Rocipro 0.003

INDICATIONS

Ciprofloxacin 0.3% ophthalmic solution is indicated for the treatment of corneal ulcers, conjunctivitis, and blepharitis, which are caused by susceptible strains of bacteria.

PHARMACOLOGY

Ciprofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive organisms. Ciprofloxacin is bactericidal and acts by inhibiting the A subunits of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA.

DOSAGE & ADMINISTRATION

For Corneal Ulcers: Instill 2 drops into the affected eye every 15 minutes for the first six hours and then 2 drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops into the affected eye hourly. On the third through the fourteenth day, place 2 drops into the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.Bacterial Conjunctivitis/Blepharitis: Instill 1 drop to the conjunctival sac(s) every two hours for two days and 1 drop every four hours for the next five days.Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.

INTERACTION

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 have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

SIDE EFFECTS

The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients. Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

PREGNANCY & LACTATION

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PRECAUTIONS & WARNINGS

General: As with other anti-infective, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and initiate alternative therapy. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

THERAPEUTIC CLASS

Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs

STORAGE CONDITIONS

Store at room temperature, protect from light. It is desirable that the contents should not be used more than one month after first opening of the bottle.