OCUFLOX

What it is

OCUFLOX eye drops contain 3 mg/mL ofloxacin. They are supplied as an eye drops solution. Ofloxacin is a third generation fluorinated 4-quinolone having broad spectrum in vitro bactericidal activity against certain aerobic gram-positive, gram-negative and some anaerobic bacteria.

Approved indications

— Corneal ulcers (bacterial keratitis) caused by ofloxacin sensitive organisms in adults. — Severe bacterial conjunctivitis caused by ofloxacin sensitive organisms in adults.

Dosing overview

For corneal ulcers: on days 1 and 2, instil one to two drops into the affected eye(s) every 30 minutes while awake and further drops during the night four hours after retiring and again two hours after this; on days 3 to 7, instil one to two drops every hour while awake; and from day 7 to completion of treatment (usually within 21 days), instil one to two drops four times daily until the ulcer is completely healed. For bacterial conjunctivitis, the dosage recommendation is one drop every four hours for the first two days, and then one drop every six hours into the affected eye(s) for up to eight days. Dosage should not normally be continued for more than 10 days without an ophthalmic review.

Key safety warnings

The preservative in OCUFLOX eye drops, benzalkonium chloride, may be absorbed by and cause discoloration of soft contact lenses; OCUFLOX eye drops should not be administered while wearing soft contact lenses, and patients should remove contact lenses prior to administration and wait at least 15 minutes following administration before reinserting them. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin; some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching, and serious, acute hypersensitivity reactions may require immediate emergency treatment. There have been rare reports of Stevens-Johnson syndrome and toxic epidermal necrolysis reported in association with topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Quinolones induce phototoxicity in a number of in vitro and in vivo animal models and have the potential to produce phototoxic reactions in sensitive individuals following systemic administration; patients taking ofloxacin should avoid direct exposure to sunlight or artificial ultraviolet light, and therapy should be discontinued if photosensitivity occurs. Corneal precipitates and corneal perforation in patients with pre-existing corneal epithelial defect/corneal ulcers have been reported during treatment with topical ophthalmic ofloxacin.

Contraindications

OCUFLOX eye drops are contraindicated in patients sensitive to ofloxacin or any other component of the solution. A history of hypersensitivity to other quinolone anti-infectives, including nalidixic acid, may also contraindicate the use of OCUFLOX eye drops.

PBS listing

OCUFLOX eye drops 3 mg per mL, 5 mL are listed on the PBS as 2 items with authority required restriction; the ex-manufacturer price is A$7.38.

Regulatory history

OCUFLOX ofloxacin 3 mg/mL sterile ophthalmic solution was first listed on the ARTG on 18 February 1994 under registration number 47485. The medicine received its first approval on 2 December 1997.