pneumoniae.

Although most cases of acute bacterial conjunctivitis improve without anti-infective therapy, topical application of anti-infectives may shorten the infectious process. In addition, topical application of anti-infectives may reduce recurrence rate and morbidity associated with bacterial conjunctivitis.

Results from several controlled studies indicate that ofloxacin 0.3% ophthalmic solution is more effective than placebo (vehicle) and as effective as chloramphenicol 0.5%, gentamicin 0.3%, or tobramycin 0.3% ophthalmic solution in the treatment of acute bacterial conjunctivitis caused by various gram-positive and/or -negative pathogens. In these studies, which generally included patients with acute conjunctivitis as well as some with blepharoconjunctivitis or blepharitis, efficacy was established in terms of reduction or eradication of bacterial conjunctival pathogens and improvement in ocular manifestations (e.g., discharge, chemosis, hyperemia, lid edema/ erythema, burning/pain, foreign body sensation, corneal edema). Topical application of ofloxacin 0.3% ophthalmic solution to the eye for 7-10 days was effective in reducing or eradicating all conjunctival pathogens in 78-85% of patients with bacterial conjunctivitis, blepharoconjunctivitis, or blepharitis and produced clinical improvement in virtually all patients.

Otic Infections

Otitis Externa

Ofloxacin otic solution is instilled into the ear canal for the treatment of otitis externa caused by susceptible Escherichia coli, S. aureus or P. aeruginosa. Results of comparative studies in adults and children with otitis externa indicate that ofloxacin otic solution is as effective as combined neomycin, polymyxin B, and hydrocortisone (e.g., Cortisporin) otic solution as evaluated by clinical and microbiologic response.

Although acute bacterial otitis externa localized in the external auditory canal may be effectively treated using topical anti-infectives (e.g., ciprofloxacin otic suspension, ofloxacin otic solution), malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients such as those with diabetes mellitus or human immunodeficiency virus (HIV) infection, and requires prompt diagnosis and long-term treatment with parenteral anti-infectives (e.g., ceftazidime and/or ciprofloxacin).

Chronic Suppurative Otitis Media

Ofloxacin otic solution is instilled into the ear canal in patients with perforated tympanic membranes for the treatment of chronic suppurative otitis media (CSOM) caused by susceptible S. aureus, P. mirabilis, or P aeruginosa. Because commercially available ofloxacin otic solution is sterile, unlike ciprofloxacin and hydrocortisone otic suspension (which is nonsterile), the ofloxacin otic solution can be used in the treatment of otic infections even when the tympanic membrane is perforated.

In one open label study in patients with chronic suppurative otitis media and a chronically perforated tympanic membrane in the infected ear(s), treatment with ofloxacin otic solution resulted in complete resolution of otorrhea 7-10 days after completion of therapy in 91% of patients and microbiologic response in 100% of evaluable patients.

Topical anti-infectives (e.g., ciprofloxacin otic suspension, ofloxacin otic solution, gentamicin) used in conjunction with daily aural toilet can be effective for the treatment of uncomplicated CSOM; more severe or persistent infections require treatment with a parenteral anti-infective (e.g., ceftazidime, clindamycin, ciprofloxacin, gentamicin, ticarcillin, ticarcillin disodium and clavulanate potassium).

Acute Otitis Media

Ofloxacin otic solution is instilled into the ear canal in patients with tympanostomy tubes for the treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or P. aeruginosa.

Systemic Uses

For systemic uses of ofloxacin,

Dosage and Administration

Administration

Ofloxacin is applied topically to the eye as an ophthalmic solution or instilled into the ear as an otic solution. Care should be taken to avoid contamination of the solution container.The commercially available ofloxacin ophthalmic solution is not for injection and should not be injected subconjunctivally or directly into the anterior chamber of the eye. The commercially available ofloxacin otic solution is not for ophthalmic use or for injection.

Prior to administration, ofloxacin otic solution should be warmed by holding the bottle in the hand for 1-2 minutes since instillation of a cold solution into the ear canal could precipitate dizziness.

Commercially available ofloxacin otic solution is supplied in multidose and single-use containers.

