Avaclyr ophthalmic ointment 3％.3.5g（acyclovir 阿昔洛韦眼用软膏） - 角膜炎药物

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Avaclyr ophthalmic ointment 3％.3.5g（acyclovir 阿昔洛韦眼用软膏）

药店国别：

产地国家：

美国

处方药：

是

所属类别：

3.5克/管

包装规格：

3.5克/管

计价单位：

管

生产厂家中文参考译名:

Fera Pharmaceuticals

生产厂家英文名:

Fera Pharmaceuticals

该药品相关信息网址1:

https://www.drugs.com/history/avaclyr.html

该药品相关信息网址2:

该药品相关信息网址3:

原产地英文商品名:

Avaclyr ophthalmic ointment 3％ 3.5g/tube

原产地英文药品名:

acyclovir

中文参考商品译名:

Avaclyr眼用软膏 3% 3.5克/管

中文参考药品译名:

阿昔洛韦

曾用名:

简介：

近日，美国食品和药物管理局(FDA)批准眼科外用药Avaclyr（acyclovir ophthalmic ointment）3%,用于治疗疱疹性角膜炎。
单纯疱疹病毒，或HSV，角膜炎是角膜的感染-覆盖由HSV引起的眼睛的有色部分的透明圆顶。感染通常在不损伤眼睛的情况下愈合，但更严重的感染可导致角膜瘢痕或失明。HSV角膜炎是全世界失明的主要原因。
Avaclyr（acyclovir ophthalmic ointment）3％，是单纯疱疹病毒核苷类似物DNA聚合酶抑制剂，用于治疗单纯疱疹病毒（HSV-1和HSV-2）病毒的急性疱疹病毒性角膜炎（树突状溃疡）。患者最常见的不良反应（2-10％）为眼痛（刺痛），点状角膜炎和滤泡性结膜炎。
批准日期：2019年4月1日公司：Fera Pharmaceuticals
AVACLYR（阿昔洛韦[acyclovir]）眼用软膏3％,用于局部眼科用途
最初的美国批准：1982年
作用机制
阿昔洛韦是一种抗病毒药物[见微生物学]。
适应症和用法
AVACLYR（acyclovir ophthalmic ointment）3％，一种herpessimplex病毒核苷类似物DNA聚合酶抑制剂，用于治疗急性疱疹性角膜炎
单纯疱疹病毒（HSV-1和HSV-2）病毒患者（树突状溃疡）。
剂量和给药
每天5次在affectedeye的下穹窿中涂抹1厘米的缎带，直至愈合，然后每天3次，持续7天。
剂量形式和强度
AVACLYR是一种含有3％阿昔洛韦的局部无菌软膏。
禁忌症
AVACLYR禁用于对阿昔洛韦或伐昔洛韦具有已知高敏感性的患者。
不良反应
报告住院患者最常见的不良反应（2-10％）是眼痛（刺痛），点状角膜炎和滤泡性结膜炎。
包装提供/存储和处理
AVACLYR采用3.5克锡管，黑色低密度聚乙烯帽，透明，无色，无菌眼科
局部使用含有3％阿昔洛韦活性药物的软膏。每个管都包装在一个单独的纸箱中。
3.5克管（NDC 48102-026-35）
储存在20°C至25°C（68°F至77°F）。
Fera Pharmaceuticals Announces FDA Approval of Avaclyr(acyclovir ophthalmic ointment)
US Food and Drug Administration (FDA) has approved Fera’s New Drug Application (NDA) for Avaclyr™ (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis. Orphan drug exclusivity was also granted, providing seven years of marketing exclusivity for the product.
“Avaclyr approval is a major milestone for the company,” noted Frank DellaFera, Fera’s founder and President. “Working closely with the eye care community we were able to identify a need for additional options to treat herpetic keratitis. Acyclovir is the gold standard treatment in herpes virus infections so it made sense to provide this therapy in an ophthalmic dosage form1. Fera is thankful to FDA for approving Avaclyr, making it available to physicians and patients in the US.”
Fera launch plans include finalizing its selection of a commercialization partner to provide physicians and patients access to this important therapy.
About Acute Herpetic Keratitis
According to the Center for Disease Control and Prevention (CDC), HSV (Herpes Simplex Virus) keratitis is an infection of the cornea—the clear dome that covers the colored part of the eye—that is caused by HSV. The infection usually heals without damaging the eye, but more severe infections can lead to scarring of the cornea or blindness. HSV keratitis is a major cause of blindness worldwide2-3.
About Avaclyr
Avaclyr (acyclovir ophthalmic ointment) 3%, is a herpes simplex virus nucleoside analog DNA polymerase inhibitor, is indicated in the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus. The most common adverse reactions (2-10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis.