MOXIFLOXACIN

5 WARNINGS AND PRECAUTIONS Corneal Endothelial Damage and Toxic Anterior Segment Syndrome : Intracameral injections will cause harm to endothelium. ( 5.1 ) Hypersensitivity Reactions : 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. If superinfection occurs, discontinue use and institute alternative therapy. ( 5.3 ) Avoid Contact Lens Wear : Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.4 ) 5.1 Corneal Endothelial Damage and Toxic Anterior Segment Syndrome NOT FOR INTRACAMERAL USE OR INJECTION. Moxifloxacin ophthalmic solution will cause damage to the corneal endothelium if introduced directly into the anterior chamber of the eye. Toxic Anterior Segment Syndrome (TASS) has been reported following intraocular administration of moxifloxacin. TASS is typically characterized by anterior chamber inflammatory reactions, such as fibrin, cell or flare and corneal edema, but other events, such as hypopyon, keratic precipitates or vitreous opacities may also occur. 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 The most common adverse reactions reported in 1% to 2% of patients were eye irritation, pyrexia, and conjunctivitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 moxifloxacin ophthalmic 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% to 2% of patients.