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Twynsta(替米沙坦/氨氯地平)

2009-12-08 21:17:14  作者:新特药房  来源:中国新特药网  浏览次数:752  文字大小:【】【】【
简介: Manufacturer: Boehringer Ingelheim Pharmaceuticals Pharmacological Class: Antihypertensive (angiotensin II receptor blocker + calcium channel blocker) Active Ingredient(s): Telmisa ...

Manufacturer:

Boehringer Ingelheim Pharmaceuticals

Pharmacological Class:

Antihypertensive (angiotensin II receptor blocker + calcium channel blocker)

Active Ingredient(s):

Telmisartan 40mg, amlodipine 5mg; tabs.

Also:

TWYNSTA 40mg/10mg
Telmisartan 40mg, amlodipine 10mg; tabs.

TWYNSTA 80mg/5mg
Telmisartan 80mg, amlodipine 5mg; tabs.

TWYNSTA 80mg/10mg
Telmisartan 80mg, amlodipine 10mg; tabs.

Indication(s):

Hypertension, as monotherapy or with other antihypertensives. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Pharmacology:

Telmisartan blocks the vasoconstriction and aldosterone-secreting effects of angiotensin II, the main pressor agent of the renin-angiotensin system. Amlodipine inhibits the influx of calcium ions into vascular smooth muscle and, to a lesser extent, cardiac muscle. By inhibiting this process, amlodipine causes a reduction in peripheral resistance and a reduction in blood pressure.

Clinical Trials:

An 8-week randomized, double-blind, placebo controlled study in 1461 patients with mild to severe hypertension compared Twynsta to either monotherapy component across 16 treatment arms. The four key treatment combinations, including telmisartan 40mg or 80mg and amlodipine 5mg or 10mg, had statistically significant reductions in in-clinic seated trough cuff systolic and diastolic blood pressure (SBP and DBP) compared to the respective individual monotherapies.

In an active-controlled study, 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5mg were randomized to either Twynsta (40/5 or 80/5) or amlodipine (5mg or 10mg). In a second active-controlled study, 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10mg were randomized to Twynsta (40/10 or 80/10) or amlodipine 10mg. Each of the combination treatments was statistically significantly superior to the respective amlodipine monotherapy doses in the reduction of DBP and SBP after 8-weeks of treatment in both studies.

Legal Classification:

Rx

Adults:

Take once daily. Initial therapy: 40/5mg or 80/5mg; may titrate at 2-week intervals to max 80/10mg. Add-on therapy: may be used if not controlled on monotherapy; if dose-limiting adverse reactions with amlodipine 10mg, switch to 40/5mg tab. Replacement therapy: may be substituted for the titrated components. Renal and/or hepatic impairment: titrate slower. ≥75 years, or hepatic impairment: not for initial use (initially use amlodipine alone, or add amlodipine 2.5mg to telmisartan).

Children:

Not recommended.

Precaution(s):

Correct hypovolemia before starting therapy or monitor closely. CHF. Biliary obstruction. Hepatic or severe renal dysfunction. Renal artery stenosis. Severe obstructive coronary disease. Pregnancy (Cat.D in 2nd and 3rd trimester; Cat.C in 1st trimester); discontinue ASAP when pregnancy detected. Nursing mothers: not recommended.

Interaction(s):

Concomitant ramipril: not recommended. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt supplements. May potentiate digoxin, lithium.

Adverse Reaction(s):

Peripheral edema, dizziness, orthostatic hypotension, back pain.

How Supplied:

Tabs—30, 90

Last Updated:

12/3/2009

勃林格殷格翰制药公司

药理分类:
抗高血压药物(血管紧张素Ⅱ受体阻滞剂+钙通道阻滞剂)

活性成分(补):
替米沙坦40毫克,氨氯地平5毫克;标签。

此外:
TWYNSTA 40mg/10mg
替米沙坦40毫克,氨氯地平10毫克;标签。

TWYNSTA 80mg/5mg
替米沙坦80毫克,氨氯地平5毫克;标签。

TWYNSTA 80mg/10mg
替米沙坦80毫克,氨氯地平10毫克;标签

指示(补):
高血压,作为单一疗法或与其他抗高血压药物。作为初期治疗的患者可能需要多种药物,以达到目标血压。

药理:
替米沙坦阻止血管收缩和醛固酮分泌血管紧张素II,主要升压剂的肾素血管紧张素系统。氨氯地平抑制成血管平滑肌钙离子内流,并在较小的程度上,心脏肌肉。通过抑制这个过程中,氨氯地平引起的外周阻力减少,血压下降。

临床试验:
8周的随机,双盲,安慰剂控制的研究,1461例轻,重度高血压相比Twynsta要么在16个单药治疗部分武器。四个关键的治疗组合,包括替米沙坦40毫克或80毫克和氨氯地平5毫克或10毫克,已在-诊所坐在槽显著减少袖口收缩压和舒张压(收缩压和舒张压)相比,分别个别单一疗法。

在主动控制的研究,1097轻度至重度高血压谁没有得到充分的氨氯地平5毫克控制的患者被随机分在Twynsta(40 / 5或80 / 5)或氨氯地平(5毫克或10毫克)。在第二个主动控制的研究,947例轻,重度高血压谁没有得到充分控制在10毫克氨氯地平患者随机Twynsta(40/10或80/10)或氨氯地平10毫克。对合并的处理每一个有统计学显着优于氨氯地平在各自的舒张压和收缩压后8个星期的治疗,在这两项研究减少单药剂量。


法律分类:
接收

成人:
以每天一次。初始治疗:40/5mg或80/5mg;可滴定在2周间隔最大80/10mg。附加疗法:可用于单药治疗,如果不控制,如果剂量限制与氨氯地平10毫克不良反应,切换到40/5mg标签。替代疗法:可替换为滴定组件。肾和/或肝功能损害:滴定速度较慢。 ≥75岁,肝功能不全或没有为初次使用:(最初单独使用氨氯地平,氨氯地平每公升2.5毫克或添加到替米沙坦)。

儿童:
不建议。

 

预防措施(补):
纠正低血容量治疗开始之前或密切监测。瑞士法郎。胆道梗阻。严重肝或肾功能不全。肾动脉狭窄。严重阻塞性冠状动脉疾病。妊娠(Cat.D在第二和第三孕期,Cat.C在第一三个月);停止在最短的时间怀孕检测。哺乳母亲:不推荐。

互动(补):
伴随雷米普利:不推荐。高钾血症与K +补充,钾利尿剂,钾补充剂含有盐。 5月使可能地高辛,锂。

不良反应(补):
周围水肿,头晕,体位性低血压,背部疼痛。


如何提供:
标签- 30,90


最后更新:
2009年12月3日

 

责任编辑:admin


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