Dosage

Ophthalmic Infections

Keratitis

For the treatment of bacterial keratitis, the manufacturer recommends that ofloxacin ophthalmic solution be administered around the clock for the first 2 days of therapy. The dosage of ofloxacin recommended by the manufacturer for the treatment of this infection in adults and children 1 year of age and older is 1 or 2 drops of a 0.3% solution in the affected eye(s) every 30 minutes while awake and then 4 and 6 hours after retiring, for 2 days. Beginning on the third day of therapy, 1 or 2 drops of the solution may be instilled in the affected eye(s) every hour while awake for up to an additional 4-6 days. Afterward, 1 or 2 drops of the solution may be instilled in the affected eye(s) 4 times daily for an additional 3 days or until clinical cure is achieved.

Conjunctivitis

For the treatment of bacterial conjunctivitis, ofloxacin ophthalmic solution usually is administered during waking hours, rather than around the clock. The dosage of ofloxacin recommended by the manufacturer in adults and children 1 year of age and older is 1 or 2 drops of a 0.3% solution in the affected eye(s) every 2-4 hours while awake for 2 days, then 1 or 2 drops 4 times daily for up to 5 more days.

Otic Infections

Otitis Externa

For the treatment of bacterial otitis externa in children 6 months to 13 years of age, 5 drops of ofloxacin otic solution (0.25 mL, 0.75 mg of ofloxacin) are instilled into the canal of the affected ear(s) once daily for 7 days.When ofloxacin otic solution is administered using the single-use container, the contents of one container (0.25 mL) are instilled into the canal of the affected ear(s) once daily for 7 days in children 6 months to 13 years of age.

For the treatment of bacterial otitis externa in adults and adolescents 13 years of age or older, 10 drops of ofloxacin otic solution (0.5 mL, 1.5 mg of ofloxacin) are instilled into the canal of the affected ear(s) once daily for 7 days. When ofloxacin otic solution is administered using the single-use containers, the contents of two containers (0.5 mL) are instilled into the canal of the affected ear(s) once daily for 7 days in adults and adolescents 13 years of age or older.

The patient should lie with the affected ear upward and the solution instilled into the ear canal; this position should be maintained for 5 minutes to facilitate penetration of the drops into the ear. This procedure should be repeated if necessary for the opposite ear.

Chronic Suppurative Otitis Media

For the treatment of chronic suppurative otitis media in adults and adolescents 12 years of age or older with perforated tympanic membranes, 10 drops of ofloxacin otic solution (0.5 mL, 1.5 mg of ofloxacin) are instilled into the canal of the affected ear(s) twice daily for 14 days. When ofloxacin otic solution is administered using the single-use containers, the contents of two containers (0.5 mL) are instilled into the canal of the affected ear(s) twice daily for 14 days in adults and adolescents 12 years of age or older with perforated tympanic membranes.

The patient should lie with the affected ear upward and the solution instilled into the ear canal; the tragus of the ear should be pumped 4 times by pushing inward to facilitate penetration of the drops into the ear. The position should be maintained for 5 minutes. This procedure should be repeated if necessary for the opposite ear.

Acute Otitis Media

For the treatment of acute otitis media in children 1-12 years of age with tympanostomy tubes, 5 drops of ofloxacin otic solution (0.25 mL, 0.75 mg of ofloxacin) are instilled into the canal of the affected ear(s) twice daily for 10 days. When ofloxacin otic solution is administered using the single-use container, the contents of one container (0.25 mL) are instilled into the canal of the affected ear(s) twice daily for 10 days in children 1-12 years of age.

The patient should lie with the affected ear upward and the solution instilled into the ear canal; the tragus of the ear should be pumped 4 times by pushing inward to facilitate penetration of the drops into the ear. The position should be maintained for 5 minutes. This procedure should be repeated if necessary for the opposite ear.

Cautions

Ofloxacin ophthalmic solution and otic solution generally are well tolerated following topical application.

Ocular Effects

The most frequent adverse effects of topical ofloxacin are transient ocular burning or discomfort following instillation of the solution. Conjunctival hyperemia, chemical conjunctivitis/keratitis, foreign body sensation, blurred vision, periocular/facial edema, eye pain, photophobia, pruritus, stinging, tearing, and dryness also have been reported. Hemorrhagic conjunctivitis with palpebral edema has been reported rarely following instillation of ofloxacin ophthalmic solution.

While topical ciprofloxacin therapy has been associated with the development of a white granular or crystalline precipitate in the superficial portion of the corneal defect in some patients receiving the drug for bacterial keratitis, such precipitation has not been reported to date in patients with bacterial keratitis receiving ophthalmic ofloxacin. Although ophthalmologic abnormalities, including cataracts, have been reported with some other quinolones (e.g., pefloxacin) in both multiple-dose studies in humans and in long-term, high-dosage studies in animals, there has been no evidence of ofloxacin-induced cataracts in animal studies.

