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维德思囊片VALTREX(VALACYCLOVIR HCL)

2011-04-03 18:44:28  作者:新特药房  来源:中国新特药网天津分站  浏览次数:2761  文字大小:【】【】【
简介: 通用名: 盐酸伐昔洛韦片 英文名: VALACICLOVIR HYDROCHLORIDE TABLETS 药品类别 :抗病毒类 【性状】本品为薄膜衣片,除去薄膜衣后显白色或类白色。 【药理毒理】本品是阿昔洛韦的前体药物,口服后吸 ...

 通用名: 盐酸伐昔洛韦片
英文名: VALACICLOVIR HYDROCHLORIDE TABLETS
药品类别 :抗病毒类
【性状】本品为薄膜衣片,除去薄膜衣后显白色或类白色。
【药理毒理】本品是阿昔洛韦的前体药物,口服后吸收迅速并在体内很快转化为阿昔洛韦,其抗病毒作用为阿昔洛韦所发挥,阿昔洛韦进入疱疹感染细胞之后,与脱氧核苷竞争病毒胸腺嘧啶激酶或细胞激酶,药物被磷酸化成活化型无环鸟苷三磷酸酯,作为病毒复制的底物与脱氧鸟嘌呤三磷酸酯竞争病毒DNA多聚酶,从而抑制了病毒DNA合成,显示抗病毒作用。本品体内的抗病毒活性优于阿昔洛韦,对单纯性疱疹病毒I型和II型的治疗指数分别比阿昔洛韦高42.91%和30.13%。对水痘带状疱疹病毒也有很高的疗效,对哺乳动物宿主细胞的毒性很低。大鼠和小鼠灌胃给药的LD50分别4.4g/kg和1.51g/kg。由于本品在体内很快转化为阿昔洛韦,其代谢物在体内没有蓄积现象。在不同阶段的长期毒性试验中,本品与阿昔洛韦具有相同的安全性。
药代动力学 本品口服后迅速吸收转化为阿昔洛韦,血中阿昔洛韦达峰时间为0.88~1.75小时。口服生物利用度为67±13%,是阿昔洛韦的3~5倍。本品进入体内后广泛分布,可分布至多种组织中,其中胃、小肠、肾、肝、淋巴结和皮肤组织中浓度最高,脑组织中的浓度最低。本品在体内全部转化为阿昔洛韦,代谢物主要从尿中排除,其中阿昔洛韦占46%~ 59%,8-羟基-9-鸟嘌呤占25%~30%,9-羟基甲氧基鸟嘌呤占11%~12%。阿昔洛韦原形为单相消除,血消除半衰期(t1/2β)为2.86±0.39小时。
【适应症】用于治疗水痘带状疱疹及I型、II型单纯疱疹病毒感染,包括初发和复发的生殖器疱疹病毒感染。本品可用于阿昔洛韦的所有适应症。
【用法用量】口服一次0.3g,一日2次,饭前空腹服用。带状疱疹连续服药10日。单纯性疱疹连续服药7日。
【不良反应】偶有头晕、头痛、关节痛、恶心、呕吐、腹泻、胃部不适、食欲减退、口渴、白细胞下降、蛋白尿及尿素氮轻度升高、皮肤瘙痒等,长程给药偶见痤疮、失眠、月经紊乱。
禁忌症 :对本品及阿昔洛韦过敏者禁用。
【注意事项】
1.对更昔洛韦过敏者也可能对本品过敏。
2.脱水或已有肝、肾功能不全者慎用。肾功能不全者在接受本品治疗时,需根据肌酐清除率来校正剂量。
3.严重免疫功能缺陷者长期或多次应用本品治疗后可能引起单纯疱疹病毒和带状疱疹病毒对本品耐药。如单纯疱疹患者应用本品后皮损不见改善者应测试单纯疱疹病毒对本品的敏感性。
4.随访检查:由于生殖器疱疹患者大多易患子宫颈癌,因此患者至少应一年检查一次,以早期发现。
5.一旦疱疹症状与体征出现,应尽早给药。
6.服药期间应给予患者充分的水,防止阿昔洛韦在肾小管内沉淀。
7.一次血液透析可使阿昔洛韦的血药浓度减低60%,因此血液透析后应补给一次剂量。
8.生殖器复发性疱疹感染以间歇短程疗法给药有效。由于动物实验曾发现本品对生育的影响及致突变作用,因此口服剂量与疗程不应超过推荐标准。生殖器复发性疱疹的长程疗法也不应超过6个月。
9.本品对单纯疱疹病毒的潜伏感染和复发无明显效果,不能根除病毒。
【孕妇及哺乳期妇女用药】阿昔洛韦能通过胎盘,孕妇用药需权衡利弊。阿昔洛韦在乳汁中的浓度为血药浓度的0.6~4.1倍,哺乳期妇女应慎用。
【儿童用药】儿童用药的安全性和有效性尚未确定。
【老年患者用药】由于生理性肾功能的衰退,本品剂量与用药间期需调整。
【药物相互作用】
1.与齐多夫定(Zidovudine)合用可引起肾毒性,表现为深度昏睡和疲劳。
2.与丙磺舒竞争性抑制有机酸分泌,合用丙磺舒可使阿昔洛韦的排泄减慢,半衰期延长,体内药物蓄积。   
【贮藏: 密封,在干燥处保存。


