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缬更昔洛韦片|Valcyte(Valganciclovir Tablets)

2012-07-23 17:34:20 作者：新特药房来源：中国新特药网天津分站浏览次数：276 文字大小：【大】【中】【小】

简介： 英文药名: Valcyte(Valganciclovir Tablets) 中文药名: 缬更昔洛韦片品牌药生产厂家: Hoffman-La-Roche 药品名称药品名：盐酸缬更昔洛韦片英文名：Valganciclovir Hydrochloride Tablets 剂型 ...

关键字：缬更昔洛韦片|Valcyte(Valganciclovir Tablets)

英文药名: Valcyte(Valganciclovir Tablets)

中文药名: 缬更昔洛韦片

品牌药生产厂家: Hoffman-La-Roche

药品名称

药品名：盐酸缬更昔洛韦片
英文名：Valganciclovir Hydrochloride Tablets
剂型：片剂
性状: 本品为粉红色卵圆形薄膜包衣口服片。
药理毒性

缬更昔洛韦是更昔洛韦的左旋缬氨酰酯(前体药物)，口服后被小肠和肝内的酯酶迅速转化成更昔洛韦。更昔洛韦是一个合成的2’-脱氧鸟苷的类似物，它在体外和体内都可以抑制疱疹病毒的复制。敏感的人类病毒包括人类巨细胞病毒（HCMV），单纯疱疹病毒-1和单纯疱疹病毒-2（HSV-1，HSV-2），人疱疹病毒-6，7，8（HHV-6，7，8），EB病毒，水痘-带状疱疹病毒（VZV）和乙型肝炎病毒。在被巨细胞病毒（CMV）感染的细胞中，更昔洛韦首先被病毒的蛋白激酶UL97磷酸化成单磷酸更昔洛韦。再被细胞内的蛋白激酶进一步磷酸化成三磷酸更昔洛韦，然后在细胞内被缓慢代谢。移除细胞外的更昔洛韦后，在HSV或HCMV感染的细胞中的更昔洛韦的半衰期分别是18小时和6~24小时。由于磷酸化很大程度地依赖病毒的蛋白激酶，所以更昔洛韦的磷酸化优先发生在被病毒感染的细胞。
更昔洛韦抑制病毒的活性主要通过抑制病毒DNA的合成：
（a）竞争性抑制病毒DNA聚合酶，使脱氧三磷酸鸟苷不能结合到DNA上，
（b）三磷酸更昔洛韦结合到病毒DNA上使DNA链的延长终止或受限制。在体外更昔洛韦对CMV抗病毒作用的IC50范围为0.14μM（0.04ug/ml）到14μM（3.5ug/ml）。
药代动力学

临床上缬更昔洛韦片的抗病毒作用表现在病人应用缬更昔洛韦片治疗四周后CMV病毒的排出率从46%（32/69）降低到7%（4/55）。

适应症

盐酸缬更昔洛韦片适用于治疗获得性免疫缺陷综合征（AIDS）合并巨细胞病毒（CMV）视网膜炎。

用法用量

注意--避免药物过量的基本要求是严格按推荐剂量给药。
标准剂量缬更昔洛韦片口服给药，与食物同服。缬更昔洛韦片被迅速大量的转化成更昔洛韦。以更昔洛韦测定的缬更昔洛韦片的绝对生物利用度比更昔洛韦胶囊高10倍，因此应严格遵守如下的缬更昔洛韦片片剂剂量和用法说明。
任何疑问，请遵医嘱！

不良反应

临床研究结果有关缬更昔洛韦片的结果缬更昔洛韦片是更昔洛韦的前体药物，口服后迅速转化成更昔洛韦。因此已知的与更昔洛韦有关的不良反应预计也会在应用缬更昔洛韦片时发生。所有在缬更昔洛韦片临床研究中观察到的不良事件以前在应用更昔洛韦时也都观察到过。在每组79例病人参加的随机应用缬更昔洛韦片或静脉内更昔洛韦治疗28天（21天诱导治疗，7天维持治疗）的临床试验中，两组的安全性数据有可比性。报告最多的不良事件是腹泻、中性粒细胞减少和发热。在口服缬更昔洛韦片治疗组中，腹泻、口腔念珠菌感染、头痛和疲乏报告较多；而在静脉内更昔洛韦治疗组中，恶心和注射部位相关事件报告较多。
注意事项

