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ofloxacin 0.3% eye drops generic ocuflox

Out of Stock Manufacturer AKORN INC. 17478071311
Out of Stock

Uses

Bacterial Ophthalmic Infections

Conjunctivitis

Ofloxacin 0.3% ophthalmic solution is used for the topical treatment of bacterial conjunctivitis caused by susceptible Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Haemophilus influenzae, Enterobacter cloacae, Proteus mirabilis, or Pseudomonas aeruginosa.

Although mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment, topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications. Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended; however, indiscriminate use of topical anti-infectives should be avoided. In vitro staining and/or cultures of conjunctival material may be indicated in the management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.

Clinical Experience

Results from several controlled studies indicate that ofloxacin 0.3% ophthalmic solution is more effective than placebo (vehicle) and as effective as gentamicin 0.3% or tobramycin 0.3% ophthalmic solution in the treatment of acute bacterial conjunctivitis caused by various gram-positive and/or -negative bacteria. 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.

In a randomized, double-masked, multicenter study that included 63 patients with conjunctivitis and positive conjunctival cultures, clinical improvement was reported after 2 days in 86% of those treated with ofloxacin 0.3% ophthalmic solution and in 72% of those treated with placebo. The microbiologic eradication rate after 2 days of treatment with ofloxacin or placebo was 65 or 25%, respectively.

Keratitis

Ofloxacin 0.3% ophthalmic solution is used for the topical treatment of bacterial keratitis (corneal ulcers) caused by susceptible S. aureus, S. epidermidis, S. pneumoniae, Ps. aeruginosa, Serratia marcescens, or Propionibacterium acnes. Ofloxacin ophthalmic solution is designated an orphan drug by FDA for the treatment of bacterial corneal ulcers.

Because many forms of bacterial keratitis are associated with subsequent loss of vision as the result of corneal scarring or topographic irregularities and because untreated or severe bacterial keratitis may result in perforation of the cornea with the potential for endophthalmitis and possible loss of the eye, optimal management involves rapid evaluation and diagnosis, timely initiation of treatment, and appropriate follow-up. Treatment of community-acquired bacterial keratitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended. Subconjunctival therapy with an appropriate anti-infective may be necessary if scleral spread or perforation is imminent. In vitro staining and/or cultures are indicated in the management of keratitis involving corneal infiltrates that are central, large, and extending to the middle to deep stroma or when keratitis is chronic or unresponsive to treatment with a broad-spectrum topical anti-infective.

Clinical Experience

Results from a randomized, double-masked, multicenter study in 140 patients with corneal ulcers and positive cultures indicate that ofloxacin 0.3% 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, clinical cure (i.e., complete reepithelialization and no progression of the infiltrate on 2 consecutive visits) was attained in 82% of patients treated with ofloxacin 0.3% ophthalmic solution and in 80% of those treated with the topical regimen of tobramycin and cefazolin. While nonprogression of infiltrate usually occurred about 3 days after initiating therapy with either regimen, the median time to clinical cure was 11 or 10 days in patients treated with 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.

Bacterial Otic Infections

Otitis Externa

Ofloxacin 0.3% otic solution is used for the topical treatment of otitis externa caused by susceptible S. aureus, Escherichia coli, or Ps. aeruginosa. Results of comparative studies in adults and children with otitis externa indicate that ofloxacin otic solution is as effective as fixed-combination neomycin, polymyxin B, and hydrocortisone otic solution based on clinical and microbiologic response.

Diffuse, uncomplicated acute otitis externa in otherwise healthy patients usually should be treated initially with topical therapy (e.g., otic anti-infective or antiseptic with or without an otic corticosteroid). Topical therapy should be supplemented with systemic anti-infective therapy if the patient has a medical condition that could impair host defenses (e.g., diabetes mellitus, human immunodeficiency virus [HIV] infection) or if the infection has spread into the pinna or skin of the neck or face, or into deeper tissues such as occurs with malignant otitis externa. Malignant otitis externa is an invasive, potentially life-threatening infection, especially in immunocompromised patients, and requires prompt diagnosis and long-term treatment with systemic anti-infectives.

Acute Otitis Media

Ofloxacin 0.3% otic solution is used topically for the treatment of acute otitis media caused by susceptible S. aureus, S. pneumoniae, H. influenzae, Moraxella catarrhalis, or Ps. aeruginosa in patients with tympanostomy tubes.

Chronic Suppurative Otitis Media

Ofloxacin 0.3% otic solution is used topically for the treatment of chronic suppurative otitis media (CSOM) caused by susceptible S. aureus, P. mirabilis, or Ps. aeruginosa in patients with perforated tympanic membranes. Because commercially available ofloxacin otic solution is sterile, unlike the fixed-combination ciprofloxacin hydrochloride and hydrocortisone otic suspension (which is nonsterile), ofloxacin otic solution can be used for the treatment of otic infections even when the tympanic membrane is perforated.

