1/2 inch ribbon in the conjunctival sac TID x 2 days, then 1/2 inch ribbon BID x 5 days.
OFF-LABELNot in the FDA label for this product
Bacterial keratitis
Trial regimen: every 1 to 2 hours for 2 days, then every 4 hours for 12 days. Ribbon length was not reported.
Nonrandomized · n=253
Prospective multicenter study with a nonrandomized concurrent comparison, 253 treated and 145 culture-positive evaluable: clinical success with initial treatment in 93% (135 of 145) versus 70% (28 of 40) among eligible culture-positive patients not enrolled and given conventional therapy. A transient white crystalline corneal precipitate occurred in 13% (32 of 253), shown by liquid chromatography in two cases to be the drug. PubMed indexes this as a clinical trial and comparative study, not a randomized controlled trial, so the comparison group is not a randomized control arm.
Hypersensitivity to ciprofloxacin or any other component of this product.
A history of hypersensitivity to other quinolones may also contraindicate use.
Available Forms
Ophthalmic ointment, 3.5 g tube, 0.3% (3 mg ciprofloxacin base per gram)
Mechanism of Action
Fluoroquinolone; bactericidal through interference with DNA gyrase, the enzyme needed for synthesis of bacterial DNA, with additional inhibition of topoisomerase IV, the primary quinolone target in susceptible Staphylococcus aureus. In vitro resistance develops slowly by multistep mutation, and there is no cross-reaction with beta-lactams or aminoglycosides, so organisms resistant to those agents may remain susceptible.
Warnings & Precautions
Topical ophthalmic use only: Not for injection into the eye.
Systemic quinolone anaphylaxis: Serious and occasionally fatal hypersensitivity reactions, some after the first dose, have been reported in patients on systemic quinolone therapy, with cardiovascular collapse, loss of consciousness, pharyngeal or facial edema, dyspnea, urticaria and itching; only a few of those patients had any prior history of hypersensitivity reactions.
Corneal healing delay: Ophthalmic ointments may retard corneal healing and cause visual blurring.
Nonsusceptible organism overgrowth: Prolonged use may allow overgrowth of nonsusceptible organisms including fungi; start appropriate therapy if superinfection occurs.
Hypersensitivity rash: Discontinue at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
Corneal precipitate risk: A white crystalline corneal deposit developed in 13% (32 of 253) of patients given the 0.3% ointment for bacterial keratitis, an off-label use dosed far more frequently; deposits were transient and caused no serious adverse event.
Contact lens wear: Not appropriate while signs and symptoms of bacterial conjunctivitis are present.
Common Side Effects
Ocular, 2%: Discomfort, keratopathy.
Ocular, under 1%: Blurred vision, corneal staining, epitheliopathy, decreased visual acuity, keratoconjunctivitis, dry eye, eye pain, foreign body sensation, hyperemia, lid margin hyperemia, lid erythema, photophobia, allergic reactions.
Systemic, under 1%: Dermatitis, nausea, taste perversion.
Pregnancy & Lactation
Pregnancy: Oral reproduction studies in rats and mice at up to 6 times the usual daily human oral dose showed no impaired fertility and no fetal harm; oral dosing in rabbits at 30 and 100 mg/kg caused gastrointestinal disturbance, maternal weight loss and increased abortion without teratogenicity, and intravenous dosing up to 20 mg/kg produced no maternal toxicity, embryotoxicity or teratogenicity. No adequate and well controlled studies in pregnant women; use only if the potential benefit justifies the potential fetal risk.
Lactation: Excretion of topically applied drug in human milk is unknown; oral dosing is excreted in the milk of lactating rats and has been reported in human breast milk after a single 500 mg dose.
Pediatric Use
Safety and effectiveness not established below age 2.