近日，新型0.45％眼科制剂ACUVAIL(ketorolac tromethamine ophthalmic solution)获FDA批准上市，用于白内障手术后的疼痛和炎症治疗。
批准日期：2017年11月1日 公司：艾尔建公司
ACUVAIL（酮咯酸三甲胺[ketorolac tromethamine]）滴眼液 0.45％
批准日期：公司：
美国初次批准：1991年
作用机理
酮咯酸氨丁三醇是一种非甾体类抗炎药，当全身给药时，已显示出止痛，抗炎和解热活性。据认为其作用机理是由于其抑制前列腺素生物合成的能力。
适应症和用途
ACUVAIL眼药水是一种非甾体类抗炎药，可用于白内障手术后的疼痛和炎症治疗。
剂量和给药
在白内障手术之前的第一天开始，患者应每天两次对患眼施用一滴ACUVAIL，并持续至术后第二周。
剂量形式和强度
一次性小瓶中含有4.5mg/mL酮咯酸三甲胺的ACUVAIL眼药水。
禁忌症
对本产品的任何成分过敏。
警告和注意事项
延迟愈合。
交叉敏感性或超敏感性。
由于干扰血小板聚集，增加了出血时间。
角膜病包括角膜炎
不良反应
在1-6％的患者中最常见的不良反应是眼压升高，结膜出血和视物模糊。
包装供应/存储和处理方式
ACUVAIL（酮咯酸三甲胺眼药水）0.45％可作为无菌溶液，以透明的LDPE一次性小瓶形式提供，包装在3个铝箔袋中，每袋10瓶：
30个一次性样品瓶，每个0.4mL：NDC 0023-3507-31
存放：存放于15o-30ºC（59o-86ºF）。将小瓶存放在小袋中，避光。折叠袋末端封闭。
完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3cea5803-a446-4d2c-9747-f3fb034332c8
ACUVAIL(ketorolac tromethamine ophthalmic solution) 0.45% Important Information
INDICATION
ACUVAIL ophthalmic solution is a nonsteroidal anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery.
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 (eg, 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 postsurgery 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% to 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.