CILOXAN® (ciprofloxacin hcl ophthalmic ointment) Ophthalmic Ointment is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7- (1-piperazinyl)-3-quinolinecarboxylic acid. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 385.82. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each gram ot CILOXAN Ophthalmic Ointment (ciprofloxacin hcl ophthalmic ointment) contains: Active: Ciprofloxacin HCl 3.33 mg equivalent to 3 mg base.
Inactives: Mineral Oil, White Petrolatum.

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The following adverse reactions (incidences) were reported in 2% of the patients in clinical studies for CILOXAN Ophthalmic Ointment: discomfort, keratopathy. Other reactions associated with ciprofloxacin therapy occurring in less than 1% of patients included allergic reactions, blurred vision, corneal staining, decreased visual acuity, dry eye, edema, epitheliopathy, eye pain, foreign body sensation, hyperemia, irritation, keratoconjunctivitis, keratopathy, lid erythema, lid margin hyperemia, photophobia, pruritus, and tearing. Systemic adverse reactions related to ciprofloxacin therapy occurred at an incidence below 1% and included dermatitis, nausea and taste perversion. Read the Ciloxan Ophthalmic Ointment (ciprofloxacin hcl ophthalmic ointment) Side Effects Center for a complete guide to possible side effectsLearn More »

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Apply a 1/2" ribbon into the conjunctival sac three times a day on the first two days, then apply a 1/2" ribbon two times a day for the next five days.

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Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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CILOXAN Ophthalmic Ointment is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below: Gram-Positive: Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus Viridans Group Gram-Negative: Haemophilus influenzae

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A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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Sterile ophthalmic ointment: 3.5 g ophthalmic ointment tube. 3.5 g NDC 0065-0654-35 Storage: Store at 36° F to 77° F (2° C to 25° C). Rx Only Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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General As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. Ophthalmic ointments may retard corneal healing and cause visual blurring. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Information For Patients See PATIENT INFORMATION section. Drug Interactions See DRUG INTERACTIONS section. Carcinogenesis, Mutagenesis, Impairment of Fertility Eight in vitro mutagenicity tests have been conducted with ciprofloxacin and the test results are listed below: Salmonella/Microsome Test (Negative)
E.coli DNA Repair Assay (Negative)
Mouse Lymphoma Cell Forward Mutation Assay (Positive)
Chinese Hamster V79 Cell HGPRT Test (Negative)
Syrian Hamster Embryo Cell Transformation Assay (Negative)
Saccharomyces cerevisiae Point Mutation Assay (Negative)
Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
Rat Hepatocyte DNA Repair Assay (Positive) Thus, two of the eight tests were positive, but the results of the following three in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay
Micronucleus Test (Mice)
Dominant Lethal Test (Mice) Long-term carcinogenicity studies in mice and rats have been completed. After daily oral dosing for up to two years, there is no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. Pregnancy Pregnancy Category C. Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose. After intravenous administration, at doses up to 20 mg/kg no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. CILOXAN® (ciprofloxacin hcl ophthalmic ointment) Ophthalmic Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether topically applied ciprofloxacin is excreted in human milk. However, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when CILOXAN® (ciprofloxacin hcl ophthalmic ointment) Ophthalmic Ointment is administered to a nursing mother. Pediatric Use Safety and effectiveness of CILOXAN Ophthalmic Ointment (ciprofloxacin hcl ophthalmic ointment) 0.3% in pediatric patients below the age of two years have not been established. Although ciprofloxacin and other quinolones may cause arthropathy in immature Beagle dogs after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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