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DELIVERY SYSTEM Formulated with Introducing the FIRST and ONLY NSAID indicated to prevent ocular pain in cataract surgery patients 1 Defend against pain and combat postoperative in ammation with the penetrating power of BromSite™ formulated with DuraSite ®1 • DuraSite increases retention time on the ocular surface and absorption of bromfenac 2-5 – Allows for increased aqueous humor concentrations • Ensures complete coverage throughout the day with BID dosing 1 Visit bromsite.com to nd out more. A DROP OF PREVENTION FOR YOUR CATARACT SURGERY PATIENTS Sun Ophthalmics is a division of Sun Pharmaceutical Industries, Inc. © 2016 Sun Pharmaceutical Industries, Inc. All rights reserved. DuraSite ® and BromSite™ are trademarks of Sun Pharma Global FZE. SUN-OPH-BRO-141 09/2016 Indications and Usage BromSite™ (bromfenac ophthalmic solution) 0.075% is a nonsteroidal anti-in ammatory drug (NSAID) indicated for the treatment of postoperative in ammation and prevention of ocular pain in patients undergoing cataract surgery. Important Safety Information • Slow or Delayed Healing: All topical nonsteroidal anti- in ammatory drugs (NSAIDs), including BromSite (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. • Potential for Cross-Sensitivity: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. • Increased Bleeding Time of Ocular Tissue: With some NSAIDs, including BromSite (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 BromSite be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. • Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular References: 1. BromSite [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2016. 2. Hosseini K, Hutcheson J, Bowman L. Aqueous humor concentration of bromfenac 0.09% (Bromday™) compared with bromfenac in DuraSite ® 0.075% (BromSite™) in cataract patients undergoing phacoemulsi cation after 3 days dosing. Poster presented at: ARVO Annual Meeting; May 5-9, 2013; Seattle, Washington. 3. Bowman LM, Si E, Pang J, et al. Development of a topical polymeric mucoadhesive ocular delivery system for azithromycin. J Ocul Pharmacol Ther. 2009;25(2):133-139. 4. ClinicalTrials.gov. Aqueous humor concentration of InSite Vision (ISV) 303 (bromfenac in DuraSite) to Bromday once daily (QD) prior to cataract surgery. https://clinicaltrials.gov/ct2/show/results/ NCT01387464?sect=X70156&term=insite+vision&rank=1. Accessed July 18, 2016. 5. Si EC, Bowman LM, Hosseini K. Pharmacokinetic comparisons of bromfenac in DuraSite and Xibrom. J Ocul Pharmacol Ther. 2011;27(1):61-66. 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. Post-marketing 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. • BromSite should not be administered while wearing contact lenses. The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses. • The most commonly reported adverse reactions in 1% to 8% of patients were anterior chamber in ammation, headache, vitreous oaters, iritis, eye pain, and ocular hypertension. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see brief summary of full Prescribing Information on the adjacent page. NSAID=nonsteroidal anti-in ammatory drug.

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