近日，美国食品和药物管理局（FDA）批准OMIDRIA（phenylephrine and ketorolac，苯肾上腺素和酮咯酸）眼内溶液1％/3％上市许可的首款药物，用于白内障手术或人工晶状体置换术（ILR）。
该药可预防术中瞳孔缩小（瞳孔收缩）并减少术后疼痛。
Omidria是瞳孔扩张剂（去氧肾上腺素）和抗炎剂（酮咯酸）的专利组合，其被添加到白内障手术和其他ILR程序（包括屈光性晶状体交换）期间使用的标准冲洗溶液中。 总的来说，这些外科手术是在美国进行的最常见的外科手术（每年近400万）。
批准日期：2014年6月13日  公司：OMEROS CORPORATION
OMIDRIA（去氧肾上腺素和酮咯酸[phenylephrine and ketorolac]）眼内溶液1％/0.3％，用于眼部冲洗液
美国最初批准：2014年
作用机制
Omidria（phenylephrine/ketorolac）中的两种活性药物成分（API）通过预防术中瞳孔缩小和减少术后疼痛来维持瞳孔化。
去氧肾上腺素是α1-肾上腺素能受体激动剂，并且在眼睛中通过收缩虹膜的桡肌来充当散瞳剂。酮咯酸是一种非甾体类抗炎药，可抑制环氧合酶（COX-1和COX-2），导致前列腺素组织浓度降低，从而减轻疼痛
由于手术创伤。 酮咯酸通过抑制继发于眼外科损伤或虹膜的直接机械刺激的前列腺素合成，也防止手术诱导的瞳孔缩小。
适应症和用法
OMIDRIA是α1-肾上腺素能受体激动剂和非选择性环氧合酶抑制剂，适用于：
•通过预防术中瞳孔缩小来维持瞳孔大小
•减少术后疼痛
OMIDRIA被添加到白内障手术或人工晶状体置换术中使用的眼部冲洗液中。
剂量和给药
•每个小瓶的OMIDRIA必须在用于给予接受白内障手术或眼内晶状体移位的单个患者给药前进行稀释。
•在500 mL眼部冲洗液中稀释4mL OMIDRIA。
根据外科手术的需要使用灌溉溶液。
剂量形式和强度
含有去氧肾上腺素10.16mg/mL（1％）和酮咯酸2.88 mg/mL（0.3％）的眼内溶液用于单个患者。
禁忌症
对本产品的任何组分过敏
警告和注意事项
全身暴露于去氧肾上腺素可能导致血压升高。
不良反应
最常见的不良反应（≥2％）是眼睛刺激，后囊混浊，眼压升高和前房炎症。
包装提供/存储和处理
Omidria（去氧肾上腺素和酮咯酸眼内溶液）1％/0.3％在含有4mL无菌溶液的透明5mL玻璃单剂患者用品中提供，用于添加到眼部冲洗溶液中。
Omidria以多包装提供，包含：
4个样品瓶：NDC 62225-600-04或
10个小瓶：NDC 62225-600-10
储存：储存在20˚到25˚C（68˚到77˚F）。 避光。
OMIDRIA(phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution
Initial U.S. Approval: 2014
CLINICAL PHARMACOLOGY
Initial U.S. Approval:  2014
Mechanism of Action: The two active pharmaceutical ingredients (API) in Omidria, phenylephrine and ketorolac, act to maintain pupil size by preventing intraoperative miosis, and reducing postoperative pain.
Phenylephrine is an a 1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.
INDICATIONS AND USAGE: 
OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for:
Maintaining pupil size by preventing intraoperative miosis.
Reducing postoperative pain.
OMIDRIA is added to an irrigation solution used during cataract surgery or intraocular lens replacement.
DOSAGE AND ADMINISTRATION
Omidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.
The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions.
Do not use if the solution is cloudy or if it contains particulate matter.
HOW SUPPLIED
Drug UPDATES:  OMIDRIA ® (phenylephrine and ketorolac injection) 1% / 0.3%
[Drug information/PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
REFERENCE(S)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21470688-4e81-4ea5-ac38-f72e10552e7e