1 INDICATIONS AND USAGE ZYMAXID® (gatifloxacin ophthalmic solution) 0.5% solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic Gram-Positive Bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group* Streptococcus oralis * Streptococcus pneumoniae Aerobic Gram-Negative Bacteria: Haemophilus influenzae *Efficacy for this organism was studied in fewer than 10 infections. ZYMAXID® ophthalmic solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group* , Streptococcus oralis * , Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections. (1)
3 DOSAGE FORMS AND STRENGTHS Five (5) mL bottle containing 2.5 mL of a 0.5% sterile topical ophthalmic solution. 5 mL size bottle filled with 2.5 mL of gatifloxacin ophthalmic solution, 0.5%. (3)
4 CONTRAINDICATIONS None None
5 WARNINGS AND PRECAUTIONS Topical Ophthalmic Use Only (5.1) Growth of Resistant Organisms with Prolonged Use (5.2) Avoidance of Contact Lenses. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with ZYMAXID® (5.3) 5.1 Topical Ophthalmic Use Only ZYMAXID® solution should not be introduced directly into the anterior chamber of the eye. 5.2 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, fluorescein staining. 5.3 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).
6 ADVERSE REACTIONS Most common adverse reactions occurring in ≥ 1% of patients included worsening of conjunctivitis, eye irritation, dysgeusia, and eye pain. (6) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical studies with ZYMAXID® , the most frequently reported adverse reactions occurring in ≥ 1% of patients in the gatifloxacin study population (N=717) were: worsening of the conjunctivitis, eye irritation, dysgeusia, and eye pain. Additional adverse events reported with other formulations of gatifloxacin ophthalmic solution include chemosis, conjunctival hemorrhage, dry eye, eye discharge, eyelid edema, headache, increased lacrimation, keratitis, papillary conjunctivitis, and reduced visual acuity.
7 DRUG INTERACTIONS Specific drug interaction studies have not been conducted with ZYMAXID® ophthalmic solution.
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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. 8.3 Nursing Mothers 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. 8.4 Pediatric Use 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). 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.