倍必康平錠80/10毫克

מדינה: טייוואן

שפה: סינית

מקור: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

מרכיב פעיל:

TELMISARTAN;;AMLODIPINE BESILATE

זמין מ:

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)

קוד ATC:

C09DB04

טופס פרצבטיות:

錠劑

הרכב:

TELMISARTAN (2408005600) MG; AMLODIPINE BESILATE (2412402220) eq. to 10mg free baseMG

יחידות באריזה:

鋁箔盒裝

סיווג:

製　劑

סוג מרשם:

須由醫師處方使用

תוצרת:

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG BINGER STRASSE 173, D-55216 INGELHEIM AM RHEIN, GERMANY DE

איזור תרפויטי:

telmisartan and amlodipine

סממני תרפויטית:

治療高血壓，此複方藥品不適用於起始治療。

leaflet_short:

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

מצב אישור:

已註銷

תאריך אישור:

2011-09-14

עלון מידע

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