Product Description.:
CILOXAN? (ciprofloxacin hydrochloride 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.
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 contains:
Active: Ciprofloxacin HCl 3.33 mg equivalent to 3 mg base.
Inactives: Mineral Oil, White Petrolatum.
INDICATIONS
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
DOSAGE AND ADMINISTRATION
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.
SIDE EFFECTS
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.
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.