Clinical Experience

In an open label study in patients with chronic suppurative otitis media and a chronically perforated tympanic membrane in the infected ear(s), treatment with ofloxacin 0.3% 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.

Systemic Uses

For systemic uses of ofloxacin,

Dosage and Administration

Administration

Ophthalmic Administration

Ofloxacin is applied topically to the eye as a 0.3% ophthalmic solution.

Ofloxacin ophthalmic solution is for topical ophthalmic use only; the ophthalmic solution should not be injected subconjunctivally or directly into the anterior chamber of the eye.

Care should be taken to avoid contaminating the applicator tip with material from the eye, fingers, or other source.

Otic Administration

Ofloxacin is instilled topically into the ear canal as a 0.3% otic solution.

Ofloxacin otic solution is for topical otic use only; the otic solution is not for ophthalmic use or injection.

To avoid dizziness that may result from instilling a cold preparation into the ear canal, the container of otic solution should be warmed in the hands for 1-2 minutes before use.

The patient should lie with the affected ear upward. The appropriate amount of otic solution should be instilled into the ear; this position should be maintained for 5 minutes to facilitate penetration of the solution into the ear canal. When treating acute otitis media or chronic suppurative otitis media, the tragus of the ear should be pumped 4 times by pushing inward to facilitate penetration of the solution into the middle ear. The procedure should be repeated for the opposite ear if necessary.

Care should be taken to avoid contaminating the applicator tip with material from the fingers or other source.

Dosage

Bacterial Ophthalmic Infections

Conjunctivitis

For the topical treatment of bacterial conjunctivitis in adults and children 1 year of age and older, 1 or 2 drops of ofloxacin 0.3% ophthalmic solution should be instilled in the affected eye(s) every 2-4 hours on days 1 and 2, then 1 or 2 drops of the ophthalmic solution should be instilled 4 times daily on days 3 through 7.

The usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5-10 days; some experts state that 5-7 days of such treatment usually is adequate for mild bacterial conjunctivitis.

Keratitis

For the topical treatment of bacterial keratitis (corneal ulcers) in adults and children 1 year of age and older, 1 or 2 drops of ofloxacin 0.3% ophthalmic solution should be instilled in the affected eye(s) every 30 minutes while awake and at approximately 4 and 6 hours after retiring on days 1 and 2. On days 3 through 7 or 9, 1 or 2 drops of the ophthalmic solution should be instilled in the affected eye(s) every hour while awake; then, 1 or 2 drops of the solution should be instilled 4 times daily until treatment completion.

Some experts state that the initial regimen should be reevaluated and modified if there is no improvement or stabilization of keratitis within 48 hours after initiation of treatment.

Bacterial Otic Infections

Otitis Externa

For the topical treatment of bacterial otitis externa in children 6 months to 13 years of age, 5 drops of ofloxacin 0.3% otic solution (0.25 mL, 0.75 mg of ofloxacin) should be instilled into the canal of the affected ear(s) once daily for 7 days.

For the topical treatment of bacterial otitis externa in adults and adolescents 13 years of age or older, 10 drops of ofloxacin 0.3% otic solution (0.5 mL, 1.5 mg of ofloxacin) should be instilled into the canal of the affected ear(s) once daily for 7 days.

The optimal duration of topical therapy for the treatment of acute otitis externa has not been determined, but 7-10 days is usually recommended. Some experts state that appropriate treatment of acute otitis externa should result in improvement in symptoms (otalgia, itching, fullness) within 48-72 hours, although resolution of symptoms may take up to 2 weeks. The manufacturer states that if there is no improvement in otitis externa after 1 week of treatment, cultures should be used to help guide further treatment.(See Precautions Related to Otic Administration under Cautions: Precautions and Contraindications.)

Acute Otitis Media

For the topical treatment of acute otitis media in pediatric patients 1-12 years of age with tympanostomy tubes, 5 drops of ofloxacin 0.3% otic solution (0.25 mL, 0.75 mg of ofloxacin) should be instilled into the canal of the affected ear(s) twice daily for 10 days.

Chronic Suppurative Otitis Media

For the topical treatment of chronic suppurative otitis media in adults and pediatric patients 12 years of age or older with perforated tympanic membranes, 10 drops of ofloxacin 0.3% otic solution (0.5 mL, 1.5 mg of ofloxacin) should be instilled into the canal of the affected ear(s) twice daily for 14 days.

Cautions

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

Ophthalmic Administration

Local Effects

The most frequent adverse effects following topical application of ofloxacin 0.3% ophthalmic solution in the eye are transient ocular burning or discomfort. Stinging, redness, pruritus, chemical conjunctivitis/keratitis, foreign body sensation, blurred vision, ocular/periocular/facial edema, eye pain, photophobia, tearing, and dryness also have been reported.

