1 INDICATIONS AND USAGE MOXEZA® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans* Corynebacterium macginleyi* Enterococcus faecalis* Micrococcus luteus* Staphylococcus arlettae* Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus saprophyticus* Staphylococcus warneri* Streptococcus mitis* Streptococcus pneumoniae Streptococcus parasanguinis* Escherichia coli* Haemophilus influenzae Klebsiella pneumoniae* Propionibacterium acnes Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections. MOXEZA ® solution is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerococcus viridans*, Corynebacterium macginleyi*, Enterococcus faecalis*, Micrococcus luteus*, Staphylococcus arlettae*, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus*, Staphylococcus warneri*, Streptococcus mitis*, Streptococcus pneumoniae, Streptococcus parasanguinis*, Escherichia coli*, Haemophilus influenzae, Klebsiella pneumoniae*, Propionibacterium acnes, Chlamydia trachomatis* *Efficacy for this organism was studied in fewer than 10 infections.
3 DOSAGE FORMS AND STRENGTHS 4 mL bottle filled with 3 mL of sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base. 4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin hydrochloride, 0.5% as base. (3)
4 CONTRAINDICATIONS None. None. (4)
5 WARNINGS AND PRECAUTIONS Topical ophthalmic use only. (5.1) Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. (5.2) Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. (5.3) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. (5.4) 5.1 Topical Ophthalmic Use Only NOT FOR INJECTION. MOXEZA® solution is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. 5.2 Hypersensitivity Reactions In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. 5.3 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible 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. 5.4 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to MOXEZA® solution in 1263 patients, between 4 months and 92 years of age, with signs and symptoms of bacterial conjunctivitis. The most frequently reported adverse reactions were eye irritation, pyrexia and conjunctivitis, reported in 1-2% of patients. The most common adverse reactions reported in 1-2% of patients were eye irritation, pyrexia, and conjunctivitis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 25,000 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 5,000 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day. Since there are no adequate and well-controlled studies in pregnant women, MOXEZA® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when MOXEZA® solution is administered to a nursing mother. 8.4 Pediatric Use The safety and effectiveness of MOXEZA® solution in infants below 4 months of age have not been established. There is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals. 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.