英文药名: Acuvail(Ketorolac Eye Drops)
中文药名: 酮咯酸氨丁三醇滴眼液
生产厂家: Allergan
药品简介
Allergan公司近日表示美国FDA已批准Acuvail(酮咯酸氨丁三醇滴眼液, 0.45%) 用于治疗白内障手术后的疼痛与感染。Acuvail为一种先进的无防腐剂的滴眼剂,PH值为6.8,去离子滴眼剂。Acuvail中含有羧甲基纤维素,可使该药粘在眼球表面与提高患者的舒适感。
公司表示,Acuvail无防腐剂、耐受性良好、每天两次使用方便,这些特点将使该药为白内障手术患者提供一种有价值的新疗法。公司预计Acuvail可于2009年9月在美国正式上市。
规格:0.45% 30支 x 0.4ml
ACUVAIL®(酮咯酸氨丁三醇滴眼液)0.45%
最初美国批准:1991 适应症
眼科ACUVAIL®解决方案是治疗白内障手术后的疼痛和炎症的非甾体类消炎表示。 剂量和用法
一滴ACUVAIL®应适用于病人患眼每日两次白内障手术前1天开始,并继续通过术后第2周。 剂型和优势
4.5毫克/毫升酮咯酸氨丁三醇单用小瓶的解决方案。 注意事项:
延迟愈合 潜力跨灵敏度 增加出血时,由于干扰血小板聚集 包括角膜炎角膜的影响 不良反应
发生在1-6%的患者最常见的不良反应,眼压增高,眼结膜出血,视力模糊。
日期:10/2009
ACUVAIL® (ketorolac tromethamine ophthalmic solution) 0.45% ACUVAIL® is a nonsteroidal, anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery approved by the U.S. Food and Drug Administration in 2009. Important Safety Information Contraindications ACUVAIL® solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. Warnings and Precautions Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) 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. Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. 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 corneal perforation. These events may be sight threatening. 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. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
ACUVAIL® should not be administered while wearing contact lenses. Adverse Reactions The most common adverse events were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these events may be the consequence of the cataract surgical procedure. |