導脈順緩釋膠囊2.5毫克

国家: 台湾

语言: 中文

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

资料单张 资料单张 (PIL)
12-05-2020
公众评估报告 公众评估报告 (PAR)
26-03-2020

有效成分:

ISRADIPINE

可用日期:

臺灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)

ATC代码:

C08CA03

药物剂型:

持續性藥效膠囊劑

组成:

ISRADIPINE (2412402100) 2.5MG

每包单位数:

盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

NOVARTIS FARMACEUTICA S.A. RONDA SANTA MARIA,158,08210 BARBERA DEL VALLES BARCELONA,SPAIN ES

治疗领域:

isradipine

疗效迹象:

高血壓

產品總結:

註銷日期: 2016/02/15; 註銷理由: 自請註銷; 有效日期: 2016/08/02; 英文品名: DYNACIRC SRO CAPSULES 2.5MG

授权状态:

已註銷

授权日期:

1996-08-02

资料单张

                                DYNACIRC SRO

Selective
calcium
channel
blockers
with
mainly
vascular
effects, dihydropyridine derivatives.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
2.5 mg and 5 mg modified release capsules (SRO capsules)
for oral administration.
ACTIVE SUBSTANCE
Isradipine
Certain dosage strengths and dosage forms may not be
available in all countries.
EXCIPIENTS
DYNACIRC 2.5 MG SRO CAPSULES: Cellulose, microcrystalline;
cetyl palmitate; gelatine; iron oxide, black (only for Dynacirc
2.5
mg
SRO);
iron
oxide,
yellow;
magnesium
stearate;
hypromellose
shellac;
silica,
colloidal
anhydrous;
titanium
dioxide.
DYNACIRC 5 MG SRO CAPSULES: Cellulose, microcrystalline;
cetyl palmitate; gelatine; iron oxide, red (only for Dynacirc 5
mg
SRO);
iron
oxide,
yellow;
magnesium
stearate;
hypromellose
shellac;
silica,
colloidal
anhydrous;
titanium
dioxide.
INDICATIONS
Treatment of hypertension.
DOSAGE AND ADMINISTRATION
DYNACIRC SRO CAPSULES 2.5MG
The recommended dosage in mild to moderate hypertension
is 2.5 mg (one tablet) twice a day or one 5 mg SRO capsule
once a day.
DYNACIRC SRO CAPSULES 5MG
The recommended dosage in mild to moderate hypertension
is one 5 mg SRO capsule once a day.
Dynacirc SRO capsules must be swallowed whole.
If one 5 mg SRO capsule once a day is not sufficiently
effective, after at least 4 weeks of treatment, the addition of
another antihypertensive agent is recommended (preferably a
thiazide
diuretic,
ACE
inhibitor
or
beta-blocker).
Dynacirc
SRO
can
also
be
added
to
existing
antihypertensive
treatment. When Dynacirc SRO is given concurrently with
cimetidine, the dose of Dynacirc / Dynacirc SRO should be
reduced by 50% (see section INTERACTIONS).
SPECIAL POPULATIONS
Geriatrics, renal impairment and hepatic impairmentIn elderly
patients or in patients with impaired hepatic or renal function,
a more suitable starting dose is 1.25 mg (½ tablet) twice a
day or one 2.5 mg SRO capsule once a day.
Pediatrics
Well designed clinical trials of calcium channel blockers in
children
have
not
been
performed.
Although
limit
                                
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