以更昔洛韦测定的缬更昔洛韦片的绝对生物利用度比更昔洛韦胶囊高10倍。缬更昔洛韦片不能1：1的代替更昔洛韦胶囊。以前应用更昔洛韦胶囊要改用缬更昔洛韦片片剂的病人，应被告知：如果服用超过处方剂量的缬更昔洛韦片片，有药物过量的危险。在治疗过程中建议监测全血细胞计数和血小板计数。有严重白细胞减少，中性粒细胞减少，贫血和/或血小板减少的病人，建议采用血细胞生长因子治疗和/或考虑暂停服药对肾功能不全的病人，需要按照肌酐清除率调整剂量对进行血液透析的病人（CrCl<10ml/min），建议使用静脉内更昔洛韦(而不是缬更昔洛韦片)，并按照已批准的更昔洛韦处方信息上的剂量下调公式计算剂量(参见特殊剂量指南和特殊人群的药代动力学)应用缬更昔洛韦片和/或更昔洛韦后有报道出现惊厥、镇静、头晕、共济失调，和/或精神错乱。如果这些情况发生，可能会影响需要精力集中的活动，包括病人驾驶汽车和操作机器的能力在合用亚胺培南-西司他丁（泰能）和更昔洛韦的病人中有发生惊厥的报道。缬更昔洛韦片不应该与泰能合用，除非可能获得的益处高于潜在的危险性。齐多夫定（Zidovudine）和缬更昔洛韦片单独应用都有可能引起中性粒细胞减少和贫血。有些病人可能不能耐受全量合用这两种药在与缬更昔洛韦片合用时，地丹诺辛（Didanosine）的血浆浓度可能会升高；因此应密切监测病人的地丹诺辛毒性合用缬更昔洛韦片和其他已知有骨髓抑制或与肾功能不全有关的药物时，会导致毒性增加.

规格包装
450mg *60 片
450mg *28 片

Valcyte (Valganciclovir HCl)

Valcyte (valganciclovir HCl) is an antiviral medicine that can treat the CMV (cytomegalovirus) infections of the eye. The CMV can be transmitted to a baby before even being born. The infection is usually harmless and rarely causes any diseases. For most healthy individuals that get this virus on birth, there are a few symptoms and no long term medical consequences. Once in the organism, the virus remains active, but generally latent throughout the patient’s life. There are two different forms of infection – primary and recurrent. The primary infection can cause more problems in pregnancy than the recurrent one. Anyway, if the immune system is weakened, the virus can easily turn active and cause various complications. Most infected adults and children don’t present any symptoms. Those who do, might present fever, gland inflammations, tiredness and fatigue. These symptoms usually show up 1 to 3 months after the infection is encountered.

Valcyte (valganciclovir HCl) initially hit the market in 2001. It was immediately accepted by the FDA. The latest concentration formula is up since 2009 though. Although the CMV infection is not quite harmful, this medicine requires a medical prescription. As some of the CMV symptoms can easily be taken for a cold or a flu, the specialist doctor must first identify the exact cause of your condition. This medicine is only prescribed in the AIDS patients, with a low immune system. It might be too powerful for other people.

Administration
Valcyte (valganciclovir HCl) is available in two forms – tablets and oral suspension. The tablets are prescribed both for adults and children. They need to be swallowed whole, without being crushed or chewed. You can take them with a glass of water. Take both the tablets and the oral suspension with food. The food will help your organism assimilate the drug faster. The children who encounter problems while trying to swallow the tablets whole may get the oral suspension form of this medicine. The oral suspension is not quite advised in adults, since the dosage will be different at higher doses.

The oral suspension form of Valcyte (valganciclovir HCl) comes with a special device used to measure the dose. Although it might look like a spoon, don’t use other similar tools, but only this medical recipient.

Warnings
Keep the distance when it comes to people suffering from contagious infections. Valcyte (valganciclovir HCl) lowers your immune system. Valcyte (valganciclovir HCl) will not prevent the HIV from being transmitted. Don’t share your personal hygiene objects and don’t have unprotected sexual intercourse.