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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗微生物药物->抗病毒药物
处方药:处方药
包装规格: 75毫克/毫升 375毫克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
GILEAD SCIENCES INC
生产厂家英文名:
GILEAD SCIENCES INC
该药品相关信息网址1:
http://www.drugs.com/mtm/vistide.html
该药品相关信息网址2:
http://www.rxlist.com/vistide-drug.htm
原产地英文商品名:
VISTIDE 75mg/ml 375mg/vial
原产地英文药品名:
CIDOFOVIR
中文参考商品译名:
VISTIDE 75毫克/毫升 375毫克/瓶
中文参考药品译名:
西多福韦
原产地国家批准上市年份:
1996/06/26
英文适应病症1:
Cytomegalovirus retinitis
临床试验期:
完成
中文适应病症参考翻译1:
巨细胞病毒性视网膜炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(201051000300737.pdf)的“原文Priscribing Information”为准
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部分中文Vistide处方资料(仅供参考)

【名 称】
    化学名:西多福韦
  英文名:cidofovir
  商品名:Vistide (西多福韦注射液)
  规格: 375mg/5ml
  适应症:AIDS病人的CMV视网膜炎(巨细胞病毒性视网膜炎)
【背景】
  巨细胞病毒(CMV)是危害性最大的疱疹病毒之一,人体的感染率高达50%~80%,一般呈隐性感染。在人体免疫功能低下时,如感染HIV,癌症患者接受放、化疗,器官或骨髓移植用免疫抑制剂抗排异等均会激发为活动性感染,可引发急性视网膜炎、间质性肺炎、胃肠炎和脑炎等,未经治疗者致盲或致死率均在70%以上。随着HIV感染率的上升及器官移植的广泛开展,对于抗CMV药物的需求也日益增加。
【临床疗效】
  西多福韦对CMV有高度的抑制活性,对某些耐更昔洛韦或膦甲酸的病毒株也有活性。并对单纯疱疹病毒(HSV)、带状疱疹病毒(VZV)、人类乳头瘤病毒(HPV)等也有很强的活性。与其它抗CMV药物相比,西多福韦的疗效显著且持久,开始使用头两周每周给药一次,此后每两周只需给药一次,使用方便。
  据AntiviraL Research 75(2007)1-13,西多福韦将来注重治疗痘病毒感染及人乳头瘤病毒感染。
  优点:
  w 抑制DNA多聚酶的作用、阻断DNA的合成,而不依赖病毒激酶;
  w 抗病毒谱广,包括单纯疱疹病毒、带状疱疹病毒、巨细胞病毒及其他病毒(例如EB病毒、带状疱疹病毒6、腺病毒、乙型肝炎病毒),还包括胸甙激酶耐药株和某些膦甲酸耐药株;
  w 用药方便,每周用药1次,持续2周,然后每2周用药1次;无需中心静脉插管(每隔2周,外周静脉插管给药1次)。
  缺点:很差的生物利用度,因此只能静注。还有较严重的不可逆肾毒性。
  w 大多数患者都有发生(53%);
  w 很小的剂量即可发生急性肾功能衰竭;
  w 结果导致近曲肾小管细胞损伤和代谢性酸中毒,早期表现为蛋白尿和糖尿;
  w 肾功能障碍者(肌酐大于1.5mg/dl)为本品使用禁忌证。
【项目简介】
  西多福韦(cidofovir, HPMPC)是新型的胞嘧啶核苷膦酰基甲醚衍生物,由美国Gilead 公司开发。
  西多福韦注射液(商品名:Vistide)1996 年首先在美国上市,随后在英、法、意等多国上市。Gilead公司负责Vistide在美国市场的销售,海外市场由合作伙伴Pharmacia Corporation公司(现Pfizer公司)负责。
  西多福韦的外用凝胶剂型由Gilead公司开发。在完成I、II期临床后,2004年其上市申请(AIDS病人的难治性HSV感染)被FDA拒绝,原因是临床数据不充分(具体原因不祥)。Gilead已中止了cidofovir外用凝胶制剂的开发(Direct communication, Gilead, 29 Jun 2004)。未见到该公司及其他公司后续开发的报道。
  此外,还有个别使用西多福韦滴眼液进行动物模型上抗病毒研究的报道。

Vistide
Generic Name: cidofovir (si DOF o veer)
Brand Names: Vistide

What is Vistide (cidofovir)?
Cidofovir is an antiviral medication that works by preventing certain viral cells from multiplying in your body.

