ZIRGAN 0.15%(更昔洛韦眼用凝胶)
制造商：
西连治疗
药理分类：
核苷类似物
活性成分（补）：
更昔洛韦0.15％;眼凝胶;含有苯扎氯。
指示（补）：
急性疱疹性角膜炎（树突状溃疡）。
药理作用：
更昔洛韦抑制单纯疱疹病毒（单纯疱疹病毒）DNA的复制。更昔洛韦是由病毒和细胞转化胸苷激酶（TK）的对更昔洛韦三磷酸，其中2种方式抑制病毒DNA的合成：将引物链DNA病毒的病毒DNA聚合酶和直接纳入竞争性抑制，导致在DNA链终止和预防复制。
临床试验：
四个随机，对照，多中心研究，进行评估与单纯疱疹性角膜炎患者的Zirgan疗效。一审，一个开放标签研究涉及164例患者，表明Zirgan是不逊于阿昔洛韦眼药膏3％，与树突状溃疡患者。第7天临床决议方面取得了77比72与Zirgan那些谁收到阿昔洛韦％％的患者。另外三个单屏蔽试验，共涉及213个病人，也表明Zirgan将不逊于阿昔洛韦眼药膏3％。树突状溃疡的临床决议第7天取得了72比69与Zirgan阿昔洛韦％％的患者。
法律分类：
接收
成人和儿童：
<2yrs：不推荐。 ≥2yrs：1下降，受影响的眼（南）5倍每天（每3小时在清醒时），直至角膜溃疡愈合，然后1滴3次7天。
警告/注意事项：
治疗期间，接触镜片取出。妊娠（Cat.C）。哺乳的母亲。
不良反应（补）：
视力模糊，眼睛刺痛，点状角膜炎，结膜充血。
如何提供：
凝胶五克
最后更新：
2010年5月27日
Manufacturer:
Sirion Therapeutics
Pharmacological Class:
Nucleoside analogue
Active Ingredient(s):
Ganciclovir 0.15%; ophthalmic gel; contains benzalkonium chloride.
Indication(s):
Acute herpetic keratitis (dendritic ulcers).
Pharmacology:
Ganciclovir inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which inhibits the synthesis of viral DNA in 2 ways: competitive inhibition of viral DNA polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.
Clinical Trials:
Four randomized, controlled, multicenter studies were conducted to assess the efficacy of Zirgan in patients with herpetic keratitis. The first trial, an open-label study which involved 164 patients, demonstrated that Zirgan was non-inferior to acyclovir ophthalmic ointment 3%, in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 77% of patients treated with Zirgan versus 72% of those who received acyclovir. Three additional single-masked trials, which involved 213 total patients, also demonstrated Zirgan to be non-inferior to acyclovir ophthalmic ointment 3%. Clinical resolution of dendritic ulcers at Day 7 was achieved in 72% of patients treated with Zirgan versus 69% for acyclovir.
Legal Classification:
Rx
Adults & Children:
<2yrs: not recommended. ≥2yrs: 1 drop in the affected eye(s) 5 times daily (every 3 hours while awake) until corneal ulcer heals, then 1 drop 3 times daily for 7 days.
Warnings/Precautions:
Remove contact lenses during therapy. Pregnancy (Cat.C). Nursing mothers.
Adverse Reaction(s):
Blurred vision, eye irritation, punctate keratitis, conjunctival hyperemia.
How Supplied:
Gel—5g
Last Updated:
5/27/2010