FDA label eeacc337-dcff-cec2-22f4-bad41b97bd39

5 WARNINGS AND PRECAUTIONS Hypersensitivity ( 5.1 ) Growth of Resistant Organisms with Prolonged Use ( 5.2 ) Corneal Endothelial Cell Injury ( 5.3 ) 5.1 Hypersensitivity Patients receiving topical gatifloxacin have experienced hypersensitivity reactions including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, even following a single dose. There have been rare reports of Stevens-Johnson Syndrome reported in association with topical ophthalmic gatifloxacin use. If an allergic reaction to gatifloxacin occurs, discontinue the drug and contact your physician [see Patient Counseling Information ( 17 )]. 5.2 Growth of Resistant Organisms with Prolonged Use Prolonged use of gatifloxacin ophthalmic solution may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates examine the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. 5.3 Corneal Endothelial Cell Injury Gatifloxacin ophthalmic solution is for topical ophthalmic use. Gatifloxacin ophthalmic solution may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Growth of Resistant Organisms With Prolonged Use [see Warnings and Precautions ( 5.2 )] Corneal Endothelial Cell Injury [see Warnings and Precautions ( 5.3 )] Most common adverse reactions occurring in 5% to 10 % of patients included conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp., at 1-800-706-5575 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 gatifloxacin ophthalmic solution, the most frequently reported adverse reactions in the overall study population were: conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. These reactions occurred in approximately 5% to 10% of patients. Other reported reactions occurring in 1% to 4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance. An additional adverse reaction reported with gatifloxacin ophthalmic solution in other clinical studies includes worsening of the conjunctivitis. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of gatifloxacin ophthalmic solution 0.3%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: anaphylactic reactions and angioedema (including pharyngeal, oral or facial edema), blepharitis, dyspnea, eye pruritus, eye swelling (including corneal and conjunctival edema), hypersensitivity, nausea, pruritus (including pruritus generalized), rash, urticaria, vision blurred.