Otic Effects

Local reactions at the site of otic instillation have occurred in up to 16.8% of patients receiving ofloxacin for the treatment of otitis externa; such reactions also have occurred in patients in whom the drug was instilled into the ear canal for other indications. Earache has been reported in up to 1% of patients receiving the otic solution, and tinnitus, transient loss of hearing, otitis externa, otitis media, and otorrhagia also have been reported rarely.

Systemic Effects

Since systemic absorption may occur following topical application of ofloxacin to the eye or ear, the possibility of adverse systemic effects exists.

Stevens-Johnson syndrome that progressed to toxic epidermal necrosis has been reported in at least one patient receiving topical ophthalmic ofloxacin therapy. Although a causal relationship to the drug has not been definitely established, dizziness and nausea have been reported rarely following topical instillation of ofloxacin ophthalmic solution.

Following instillation of ofloxacin otic solution, taste perversion has been reported in 7% of patients with non-intact tympanic membranes. Pruritus has occurred in up to 4% of patients receiving ofloxacin otic solution. Adverse events reported in about 1% of patients receiving the otic drug include dizziness, vertigo, paraesthesia, or rash. Dermatitis, eczema, hypoesthesia, dyspepsia, diarrhea, nausea, vomiting, dry mouth, hot flashes, flushing, headache, fever, urticaria, abdominal pain, dysesthesia, hyperkinesia, tremor, halitosis, inflammation, pain, insomnia, fungal infection, cough, pharyngitis, rhinitis, sinusitis, hypertension, and tachycardia have been reported rarely in ofloxacin-treated patients.

Quinolones, including ofloxacin, have caused arthropathy in immature animals of various species. In young beagles, ofloxacin given in an oral dosage of 10 mg/kg daily for 7 days (110 times the maximum daily adult ophthalmic dosage) caused blisters and/or erosions in articular cartilage. However, administration of fluoroquinolone ophthalmic solutions (ciprofloxacin, ofloxacin) in the eye(s) of immature animals or ofloxacin 0.3% otic solution in the middle ear of young growing guinea pigs has not been reported to cause articular changes in weight-bearing joints. No evidence of structural or functional changes in the cochlea and no lesions in the ossicle were observed when ofloxacin 0.3% otic solution was administered to the middle ear in guinea pigs for 30 days.

For additional information on adverse systemic effects of ofloxacin, .

Precautions and Contraindications

Topical ofloxacin is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or any ingredient in the formulation.

Ofloxacin, like other quinolones, can cause serious, potentially fatal hypersensitivity reactions, occasionally following the initial systemic dose. Patients receiving ofloxacin should be advised of this possibility with the topically administered drug and instructed to discontinue the drug and contact their physician at the first sign of rash or any other sign of hypersensitivity.

The use of ofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the drug should be discontinued and other appropriate therapy instituted.

Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients receiving topical ophthalmic ofloxacin therapy.

When ofloxacin is used for the treatment of bacterial otic infections, cultures should be obtained to guide further treatment if the infection has not improved after 1 week of therapy. In addition, if otorrhea persists after completion of therapy or if 2 or more episodes of otorrhea occur within 6 months, further evaluation is indicated to exclude underlying conditions such as cholesteatoma, foreign body, or tumor.

Pediatric Precautions

Safety and efficacy of ofloxacin ophthalmic solution in children younger than 1 year of age have not been established.

Safety and efficacy of ofloxacin otic solution in children younger than 6 months of age with otitis externa have not been established. While ofloxacin otic solution has not been evaluated in children younger than 6 months of age, there are no known safety concerns or differences in disease process in these children to preclude administration of this preparation in children younger than 6 months of age. Safety and efficacy in children younger than 1 year of age with acute otitis media have not been established. Safety and efficacy of ofloxacin otic solution in children younger than 12 years of age with chronic suppurative otitis media have not been established. No changes in hearing function were observed on audiometric evaluation in a limited number of children treated with ofloxacin otic solution.

Mutagenicity and Carcinogenicity

Ofloxacin was not mutagenic in the Ames microbial bacterial mutagen test or in in vitro and in vivo cytogenic assays, including the sister chromatid exchange (Chinese hamster and human cell lines) assay, unscheduled DNA repair assay using human fibroblasts, dominant lethal assay, or mouse micronucleus assay. When ofloxacin was tested in the in vitro rat hepatocyte DNA repair assay, mouse lymphoma assay, and Rec-assay for DNA repair, results were positive, which may indicate a potential for primary DNA damage. However, other more sensitive tests, such as the V-79 mammalian cell assay, have not shown evidence of mutagenicity.

