WARNINGS AND PRECAUTIONS
Topical Ophthalmic Use Only
ZYMAXID™ solution should not be introduced directly into the anterior chamber of the eye.
Growth of Resistant Organisms with Prolonged Use
As with other anti-infectives, prolonged use of ZYMAXID™ (gatifloxacin ophthalmic solution) 0.5% may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluoroscein staining.
Avoidance of Contact Lens Wear
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis or during the course of therapy with ZYMAXID™ (see PATIENT COUNSELING INFORMATION, 17.2).
USE IN SPECIFIC POPULATIONS
Pregnancy Category C
Teratogenic Effects: There were no teratogenic effects observed in rats or rabbits following oral gatifloxacin doses up to 50 mg/kg/day (approximately 1000-fold higher than the maximum recommended ophthalmic dose). However, skeletal/craniofacial malformations or delayed ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended ophthalmic dose). In a perinatal/postnatal study, increased late post-implantation loss and neonatal/perinatal mortalities were observed at 200 mg/kg/day (approximately 4000-fold higher than the maximum recommended ophthalmic dose).
Because there are no adequate and well-controlled studies in pregnant women, ZYMAXID™ solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Gatifloxacin is excreted in the breast milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ZYMAXID™ is administered to a nursing woman.
The safety and effectiveness of ZYMAXID™ in infants below one year of age have not been established. ZYMAXID™ has been demonstrated in clinical trials to be safe and effective for the treatment of bacterial conjunctivitis in pediatric patients one year or older (see CLINICAL STUDIES, 14).
No overall differences in safety or effectiveness have been observed between elderly and younger patients.