Country: Taívan
Tungumál: kínverska
Heimild: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
TELMISARTAN;;AMLODIPINE BESILATE
台灣百靈佳殷格翰股份有限公司 台北市中山區民生東路三段2號12樓 (12469866)
C09DB04
錠劑
TELMISARTAN (2408005600) MG; AMLODIPINE BESILATE (2412402220) eq. to 10mg free baseMG
鋁箔盒裝
製 劑
須由醫師處方使用
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BINGER STRASSE 173, D-55216 INGELHEIM AM RHEIN, GERMANY DE
telmisartan and amlodipine
治療高血壓,此複方藥品不適用於起始治療。
註銷日期: 2020/01/31; 註銷理由: 自請註銷; 有效日期: 2021/09/14; 英文品名: Twynsta Tablets 80/10 mg
已註銷
2011-09-14
1 INDICATIONS AND USAGE Treatment of hypertension, it is not recommended to use this combination as initial therapy. [Note] TWYNSTA (telmisartan/amlodipine) tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents. Data from an 8-week, placebo- controlled, multidose, factorial trial provide estimates of the probability of reaching a blood pressure goal with TWYNSTA compared to telmisartan or amlodipine monotherapy and placebo _[see_ _section Clinical _ _Studies (14.1)]_. The figures below provide estimates of the likelihood of achiev- ing systolic and diastolic blood pressure control with TWYNSTA 80/10 mg tablets, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was esti- mated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small num- bers of subjects with high baseline blood pressures. The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal at 8 weeks. For exam- ple, a patient with a baseline blood pressure of 160/110 mmHg has about a 16% likelihood of achieving a goal of <140 mmHg (systolic) and 16% likelihood of achieving <90 mmHg (diastolic) on placebo. The likelihood of achieving these same goals on telmisartan is about 46% (systolic) and 26% (diastolic). The likelihood of achieving these same goals on amlodipine is about 69% (systolic) and 22% (diastolic). These likelihoods rise to 79% for systolic and 55% for diastolic with TWYNSTA. 2 DOSAGE AND ADMINISTRATION DOSAGE 2.1 GENERAL CONSIDERATIONS Telmisartan is an effective treatment of hypertension in once daily doses of 20-80 mg while amlodipine is effective in doses of 2.5-10 mg. Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of TWYNSTA tablets is 80/10 mg once daily. The adverse re Lestu allt skjalið