BROMSITE

2 DOSAGE AND ADMINISTRATION Instill one drop of BromSite to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days postsurgery. 1 Recommended Dosing One drop of BromSite should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery.

2 Use with Other Topical Ophthalmic Medications BromSite should be administered at least 5 minutes after instillation of other topical medications. BromSite may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

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. 1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.

gov/medwatch. 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.

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. 075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

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 BromSite be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 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. 075%, and should be closely monitored for corneal health.

, 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 Contact Lens Wear BromSite should not be administered while wearing contact lenses.

The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses.

4 CONTRAINDICATIONS None None (4)