Studies have not been performed to date to evaluate the carcinogenic potential of ofloxacin.

Pregnancy, Fertility, and Lactation

Pregnancy

There are no adequate and controlled studies to date using ophthalmic or otic ofloxacin in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

While quinolones should not be used systemically in pregnant or nursing women because of serious bone toxicity observed in animals, there currently is no evidence of similar toxicity occurring when the drugs are administered topically to the eye or ear.

Reproductive studies in rats using oral ofloxacin dosages of 810 and 160 mg/kg daily (9000 and 1800 times the maximum recommended daily ophthalmic dosage), respectively, have not revealed evidence of teratogenicity. However, fetotoxicity (decreased fetal body weight and/or increased fetal mortality) did occur in rats and rabbits receiving such dosages. In rats given ofloxacin dosages of 810 mg/kg daily, retardation in the degree of ossification and minor skeletal variations, such as cervical ribs and shortened or absent 13th ribs, occurred. Perinatal and postnatal studies in rats given oral ofloxacin dosages up to 360 mg/kg daily (4000 times the maximum recommended daily ophthalmic dosage) revealed a decrease in food intake during gestation and an increase in food and water intake during lactation, but did not reveal evidence of adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the offspring.

Fertility

Studies in male and female rats using ofloxacin dosages up to 360 mg/kg daily (4000 times the maximum recommended daily ophthalmic dosage) indicate that the drug does not have an appreciable effect on fertility or reproductive performance.

Lactation

It is not known whether ofloxacin is distributed into milk following topical application to the eye or ear; however, ofloxacin is distributed into milk following systemic administration. Because of the potential for serious adverse effects of ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Drug Interactions

Specific drug interaction studies involving ofloxacin ophthalmic solution or otic solution and other drugs have not been conducted to date. However, since systemic absorption may occur following topical application of ofloxacin to the eye or ear, the possibility of drug interactions such as those reported with systemic administration of some quinolone anti-infectives (e.g., interactions with theophylline, caffeine, oral anticoagulants, cyclosporine) should be considered.

Pharmacokinetics

Absorption

The extent of ocular and systemic absorption of ofloxacin following topical application to the eye has not been fully elucidated; however, serum concentrations achieved following such application to uninflamed eyes are minimal relative to those produced by usual oral or parenteral doses of the drug. Following topical application to the eye of 1 drop of a 0.3% solution of ofloxacin 4 times daily for 10.5 days in healthy women, drug concentrations measured in tear film within 40 minutes after the final dose ranged from 5.7-31 mcg/g. In this study, ofloxacin concentrations in tear film showed considerable interindividual variation but averaged 9.2 mcg/g 4 hours after application of the next to last dose. Following single-dose topical application to the eye of 50 mcL of a 0.3% solution of ofloxacin (150 mcg) in rabbits, drug concentrations in tear film exceeded 2 mg/g 1 minute after the dose; drug concentrations declined rapidly and averaged 10 mcg/g or less 40 minutes after the dose.

Ofloxacin is absorbed through the cornea into aqueous humor following topical application to the eye; absorption is enhanced in the presence of ocular inflammation and/or epithelial defects. In rabbits, topical application of 1 drop of a 0.3% solution of ofloxacin every 30 minutes for 12 hours in eyes with intact epithelium produced aqueous humor drug concentrations averaging 1.2 mcg/mL within 1 hour of the final dose; in eyes with ocular epithelial defects, concurrently obtained ofloxacin concentrations in aqueous humor averaged 2.2 mcg/mL. Following topical application to the eye of 1 drop of ofloxacin 0.3% every hour for 8 doses daily for 7 days in rabbits, drug concentrations in aqueous humor within 1 hour of the final dose averaged 0.88 mcg/mL.On day 7, distribution of the drug in aqueous humor of those rabbits with ocular epithelial defects induced on day 1 generally was similar to that observed in normal eyes, indicating restoration of epithelium and corneal ulcer healing.

