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  药店国别: 加拿大药房
产地国家: 加拿大
所属类别: 心血管系统药物->治疗心功能不全药物
处方药:处方药
包装规格: 75毫克/片 28片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
赛诺菲安万特
生产厂家英文名:
SANOFI AVENTIS US
该药品相关信息网址1:
http://products.sanofi-aventis.us/PLAVIX/PLAVIX.html
该药品相关信息网址2:
http://products.sanofi-aventis.us/PLAVIX/PLAVIX.html
原产地英文商品名:
PLAVIX 75mg/tab 28tabs/box (Min order qty: 2)
原产地英文药品名:
CLOPIDOGREL BISULFATE
中文参考商品译名:
波立维 75毫克/片 28片/盒 (最低订货量:2)
中文参考药品译名:
硫酸氢氯吡格雷
原产地国家批准上市年份:
1997/11/17
英文适应病症1:
atherosclerosis
英文适应病症2:
heart attack
英文适应病症3:
stroke
临床试验期:
完成
中文适应病症参考翻译1:
动脉硬化
中文适应病症参考翻译2:
心脏病发作
中文适应病症参考翻译3:
中风
药品信息:

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详细处方信息以本药内容附件PDF文件(201011823353135.pdf)的“原文     Priscribing Information”为准
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部分波立维中文处方信息,仅供参考

PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2S•H2SO4 and its molecular weight is 419.9.
Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°.
PLAVIX for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base.

Each tablet contains hydrogenated castor oil, hydroxypropylcellulose, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin. The tablets are polished with Carnauba wax.

CLINICAL PHARMACOLOGY
Mechanism of Action and Pharmacodynamic Properties
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. A variety of drugs that inhibit platelet function have been shown to decrease morbid events in people with established cardiovascular atherosclerotic disease as evidenced by stroke or transient ischemic attacks, myocardial infarction, unstable angina or the need for vascular bypass or angioplasty. This indicates that platelets participate in the initiation and/or evolution of these events and that inhibiting platelet function can reduce the event rate.

Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. This action is irreversible. Consequently, platelets exposed to clopidogrel's active metabolite are affected for the remainder of their lifespan (about 7 to 10 days). Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.

Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other drugs, not all patients will have adequate platelet inhibition.

Dose dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses of PLAVIX. Repeated doses of 75 mg PLAVIX per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7. At steady state, the average inhibition level observed with a dose of 75 mg PLAVIX per day was between 40% and 60%. Platelet aggregation and bleeding time gradually return to baseline values after treatment is discontinued, generally in about 5 days.

Pharmacokinetics
Absorption
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/mL after a single 75-mg oral dose) occurred approximately 45 minutes after dosing. Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.

Effect of Food
The effect of food on the bioavailability of the parent compound or active metabolite is currently not known.

Distribution
Clopidogrel and the main circulating inactive metabolite bind reversibly in vitro to human plasma proteins (98% and 94%, respectively). The binding is nonsaturable in vitro up to a concentration of 100 mcg/mL.

[药品商品名称]: 波立维
[药品正式名称]: 硫酸氢氯吡格雷 Clopidogrel hydrogen sulfate
[药品英文名称]: Plavix
[基本药理]:  血小板聚集抑制剂,通过选择性抑制二磷酸腺苷(ADP)与血小板结合及继发由ADP介导的糖蛋白复合物活化。
[临床用途]:  适用于有过近期发作的中风、心肌梗塞和确诊外周动脉硬化的患者,波立维(氯吡格雷)可减少动脉粥样硬化性事件的发生(如心肌梗塞,中风和血管性死亡)。
[给药途径及用量]: 推荐剂量每日75mg,对老年患者和肾病患者不需调整剂量
[用法用量]: 推荐剂量为每天75mg,与或不与食物同服。对于老年患者和肾病患者不需调整剂量。
[不良反应]: 出血,波立维(氯吡格雷)严重出血事件的发生率分别为1.4% 胃肠道:如腹痛,消化不良,胃炎和便秘 皮疹和其它皮肤病 中枢和周围神经系统:头痛、眩晕、头昏和感觉异常 肝脏和胆道疾病 禁 忌 证对药品或本品任一成分过敏 严重的肝脏损伤 活动性病理性出血,如消化性溃疡或颅内出血 注意事项:氯吡格雷延长出血时间,对于有伤口(特别是在胃肠道和眼内)易出血的病人应慎用。病人应知服用波立维止血时间可能比往常长,同时病人应向医生报告异常出血情况,手术前和服用其它新药前病人应告知医生他们在服用波立维。 由于患有肾脏损伤病人使用氯吡格雷的经验极有限,因此这些病人应慎用波立维(氯吡格雷)。 严重肝病的病人可能有出血倾向,这类病人使用本药的经验极有限,应慎用波立维。 由于服用华法令也有出血倾向,所以服用时不推荐同时使用华法令。 对于同时服用易出现胃肠道伤口的药物(如非甾体消炎药)的病人应慎用波立维 未见服用本药后对驾驶或心理学检测产生影响 不建议孕妇及哺乳期妇女服用此药。在儿科使用的安全性和有效性还未明确。

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详细处方信息以本药内容附件PDF文件(201011823353135.pdf)的“原文     Priscribing Information”为准
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更新日期: 2015-01-07
附件:








201011823353135.pdf    

 
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