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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->B-受体阻断剂
处方药:处方药
包装规格: 10毫克/片 30片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
FOREST LABS
生产厂家英文名:
FOREST LABS
该药品相关信息网址1:
http://www.bystolic.com/
该药品相关信息网址2:
http://heart.gzbaozhilin.com/NewDrugs/gxy/200803/12.html
原产地英文商品名:
BYSTOLIC 10mg/tablet 30tablets/box
原产地英文药品名:
NEBIVOLOL HCL
中文参考商品译名:
BYSTOLIC 10毫克/片 30片/盒
中文参考药品译名:
盐酸奈必洛尔
原产地国家批准上市年份:
2007/12/17
英文适应病症1:
hypertension
英文适应病症2:
Heart and blood vessel disease
临床试验期:
完成
中文适应病症参考翻译1:
高血压
中文适应病症参考翻译2:
心血管疾病
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010122801090625.pdf)的“原文Priscribing Information”为准
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CLINICAL PHARMACOLOGY
General
Nebivolol is a  β-adrenergic receptor blocking agent. In extensive metabolizers (most of the population) and at doses less than or equal to 10 mg, nebivolol is preferentially  β1 selective. In poor metabolizers and at higher doses, nebivolol inhibits both  β1 - and  β2 - adrenergic receptors. Nebivolol lacks intrinsic
sympathomimetic and membrane  stabilizing activity at  therapeutically relevant concentrations. At clinically relevant doses, BYSTOLIC does not demonstrate α1-adrenergic receptor blockade activity. Various metabolites, including glucuronides, contribute to β-blocking activity. 
 Pharmacodynamics
The mechanism of action of the antihypertensive response of BYSTOLIC has not been definitively established. Possible factors that may be involved include: (1) decreased heart rate, (2) decreased myocardial contractility, (3) diminution of tonic sympathetic outflow to  the periphery from cerebral vasomotor centers, (4) suppression of renin activity and (5) vasodilation and decreased peripheral
vascular resistance. 
 Pharmacokinetics
Nebivolol is metabolized by a number of routes, including glucuronidation and hydroxylation by CYP2D6. The active isomer (d-nebivolol) has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers (most people), and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers. This has less importance than usual, however, because the metabolites, including the hydroxyl metabolite and glucuronides (the predominant circulating metabolites), contribute to β-blocking activity.  
Plasma levels of d–nebivolol increase in proportion to dose in EMs and PMs for doses up to 20mg. Exposure to l-nebivolol is higher than to d-nebivolol but l-nebivolol contributes little to the drug’s  activity as d-nebivolol’s beta receptor affinity is > 1000-fold higher than l-nebivolol. For the same dose, PMs attain a 5-fold higher Cmax and 10-fold higher AUC of d-nebivolol than do EMs. d-Nebivolol accumulates about 1.5-fold with repeated once-daily dosing in EMs.
 Absorption and Distribution
Absorption of BYSTOLIC is similar to an oral solution. The absolute bioavailability has not been determined.   Mean peak plasma nebivolol concentrations occur approximately 1.5 to 4 hours
post-dosing in EMs and PMs.  Food does not alter the pharmacokinetics  of nebivolol. Under fed conditions, nebivolol glucuronides are slightly reduced. BYSTOLIC may be administered
without regard to meals.  
The  in vitro human plasma protein binding of nebivolol is approximately 98%, mostly to albumin, and is independent of nebivolol concentrations. 

奈比洛尔为β-阻段剂系列高血压治疗药物的新成员。12月17日,FDA宣布批准抗高血压新药奈比洛尔(nebivolol,Bystolic)上市。奈比洛尔为β-阻段剂系列高血压治疗药物的新成员。 在美国,成年人高血压发病率约为1/3。高血压平时没有特别症状,但可导致中风、心衰、心脏病发作、肾衰竭甚至死亡的风险,因此常被称作隐行杀手。奈比洛尔为患者控制血压提供了新选择。

 3项持续3个月以上的随机双盲多中心安慰剂对照的临床研究评价了奈比洛尔的疗效和安全性。 第4项安慰剂对照研究中,服用其它2种降压药物后降压效果不充分的患者,再接受本品治疗,达到了良好的效果。4项临床研究中总共超过2000例患者服用奈比洛尔,其药效与同类β-阻段剂药物的药效相当。 临床研究中,奈比洛尔最常见不良反应为头疼、疲劳、头晕和腹泻。

Bystolic由北卡罗莱纳州的Mylan Bertek制药公司开发,纽约Forest Laboratories公司负责奈比洛尔的销售。

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 详细处方信息以本药内容附件PDF文件(2010122801090625.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-6-27
附件:
2010122801090625.pdf    







 
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