bromfenac 0.075%

5 WARNINGS AND PRECAUTIONS Slow or Delayed Healing (5.1) Potential for Cross-Sensitivity (5.2) Increased Bleeding Time of Ocular Tissue (5.3) Keratitis and Corneal Effects (5.4) Contact Lens Wear (5.5) 5.1 Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac ophthalmic solution 0.075%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.2 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac ophthalmic solution 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.3 Increased Bleeding Time of Ocular Tissue With some NSAIDs, including bromfenac ophthalmic solution 0.075%, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 5.4 Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac ophthalmic solution 0.075%, and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events. 5.5 Contact Lens Wear Bromfenac ophthalmic solution should not be administered while wearing contact lenses. The preservative in bromfenac ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses.

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Slow or Delayed Healing [ see Warnings and Precautions (5.1) ] • Potential for Cross-Sensitivity [ see Warnings and Precautions (5.2) ] • Increased Bleeding Time of Ocular Tissue [ see Warnings and Precautions (5.3) ] • Keratitis and Corneal Reactions [ see Warnings and Precautions (5.4) ] • Contact Lens Wear [ see Warnings and Precautions (5.5) ] The most commonly reported adverse reactions in 1-8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 (toll free), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most commonly reported adverse reactions in 1 to 8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.