【原产地英文商品名】VALTREX 500mg/Caplet 84Tablets
【原产地英文药品名】VALACYCLOVIR HCL
【中文参考药品译名】盐酸伐昔洛韦
【中文参考商品译名】
·维德思 500毫克/囊片 42片/盒
·维德思 500毫克/囊片 84片/盒
·维德思 1克/囊片 4片/盒
·维德思 1克/囊片 30片/盒
·维德思 500毫克/小胶囊,100片/盒
·维德思 1克/囊片 42片/盒
【生产厂家中文参考译名】葛兰素史克
【生产厂家英文名】GlaxoSmithKline

Valacyclovir Hydrochloride Tablets

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to:
Valtrex (GlaxoSmithKline LLC)

Indication:
Teva Pharmaceuticals announced the availability of Valacyclovir Hydrochloride Tablets. This product is AB-rated and bioequivalent to Valtrex Caplets. Valacyclovir Hydrochloride Tablets are a nucleoside analogue DNA polymerase inhibitor indicated for cold sores (herpes labialis), genital herpes, and herpes zoster in adult patients, as well as cold sores (herpes labialis) in pediatric patients. The tablets are available in 500- and 1000-mg strengths, in bottle sizes of 30 and 90.

Dosage:
Tablets: 500 and 1000 mg
--------------------------------------------------------------------------------------------

Valtrex
Generic Name: valacyclovir (val a SYE kloe veer)
Brand Names: Valtrex

What is Valtrex?
Valtrex is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valtrex will not cure herpes, but it can lessen the symptoms of the infection.

Valtrex is used to treat infections caused by herpes viruses in adults and children. Illnesses caused by herpes viruses include genital herpes, cold sores, shingles, and chickenpox.

Valtrex is used to treat cold sores in children who are at least 12 years old, and to treat chickenpox in children who are at least 2 years old.

Valtrex may also be used for other purposes not listed in this medication guide.

------------------------------------------------

Important information about Valtrex
Before taking Valtrex, tell your doctor if you have HIV/AIDS, a weak immune system, kidney disease (or if you are on dialysis), or if you have had a kidney or bone marrow transplant.
Valtrex can be harmful to the kidneys, and these effects are increased when it is used together with other medicines that can harm the kidneys. Tell your doctor about all other medications you are using. You may need dose adjustments or special tests when taking certain medications together with Valtrex.

