近日，美国FDA批准BromSite（bromfenac 溴芬酸钠）眼用溶液0.075%，用于白内障手术后的炎症和预防术后的眼部疼痛。BromSite是FDA批准的首个用于白内障手术后预防疼痛和治疗炎症的非甾体抗炎药物(NSAID)。 批准日期：2016年4月11日 公司：Sun Pharmaceutical Industries，Inc BROMSITE（溴芬酸[bromfenac]）眼用溶液 0.075％，用于局部眼科给药 美国最初批准：1997年 作用机制 Bromfenac是一种具有抗炎作用的非甾体类抗炎药（NSAID）活动。其行动机制被认为是由于它的原因通过抑制环加氧酶1和2来阻断前列腺素合成的能力。 前列腺素已经在许多动物模型中被证明是它们的调节剂某些种类的眼内炎症。 在动物眼中进行的研究中，前列腺素已被证明可以破坏血液中的水分幽门屏障，血管舒张，血管通透性增加，白细胞增多，和增加的眼压。 适应症和用法 BromSite是一种非甾体类抗炎药（NSAID）治疗术后炎症和预防患者的眼痛接受白内障手术。 剂量和给药 每天两次向受影响的眼睛滴入一滴BromSite（早晨起伏）从手术前1天开始，手术当天开始，术后14天开始。 剂量形式和强度 局部眼用溶液：溴芬酸0.075％。 禁忌症 没有 警告和注意事项 •缓慢或延迟愈合 •交叉敏感性的潜力 •增加眼部组织的出血时间 •角膜炎和角膜效应 •隐形眼镜磨损 不良反应 1-8％的患者中最常报告的不良反应是：前部室内炎症，头痛，玻璃体漂浮物，虹膜炎，眼痛和眼部炎症高血压。 包装提供/存储和处理 BromSite（溴芬酸眼用溶液）0.075％以白色不透明的形式提供低密度聚乙烯（LDPE）塑料瓶和半透明滴管提示，灰色高密度聚乙烯（HDPE）吸管帽。一个白色提供防篡改的顶盖。 每个瓶子都用密封的箔片提供层压袋。 在7.5mL瓶中加入5mL（NDC No. 49708-754-41） 存储 储存在15ºC - 25ºC（59ºF - 77ºF）。 治疗完成后丢弃。 完整说明书附件：https://www.bromsite.com/pdf/BromSitePI.pdf BROMSITE(bromfenac ophthalmic solution)0.075% BromSite (bromfenac ophthalmic solution) 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite™ is administered as 1 drop in the affected eye twice daily, starting one day prior to surgery, the day of surgery, and continuing 14 days postsurgery. BromSite™ provides 24-hour coverage with BID dosing. Important Safety Information (continued) Increased Bleeding Time of Ocular Tissue: With some NSAIDs, including BromSite™, 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. Keratitis and Corneal Effects: 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 cornealperforation. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including BromSite™, and should be closely monitored for corneal health. 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. 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.