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英文药名: Valcyte(Valganciclovir Tablets)
中文药名: 缬更昔洛韦片
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
包装规格：
·450mg *60 片
·450mg*28 片
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。
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What is Generic Valcyte (Valganciclovir Hcl)?
Valganciclovir is an antiviral drug. It works by preventing viral cells from multiplying in your body. Valganciclovir will not cure CMV but it can help control the infection.Valganciclovir treats cytomegalovirus (CMV) infection of the eye in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir also prevents CMV infection in patients who have received an organ transplant (kidney, heart, or kidney-pancreas).Valganciclovir may also be used for purposes other than those listed in this medication guide.Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte). Be aware that the strength of these two medications is different. A valganciclovir tablet contains more medicine than a ganciclovir capsule. You may not need to use as many valganciclovir tablets as you did ganciclovir capsules. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed. An overdose of this medication can cause serious illness.
What is the most important information I should know about Generic Valcyte (Valganciclovir Hcl)?
Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together. If your doctor switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte), the number of pills you use each day may change. To avoid overdosage, take only as many valganciclovir tablets as your doctor has prescribed. Using valganciclovir while you are pregnant may cause harm to the unborn baby. If a man fathers a child while using this medication, the baby may have birth defects. Use an effective form of birth control while you are using valganciclovir. If you are a man, use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir. Do not use a tablet that has been accidentally broken. The medicine from a crushed or broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If you must handle a broken tablet, ask your doctor or pharmacist how to handle and dispose of the tablet safely. Valganciclovir can lower the blood cells in your body that control bleeding and help you fight infection. Your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor. Contact your doctor right away if you have any bleeding or signs of infection (fever, chills, body aches, or flu symptoms).
What should I discuss with my healthcare provider before taking Generic Valcyte (Valganciclovir Hcl)?
Before taking this medication, tell your doctor if you have:kidney disease,liver disease, ora blood cell disorder (such as anemia).Tell your doctor if you are on hemodialysis or if you have recently had a radiation treatment.Valganciclovir is in the FDA pregnancy category C. This means that it is not known if it will be harmful to an unborn baby. A similar drug called ganciclovir (Cytovene) did cause birth defects in animal studies. Using valganciclovir while you are pregnant could also cause harm to the unborn baby. Do not use this medication without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. If a man fathers a child while using valganciclovir, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir. This medication can affect fertility (your ability to have children), whether you are a man or a woman.You should not breast-feed while you are using valganciclovir. It is not known if this medication passes into breast milk. If you have HIV or AIDS, you should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk. Valganciclovir may cause cancer. Talk to your doctor about your individual risk.
How should I take Generic Valcyte (Valganciclovir Hcl)?
Valganciclovir should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take the medication for longer than your doctor has prescribed.Take each dose with a full glass of water. Take valganciclovir with food. Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. It is very important to take this medicine at the same time each day. To best treat your condition, you should not miss any doses.Do not crush or break a valganciclovir tablet. Do not use a tablet that has been accidentally broken. The medicine from a broken tablet can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken tablet, ask your doctor or pharmacist how to dispose of the tablet safely. You should have your eyes checked at least every 4 to 6 weeks while you are using valganciclovir. Your doctor may want you to have eye exams more often.Valganciclovir can lower the blood cells in your body that help you fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Store valganciclovir at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a valganciclovir overdose may include seizure (convulsions), kidney failure (urinating more or less than usual, blood in the urine, swelling or numbness in your hands or feet, pain in your lower back or sides), or signs of liver damage (yellowing of the skin or eyes, severe and sudden stomach pain, diarrhea, vomiting).
What should I avoid while taking Generic Valcyte (Valganciclovir Hcl)?
If you have AIDS, follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles.Use birth control to prevent pregnancy while you are using valganciclovir, whether you are a man or a woman. Valganciclovir use by either parent can cause birth defects. If you are a man, use a condom to keep from causing a pregnancy while you are taking valganciclovir. Continue using condoms for at least 90 days after you stop taking valganciclovir. Valganciclovir can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Side effects of Generic Valcyte (Valganciclovir Hcl)
Stop taking valganciclovir and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);easy bruising, unusual bleeding;numbness or tingling in a part of the body;signs of infection (fever, chills, body aches, flu symptoms); orseizure (convulsions).Other, less serious side effects may be more likely to occur. Continue to take valganciclovir and talk to your doctor if you experience:mild nausea, vomiting, diarrhea, stomach pain;headache;sleepiness or dizziness;weakness, lack of coordination;confusion;tremor (uncontrolled shaking); orsleep problems (insomnia).Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Generic Valcyte (Valganciclovir Hcl)?
Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together. Before taking valganciclovir, talk to your doctor if you are using any of the following drugs:zidovudine (Retrovir, AZT);didanosine (Videx, ddI);mycophenolate (CellCept);drugs that weaken your immune system (such as cancer medicine or steroids); orprobenecid (Benemid, Probalan).If you are using any of these drugs, you may not be able to take valganciclovir, or you may require a dosage adjustment or special monitoring.There may be other drugs not listed that can affect valganciclovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Generic Name Valganciclovir Hcl
Search Name Valcyte Generic 450mg Tab
Supply Name VALGAN
Brand Generic GENERIC
Presentation Foil
Dosage Tab
USA Brand Valcyte
Manufacture Cipla Limited
Strength 450mg
Search Terms Valcyte ,VALGAN ,Valganciclovir Hcl | 
