CILOXAN

INDICATIONS AND USAGE: CILOXAN ® (ciprofloxacin ophthalmic ointment) 0.3% 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

DOSAGE AND ADMINISTRATION: Apply a ½ inch ribbon into the conjunctival sac three times a day on the first two days, then apply a ½ inch ribbon two times a day for the next five days.

WARNINGS: FOR EYE USE ONLY NOT FOR INJECTION INTO THE EYE Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

CONTRAINDICATIONS: 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.

Drug Interactions: 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.

Pregnancy: 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 ophthalmic ointment) 0.3% 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 ophthalmic ointment) 0.3% is administered to a nursing mother.

ADVERSE REACTIONS: The following adverse reactions (incidences) were reported in 2% of the patients in clinical studies for CILOXAN ® (ciprofloxacin ophthalmic ointment) 0.3%: discomfort and 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, 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.