Ocuflox®

GoodRx

Ofloxacin 0.3% · ophthalmic solution

Antibiotic

Approved uses

Bacterial conjunctivitis

1 or 2 drops q2h to q4h on days 1 and 2, then 1 or 2 drops QID on days 3 through 7.

Bacterial corneal ulcer

Days 1 and 2: 1 or 2 drops q30min while awake, plus 1 or 2 drops on waking at about 4 and 6 hours after retiring. Days 3 through 7 to 9: 1 or 2 drops hourly while awake. Days 7 to 9 through completion: 1 or 2 drops QID.

FDA label, Dosage and Administration and Clinical Pharmacology, Clinical Studies, Corneal Ulcers; O'Brien TP, Maguire MG, Fink NE, Alfonso E, McDonnell P. Efficacy of ofloxacin vs cefazolin and tobramycin in the therapy for bacterial keratitis. Report from the Bacterial Keratitis Study Research Group. Arch Ophthalmol. 1995;113(10):1257-1265.

Contraindications

History of hypersensitivity to ofloxacin, to other quinolones, or to any component of the formulation.

Available Forms

5 mL in a 10 mL dropper bottle, 0.3% solution, 3 mg ofloxacin per mL

Mechanism of Action

Fluoroquinolone; bactericidal at concentrations equal to or slightly above inhibitory concentrations, thought to act by inhibiting DNA gyrase, the bacterial enzyme catalyzing duplication, transcription and repair of DNA. In vitro activity covers a broad range of gram-positive and gram-negative aerobes and anaerobes; cross-resistance occurs with other fluoroquinolones but generally not with beta-lactams or aminoglycosides.

Warnings & Precautions

Topical ophthalmic use only: Not for injection; do not inject subconjunctivally or introduce directly into the anterior chamber.
Hypersensitivity reactions: Rare anaphylactic reaction, shock and fatal hypersensitivity have been reported in patients receiving systemic quinolones, including ofloxacin, some following the first dose, with cardiovascular collapse, angioedema, airway obstruction, dyspnea, urticaria and itching; discontinue if an allergic reaction occurs and treat serious reactions as an emergency.
Stevens-Johnson syndrome: One report of Stevens-Johnson syndrome progressing to toxic epidermal necrolysis during topical ophthalmic use; discontinue at the first appearance of skin rash or any other sign of hypersensitivity.
Resistant organism overgrowth: Prolonged use may allow overgrowth of nonsusceptible organisms including fungi; if superinfection occurs, discontinue and start alternative therapy, examining with slit lamp and fluorescein where appropriate.

Common Side Effects

Ocular, most frequent: Transient ocular burning or discomfort.
Ocular, other reported: Stinging, redness, itching, chemical conjunctivitis or keratitis, ocular, periocular or facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, eye pain.
Systemic, rare: Dizziness, nausea.

Pregnancy & Lactation

Pregnancy: No adequate and well-controlled studies in pregnant women; use only if the potential benefit justifies the potential risk to the fetus. Not teratogenic in rats or rabbits; embryocidal effects appeared at 9000 times (rat, decreased fetal body weight) and 1800 times (rabbit, increased fetal mortality) the maximum recommended daily ophthalmic dose, and rat dosing up to 360 mg/kg/day in late gestation did not affect late fetal development, labor, delivery, lactation, neonatal viability or growth of the newborn.

Lactation: A single 200 mg oral dose in nursing women produced milk concentrations similar to plasma; excretion in human milk after topical ophthalmic dosing is unknown, so weigh discontinuing nursing against the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness not established below 1 year of age.