药品信息:
Information on TWYNSTA
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.
Dosage：
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.
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详细处方信息以本药内容附件PDF文件（201011422393911.pdf）的“原文Priscribing Information”为准
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部分中文 TWYNSTA 处方信息（仅供参考）
【活性成分】 替米沙坦，氨氯地平
【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）
【适应症】高血压，作为单一疗法或与其他抗高血压药物共用。作为初期治疗的患者可能需要多种药物，以达到降压目地。
【药理作用】替米沙坦可以阻止血管收缩和醛固酮分泌血管紧张素II，血管紧张素II是肾素血管紧张素系统的主要升压剂。氨氯地平抑制成血管平滑肌钙离子内流，其次，也能抑制心肌钙离子内流。通过抑制，氨氯地平引起外周阻力减少，血压下降。
【用法用量】成人：每天一次。初始治疗：40/5mg或80/5mg;在2周后滴定最大可用80/10mg。附加疗法：可用于单药治疗，如果服用氨氯地平10毫克出现明显不良反应，改用40/5mg。替代疗法：可替换为滴定组件。肾和/或肝功能损害患者，滴定速度应较慢。75岁以上，肝功能不全的患者不适宜作为初次使用。儿童：不建议使用。
【注意事项】治疗开始之前或密切监测血压变化。充血性心力衰竭，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，妊娠期的患者慎用，同时需要在医师指导下才可使用。哺乳期女性，不建议使用。
【药物间相互作用 】不宜与雷米普利同时使用。高钾血症时与K+同用加强药效，与钾利尿剂加强药效。与地高辛，锂同时服用加强药效。
【不良反应】可能出现周围水肿，头晕，体位性低血压，背部疼痛等不良反应。
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详细处方信息以本药内容附件PDF文件（201011422393911.pdf）的“原文Priscribing Information”为准
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更新于2011年3月8日 |
