Zymaxid (Gatifloxacin 0.5%)

Common Side Effects

Ocular, at least 1%: Worsening of conjunctivitis, eye irritation, eye pain (N = 717 treated in the clinical studies).
Nonocular, at least 1%: Dysgeusia.
Other formulations, not this product: Chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, increased lacrimation, keratitis, red eye, papillary conjunctivitis, reduced visual acuity, headache, all reported in studies of other gatifloxacin ophthalmic solutions rather than this one.
Postmarketing, frequency not estimable: Anaphylaxis, angioedema (pharyngeal, oral or facial), dyspnea, blepharitis, eye pruritus, eye swelling including corneal and conjunctival edema, allergic dermatitis, blurred vision, nausea, pruritus, rash, urticaria.

Pregnancy & Lactation

Pregnancy: No available data in pregnant women to inform drug-associated risk. Oral dosing in rats and rabbits through organogenesis produced no adverse developmental outcomes at clinically relevant doses; teratogenic effects in rat fetuses (skeletal and craniofacial malformations, delayed ossification, atrial enlargement, reduced fetal weight) appeared at 150 mg/kg/day and above, roughly 600-fold the maximum recommended human ophthalmic dose on a mg/m2 basis, with no teratogenic effects in either species up to 50 mg/kg/day. A perinatal and postnatal rat study showed increased late gestation fetal loss and neonatal mortality only at 200 mg/kg/day, roughly 800-fold the ophthalmic dose.

Lactation: No information on presence in human milk, effects on the breastfed infant, or effects on milk production. Found in rat milk after oral dosing, though systemic levels after topical ocular use are low.

Pediatric Use