Following topical application to the eye of 2 drops of a 0.3% solution of ofloxacin every 30 minutes beginning 4 hours before surgery in patients undergoing keratoplasty, corneal tissue, aqueous humor, and vitreous humor concentrations at the time of surgery averaged 4.4, 1.3, and 0.4 mcg/mL, respectively. Following topical application to the eye of 1 drop of a 0.3% solution of ofloxacin every 20 minutes for 1 hour (4 doses) in patients undergoing keratoplasty, corneal tissue concentration determined in cornea harvested within 1 hour after the last dose of ofloxacin averaged 0.81 mcg/g (range: 0.32-3.73 mcg/g).

Some systemic absorption of ofloxacin occurs following topical application to the eyes, although use of ofloxacin ophthalmic solution to date has been associated with a low potential for causing systemic effects. Ofloxacin was detectable in serum 10 minutes after ocular instillation of 1 drop of a 0.3% solution in healthy women. However, following ocular instillation to the eyes of 1 drop of ofloxacin 4 times daily for 10.5 days in these women, serum ofloxacin concentrations 10 minutes after the first dose on day 11 averaged only 1.3 ng/mL. Peak serum drug concentrations increased from 1.1 ng/mL on day 1 to 1.9 ng/mL on day 11, indicating some systemic accumulation of ofloxacin following multiple doses. In contrast, peak serum concentrations following administration of a single 300-mg oral dose of ofloxacin generally average 2.4-4.6 mcg/mL.

The extent of otic and systemic absorption of ofloxacin following topical application to the ear has not been fully elucidated; however, serum concentrations achieved following such application are minimal relative to those produced by usual oral or parenteral doses of the drug.While topical application of ofloxacin to the ear canal is associated with minimal penetration into the middle ear when the tympanic membrane is intact, penetration is enhanced in the presence of a perforated tympanic membrane. Following topical application of ofloxacin 0.3% otic solution in adults with perforated tympanic membranes, drug concentrations in middle ear mucosa showed considerable interindividual variation and ranged from undetectable to 602 mcg/g. Following topical application of ofloxacin 0.3% otic solution in patients with perforated tympanic membranes, drug concentrations in otorrhea ranged from 389-2850 mcg/g 30 minutes after the dose. However, concentration of ofloxacin in otorrhea may not reflect exposure of the middle ear to the drug.

Some systemic absorption of ofloxacin occurs following topical application to the ear. Following otic administration of a single dose of ofloxacin 0.3% otic solution (10 drops, 0.5 mL, 1.5 mg of ofloxacin) in adults with tympanostomy tubes with or without otorrhea, serum ofloxacin concentrations averaged 4.1 or 5.4 ng/mL, respectively. Following administration of ofloxacin 0.3% otic solution in adults with perforated tympanic membranes, a peak serum concentration of 10 ng/mL was reported.

Distribution

Distribution of ofloxacin into human ocular tissues and fluids following topical ophthalmic or systemic administration has not been fully characterized to date.

Ofloxacin is widely distributed into body tissues and fluids following oral or IV administration. Current information on the distribution of ofloxacin into ocular tissues and fluids following systemic administration of the drug is based principally on studies in patients with uninflamed and/or uninfected eyes; distribution is likely to be greater in the presence of inflammation or infection because of disruption of the blood-ocular barrier. Following oral or IV administration of ofloxacin in patients undergoing cataract extraction, peak drug concentrations in aqueous humor generally have averaged 20-44% of concurrent serum concentrations. Limited data suggest that drug concentrations in vitreous humor following systemic administration of other fluoroquinolones (e.g., ciprofloxacin) are similar to those in aqueous humor.

Ofloxacin is 20-32% bound to serum proteins in vitro.

Ofloxacin crosses the placenta and is distributed into amniotic fluid in humans; the drug also is distributed into milk.

Elimination

The metabolic fate and elimination characteristics of ofloxacin following topical application to the eye have not been fully elucidated. Following ocular instillation of 1 drop of ofloxacin 0.3% 4 times daily for 12 doses in healthy individuals, the elimination half-life of drug in tear film was approximately 226 minutes. In a study in rabbits, the terminal elimination half-life of ofloxacin in tear film following topical application to the eye was approximately 210 minutes. In adults with normal renal function, the serum elimination half-life of ofloxacin in the terminal phase averages 4-8 hours.

Systemically absorbed ofloxacin undergoes limited biotransformation; less than 10% of a single dose of ofloxacin is metabolized. Ofloxacin and its metabolites are excreted in urine and feces. Ofloxacin is excreted principally in urine as unchanged drug; less than 5% of a single systemic dose is excreted in urine as metabolites. Approximately 4-8% of a systemic dose is excreted in feces.

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