Corneal Ulcers:
Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.

Conjunctivitis:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus (Viridans group), Streptococcus pneumoniae, Haemophilus influenzae.

CILOXAN (Ciprofloxacin Hydrochloride) Ophthalmic Ointment is indicated for the treatment of the following infections of the eye and its adnexae when caused by susceptible strains of the designated bacteria.

Corneal Ulcers:
Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis.

Anaphylactic reactions following the first dose, have been reported in patients receiving therapy with quinolones by systemic administration. 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 reaction. Anaphylactic reactions may require epinephrine and other emergency measures. Ciprofloxacin should be discontinued at the first sign of hypersensitivity or allergy and the patient monitored until the risk of anaphylaxis is no longer present. Severe hypersensitivity reactions characterized by rash, fever, eosinophilia, jaundice, and hepatic necrosis with fatal outcome have been reported rarely (less than one per million prescriptions) in patients receiving systemically administered ciprofloxacin along with other drugs. One report exists of anaphylaxis in a patient treated with topical ciprofloxacin concomitantly with several other antibiotics and medications. The possibility that these reactions were related to ciprofloxacin cannot be excluded. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

In clinical studies of patients with bacterial corneal ulcer, a white crystalline precipitate located in the superficial portion of the corneal defect was observed in 29 (18.8%) out of 154 patients administered CILOXAN Ophthalmic Solution and in 32 (12.6%) of 253 patients administered CILOXAN Ophthalmic Ointment. The onset of the precipitate was within 24 hours to 7 days (solution) and 13 days (ointment) after starting therapy. In 16 patients administered CILOXAN Ophthalmic Solution, resolution of the precipitate was seen in 1 to 8 days (seven within the first 24-72 hours), in four patients, resolution was noted in 10-13 days. In one patient, the precipitate was immediately irrigated out upon its appearance.

In six patients, exact resolution days were unavailable, however, at follow-up examinations 18-44 days after onset of the event, complete resolution of the precipitate was noted. In two patients, outcome information was unavailable. The presence of the white precipitate did not preclude continued use of CILOXAN (Ciprofloxacin) Ophthalmic Solution or Ointment, nor did it adversely affect the clinical course of the ulcer or visual outcome. A literature report exists of a single case of ciprofloxacin-associated dense precipitate apparently interfering with re-epithelialization.

Dosage regimens involving both solution and ointment formulations of ciprofloxacin 0.3% have not been studied. A controlled study of the efficacy and safety of ciprofloxacin ointment versus ciprofloxacin solution 0.3% has not been conducted.

In patients with large (> 4mm) and/or deep stromal ulcers, the clinical success rate was lower for both ciprofloxacin and standard (fortified antibiotics) therapy.

Drug Interactions:
Specific drug interaction studies have not been conducted with ClLOXAN Ophthalmic Solution or Ointment. 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 cyclosporin concomitantly.

Pregnancy:
There are no adequate and well controlled studies of CILOXAN (Ciprofloxacin Hydrochloride) Ophthalmic Solution or Ointment in pregnant women. This drug should be used in pregnant women only if in the physician's opinion, the benefit clearly outweighs any potential unknown risks.

Reproduction studies have been performed in rats and mice at doses up to 6 times the usual daily human 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 in rabbits, at doses up to 20 mg/kg, no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.

Nursing Mothers:
It is not known whether topically applied CILOXAN Ophthalmic Solution or Ointment is excreted in human milk, however, it is known that orally administered ciprofloxacin is excreted in milk of lactating rats and that other drugs of this class are excreted in human milk. For this reason, and because of the potential for serious adverse reactions from ciprofloxacin in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.

Pediatric Use:
Safety and efficacy of CILOXAN ophthalmic solution or ointment in children less than one year of age have not been demonstrated. CILOXAN (Ciprofloxacin Hydrochloride) Ophthalmic Solution has been used in 123 children between the ages of one and twelve years and CILOXAN (Ciprofloxacin Hydrochloride) Ophthalmic Ointment has been used in 182 children between the ages of one and twelve years. No serious adverse event was reported in these patients.

Ciprofloxacin and quinolone-related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. Topical ocular administration of ciprofloxacin to immature animals (Beagle dogs) did not cause arthropathy or demonstrate any articular lesions and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.