Hemorrhagic conjunctivitis with palpebral edema has been reported rarely following topical application of ofloxacin ophthalmic solution.

Systemic Effects

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

Although a causal relationship to the drug has not been definitely established, dizziness and nausea have been reported rarely following topical application of ofloxacin ophthalmic solution.

Stevens-Johnson syndrome that progressed to toxic epidermal necrosis has been reported in at least one patient receiving topical ofloxacin ophthalmic solution.

Otic Administration

Local Effects

Local reactions at the site of otic instillation have occurred in up to 17% of patients receiving ofloxacin 0.3% otic solution 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 topical 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 ear, the possibility of adverse systemic effects exists.

Following otic instillation of ofloxacin 0.3% 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, paresthesia, 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 patients receiving ofloxacin otic solution.

For additional information on adverse effects of ofloxacin, .

Precautions and Contraindications

Ofloxacin 0.3% ophthalmic solution and ofloxacin 0.3% otic solution are contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or any ingredient in the formulation.

Serious and occasionally fatal hypersensitivity reactions have been reported rarely in patients receiving systemic quinolones, including systemic ofloxacin, and these reactions have been reported following the initial systemic dose. Patients receiving ofloxacin ophthalmic or otic preparations should be advised that hypersensitivity reactions have been reported with systemic ofloxacin and instructed to immediately discontinue the drug and contact a clinician at the first sign of rash or allergic reaction. Serious acute hypersensitivity reactions may require immediate emergency treatment; oxygen and airway management should be administered as clinically indicated.

As with other anti-infectives, prolonged 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.

Precautions Related to Ophthalmic Administration

When ofloxacin ophthalmic solution is used for the topical treatment of bacterial ophthalmic infections, examination with slit-lamp biomicroscopy and, when appropriate, fluorescein staining should be performed as clinically indicated.

Precautions Related to Otic Administration

When ofloxacin otic solution is used for the topical treatment of bacterial otic infections, cultures should be obtained to guide further treatment if the infection has not improved after 1 week of therapy.

If otorrhea persists after completion of topical ofloxacin 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

Ofloxacin 0.3% ophthalmic solution: Safety and efficacy have not been established in children younger than 1 year of age.

Ofloxacin 0.3% otic solution: Safety and efficacy for the treatment of otitis externa with intact tympanic membrane have not been established in children younger than 6 months of age. The manufacturer states that, although data are not available regarding use of ofloxacin otic solution in children younger than 6 months of age, there are no known safety concerns or differences in disease process in children in this age group that would preclude use of the otic preparation in children younger than 6 months of age.

Ofloxacin 0.3% otic solution: Safety and efficacy for the treatment of acute otitis media have not been established in children younger than 1 year of age. Safety and efficacy for the treatment of chronic suppurative otitis media have not been established in children younger than 12 years of age.

Quinolones, including ofloxacin, have caused arthropathy in immature animals of various species following oral administration. 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, topical administration of ofloxacin ophthalmic solution 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 arthropathy. There is no evidence that the ophthalmic solution has any effect on weight-bearing joints. There was no evidence of structural or functional changes in the cochlea and no lesions in the ossicle when ofloxacin 0.3% otic solution was administered to the middle ear in guinea pigs for 30 days.

No changes in hearing function were observed on audiometric evaluation in a limited number of children treated with ofloxacin otic solution.

Geriatric Precautions

No overall differences in safety and efficacy of ofloxacin 0.3% ophthalmic solution have been observed between geriatric and younger adults.

Mutagenicity and Carcinogenicity

Ofloxacin was not mutagenic in the Ames microbial bacterial mutagen test or 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 ofloxacin 0.3% ophthalmic solution or ofloxacin 0.3% otic solution in pregnant women, and these preparations should be used during pregnancy only when potential benefits justify possible risks to the fetus.

Reproductive studies in rats and rabbits using oral ofloxacin dosages as high as 810 and 160 mg/kg daily (equivalent to 9000 and 1800 times the maximum recommended daily ophthalmic dosage, respectively) did not reveal evidence of teratogenicity. However, embryocidal effects were reported in rats and rabbits receiving such dosages. Decreased fetal body weight and retardation in the degree of ossification and minor skeletal variations, such as cervical ribs and shortened or absent 13th ribs, were reported in the rats; increased fetal mortality was reported in the rabbits. 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 oral 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 oral 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 have not been performed using ofloxacin ophthalmic or otic preparations. 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

Ophthalmic Administration

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 doses of the drug. Following topical application to the eye of 1 drop of ofloxacin 0.3% ophthalmic solution 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.

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 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.

Otic Administration

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 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 topical instillation 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 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 following oral administration.

It is not known whether ofloxacin is distributed into milk following topical ophthalmic or otic administration; the drug is distributed into milk following oral administration.

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 systemic 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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