Treatment with Valtrex should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Herpes virus can be passed from an infected mother to her baby during childbirth. If you have genital herpes, it is very important to prevent herpes lesions during your pregnancy so that you do not have a genital lesion when your baby is born.
Valtrex will not prevent the spread of genital herpes. Herpes infections are contagious and you can infect other people even while you are taking with Valtrex.

Stop taking Valtrex and call your doctor right away if you have any signs of a serious side effect that can harm red blood cells, such as: fever, easy bruising or bleeding, red spots on the skin (not related to herpes or chickenpox), bloody diarrhea, vomiting, pale or yellowed skin, weakness, fainting, or urinating less than usual or not at all.

Do not give Valtrex to a child unless it has been prescribed by a doctor.

------------------------------------------------

Before taking Valtrex
Do not take this medicine if you are allergic to valacyclovir or acyclovir (Zovirax).
If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking Valtrex, tell your doctor if you have:
HIV/AIDS, or other conditions that can weaken the immune system;
kidney disease (or if you are on dialysis); or
if you have had a kidney or bone marrow transplant.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. However, herpes virus can be passed from an infected mother to her baby during childbirth. If you have genital herpes, it is very important to prevent herpes lesions during your pregnancy so that you do not have a genital lesion when your baby is born. Valtrex passes into breast milk and may harm a nursing infant. Do not take this medication without telling your doctor if you are breast-feeding a baby. Do not give Valtrex to a child unless it has been prescribed by a doctor. Older adults may be more likely to have harmful side effects while taking Valtrex. Talk to your doctor about your specific risk.

------------------------------------------------

How should I take Valtrex?
Take Valtrex exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Treatment with Valtrex should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters). This medication might not be as effective if you first start taking it 1 or 2 days after the start of your symptoms.

Take each dose with a full glass of water. Drink plenty of water while you are taking Valtrex to keep your kidneys working properly. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Valtrex can be taken with or without food.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Valtrex will not treat a viral infection such as the common cold or flu.
Lesions caused by herpes viruses should be kept as clean and dry as possible. Wearing loose clothing may help to prevent irritation of the lesions.

Store Valtrex tablets at room temperature away from moisture and heat. Store Valtrex liquid in a refrigerator. Do not freeze. Throw away any unused Valtrex that is older than 28 days.
See also: Valtrex dosage in more detail

------------------------------------------------

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. 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.
Overdose symptoms may include urinating less than usual or not at all.

------------------------------------------------

What should I avoid while taking Valtrex?
Valtrex will not prevent the spread of genital herpes. Herpes infections are contagious and you can infect other people even while you are taking with Valtrex.

Avoid sexual intercourse or use a latex condom to prevent spreading the virus to others. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

------------------------------------------------

Valtrex side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking Valtrex and call your doctor right away if you have any of the following signs of a serious side effect that can harm red blood cells:
fever, easy bruising or bleeding;
red spots on the skin (not related to herpes or chickenpox);
bloody diarrhea, vomiting;
pale or yellowed skin;
weakness or fainting; or
urinating less than usual or not at all.

Call your doctor at once if you have any of these other serious side effects:
pain in your lower back;
drowsiness, mood changes, increased thirst, loss of appetite, nausea and vomiting;
swelling, weight gain, feeling short of breath;
confusion, agitation, aggression, hallucinations, trouble concentrating;
feeling shaky or unsteady;
problems with speech or vision; or
seizure (convulsions).

Less serious Valtrex side effects may include:
nausea, stomach pain;
headache, dizziness, tired feeling, depression;
joint pain;
menstrual pain;
mild skin rash; or
stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

------------------------------------------------

What other drugs will affect Valtrex?
Valtrex can be harmful to the kidneys, and these effects are increased when it is used together with other medicines that can harm the kidneys. Before taking Valtrex, tell your doctor if you are also using:
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexal);
pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;
medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or
cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with Valtrex. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

------------------------------------------------

Where can I get more information?
Your pharmacist can provide more information about Valtrex.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

责任编辑:admin


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