Cidofovir is used to treat an eye infection called cytomegalovirus retinitis (CMV) in people who are infected with HIV (human immunodeficiency virus).

Cidofovir may also be used for purposes other than those listed in this medication guide.

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What is the most important information I should know about Vistide (cidofovir)?
Do not receive this medication if you are allergic to cidofovir, probenecid (Benemid), or sulfa drugs, or if you have severe kidney disease. Cidofovir may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Use an effective form of birth control while you are using cidofovir and for at least 1 month after your treatment ends.

Cidofovir can affect fertility (ability to have children) in men. If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using cidofovir.

Cidofovir must be used together with an oral (taken by mouth) medicine called probenecid (Benemid). Be sure to read the medication guide or patient instructions provided with each of your medications.

There are many other medicines that can interact with cidofovir. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
Cidofovir has caused certain types of tumors in animals. It is not known if humans would also have an increased risk of tumors. Talk with your doctor about your specific risk.

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What should I discuss with my health care provider before receiving Vistide (cidofovir)?
Do not receive this medication if you are allergic to cidofovir, probenecid (Benemid), or sulfa drugs, or if you have severe kidney disease.
Do not receive cidofovir if you have used any of the following medications within the past 7 days:
pentamidine (Nebupent, Pentam);
tacrolimus (Prograf);
amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), 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).

Before using cidofovir, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may not be able to receive cidofovir, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Use an effective form of birth control while you are using cidofovir and for at least 1 month after your treatment ends.
This medication can affect fertility (ability to have children) in men. If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using cidofovir.

It is not known whether cidofovir passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Cidofovir has caused certain types of tumors in animals. It is not known if humans would also have an increased risk of tumors. Talk with your doctor about your specific risk.

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How is cidofovir used?
Cidofovir is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion. You may also be given an IV saline solution for 1 to 3 hours before and after you receive your cidofovir injection. This IV treatment can take up to 6 hours to complete.

To keep you from getting dehydrated, you may also be given an IV saline solution for 1 to 3 hours before and after you receive your cidofovir injection. Your IV treatment can take up to 6 hours to complete.

Cidofovir must be used together with an oral (taken by mouth) medicine called probenecid (Benemid). Be sure to read the medication guide or patient instructions provided with each of your medications.

Cidofovir and probenecid are usually given once a week for 2 weeks, and then once every 2 weeks. It is important to receive this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.

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What happens if I miss a dose?
Call your doctor if you miss an appointment to receive your cidofovir injection.

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What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine.
Symptoms of a cidofovir overdose are not known.

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What should I avoid while receiving Vistide (cidofovir)?
There are no restrictions on food, beverages, or activity while using cidofovir unless your doctor has told you otherwise.

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Vistide (cidofovir) 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. Call your doctor at once if you have any of these serious side effects:
urinating less than usual or not at all;
fever, chills, body aches, flu symptoms;
any change in your vision; or
increased thirst and urination, loss of appetite, weakness, constipation.
Less serious side effects are more likely to occur, such as:
nausea, vomiting, diarrhea, loss of appetite;
white patches or sores inside your mouth or on your lips;
headache;
mild skin rash;
hair loss; or
cough.

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. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Vistide (cidofovir)?
Before using cidofovir, tell your doctor if you are using any of the following drugs:
acetaminophen (Tylenol);
acyclovir (Zovirax);
zidovudine (Retrovir, AZT);
bumetanide (Bumex);
clofibrate (Atromid);
famotidine (Pepcid);
furosemide (Lasix);
methotrexate (Rheumatrex, Trexall);
theophylline (Elixophyllin, Respbid, Theobid, Theo-Dur, and others);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others;
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
diazepam (Valium) or similar medicines such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), estazolam (ProSom), flurazepam (Dalmane), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), triazolam (Halcion), and others.

If you are using any of these drugs, you may not be able to receive cidofovir, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect cidofovir. 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.

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Where can I get more information?
Your pharmacist has information about cidofovir written for health professionals that you may read.

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.

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 详细处方信息以本药内容附件PDF文件(201051000300737.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-07-10
附件:






201051000300737.pdf    

 
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