Indications
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
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.
Warnings and precautions
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.
Interactions
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 and breastfeeding
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.
At a glance
- Brand name
- Ciloxan
- Active substance
- ciprofloxacin hydrochloride
- Route
- Eye
- Dosage form
- Ointment
- Applicant
- Sandoz
- Status
- Prescription
- FDA approval
- 30 Mar 1998
- Application
- NDA020369-001



