Ocuflox (Ofloxacin 0.3%)

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.