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ILEVRO(nepafenac ophthalmic suspension 0.3%)

2017-11-02 08:36:11  作者:新特药房  来源:互联网  浏览次数:1  文字大小:【】【】【
简介: 部份中文奈帕芬胺资料(仅供参考)奈帕芬胺(Nepafenac)是一种新型眼用非甾体类解热镇痛抗炎药(NSAIDs),用于治疗白内障手术引起的眼部疼痛和炎症。与传统 NSAIDs 相比,奈帕芬胺的化学结构 有利于该 ...

部份中文奈帕芬胺资料(仅供参考)
奈帕芬胺(Nepafenac)是一种新型眼用非甾体类解热镇痛抗炎药(NSAIDs),用于治疗白内障手术引起的眼部疼痛和炎症。与传统 NSAIDs 相比,奈帕芬胺的化学结构 有利于该药迅速穿透角膜并分布于其作用靶位,因而有助于降低药物在角膜表面的积聚,减少眼球表面并发症的发生,具有渗透力强、靶向作用强、毒副作用小等优点。
奈帕芬胺经眼部给药后,可迅速穿过角膜,并在眼组织水解酶的作用下转化为氨芬酸(一种NSAID);而氨芬酸又通过抑制前列腺素H合成酶(环氧化酶),阻断前列腺素的合成,来发挥其抗炎止痛的作用。正如人们所知,前列腺素是引起眼内炎症的介质之一,能导致血-房水屏障崩溃、血管扩张、血管通透性增加和白细胞趋化等,此外,前列腺素还能通过非胆碱能机制收缩虹膜括约肌,引发眼科手术过程中及手术后的缩瞳反应。NSAIDs经眼部给药后,可抑制前列腺素在虹膜、睫状体和结膜的合成,因此可预防眼部炎症的发生,减少相关的疼痛。
2005年8月19日美国食品与药品管理局(FDA)批准由Alcon公司研制的奈帕芬 胺眼用混悬液(商品名为 Nevanac,规格 0.1%),用于治疗白内障手术相关性疼痛和炎症,是首个批准上市的眼用NSAID前体药物制剂。EMA还批准了奈帕芬胺(nepafenac, 由爱尔康开发)的新增适应症,可以用于减轻糖尿病患者白内障手术后的疼痛和炎症,以及降低糖尿病患者白内障手术后出现黄斑水肿的风险。2012年10月16日,Alcon公司再一次申报商品名为Ilevro(规格为 0.3%)奈帕芬胺眼用混悬液,并获得FDA批准。
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产地国家: 美国 
原产地英文商品名:
ILEVRO OPH SUSP 0.3% 1.7ML 
原产地英文药品名:
Nepafenac
中文参考商品译名:
ILEVRO眼用悬浮液 0.3% 1.7毫升/瓶
中文参考药品译名:
奈帕芬胺
生产厂家中文参考译名:
ALCON LABORATORIES INC
生产厂家英文名:
ALCON LABORATORIES INC


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产地国家:美国 
原产地英文商品名:
ILEVRO OPH SUSP 0.3% 3ML
原产地英文药品名:
Nepafenac
中文参考商品译名:
ILEVRO眼用悬浮液 0.3% 3毫升/瓶
中文参考药品译名:
奈帕芬胺
生产厂家中文参考译名:
ALCON LABORATORIES IN
生产厂家英文名:
ALCON LABORATORIES IN

ILEVRO® (nepafenac ophthalmic suspension) 0.3%
ILEVRO® EYE DROPS SUSPENSION
Eye Drops Suspension
Nepafenac 0.3%
INDICATIONS AND USAGE
ILEVRO® (nepafenac ophthalmic suspension) 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.
Dosage and Administration
One drop of ILEVRO® Suspension should be applied to the affected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery.
IMPORTANT SAFETY INFORMATION
Contraindications
ILEVRO® Suspension is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs.
Warnings and Precautions
•Increased Bleeding Time – With some nonsteroidal anti-inflammatory drugs including ILEVRO® Suspension there exists the potential for increased bleeding time. Ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.
•Delayed Healing – Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including ILEVRO® Suspension may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
•Corneal Effects – Use of topical NSAIDs may result in keratitis. In some 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. Patients with evidence of corneal epithelial breakdown should immediately discontinue use.
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.
Use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events.
•Contact Lens Wear – ILEVRO® Suspension should not be administered while using contact lenses.
Adverse Reactions
The most frequently reported ocular adverse reactions following cataract surgery occurring in approximately 5 to 10% of patients were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation.
For additional information about ILEVRO® Suspension

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治疗白内障0.1%混悬液Nevanac(nepafenac)获FDA批准上市
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