DILATREND TABLET 25 mg

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

CARVEDILOL

Доступна з:

DKSH SINGAPORE PTE. LTD.

Код атс:

C07AG02

Дозування:

25 mg

Фармацевтична форма:

TABLET

Склад:

CARVEDILOL 25 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

Prescription Only

Виробник:

DELPHARM MILANO S.R.L.

Статус Авторизація:

ACTIVE

Дата Авторизація:

1993-05-05

інформаційний буклет

KOEPCKE.PUBLISHING
DRAFT (DATE) 24.05.2018 [13:30 uhr] (2)
COLOURS pantone black
DIMENSIONS 210 x 600 mm
MATERIAL NUMBER 90001794/10 local
FONT SIZE 7,5 pt
DILATREND
®
Carvedilol
ALPHA (Α) AND BETA (Β) ADRENERGIC RECEPTOR BLOCKING AGENTS
1. DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Alpha (α) and beta (β) adrenergic receptor blocking agents
ATC CODE: C07AG02
1.2 TYPE OF DOSAGE FORM
Tablets
The tablets are uncoated, round, and biconvex with a bilateral
scoreline, and either
pale pink (3.125 mg), yellow (6.25 mg), pale peach (12.5 mg) or white
(25 mg).
1.3 ROUTE OF ADMINISTRATION
Oral.
1.4 STERILE/RADIOACTIVE STATEMENT
Not applicable.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ carvedilol.
Tablets
One 3.125 mg tablet contains 3.125 mg carvedilol.
One 6.25 mg tablet contains 6.25 mg carvedilol.
One 12.5 mg tablet contains 12.5 mg carvedilol.
One 25 mg tablet contains 25 mg carvedilol.
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
_Hypertension_
Dilatrend is indicated for the management of essential hypertension.
It can be used alone or in combination with other antihypertensive
agents (e.g.
calcium channel blockers, diuretics).
_Treatment of angina pectoris_
_Treatment of symptomatic chronic heart failure_
Dilatrend is indicated for the treatment of symptomatic chronic heart
failure (CHF)
to reduce mortality and cardiovascular hospitalisations, improve
patient well-being
and slow the progression of the disease.
Dilatrend may be used as adjunct to standard therapy, but may also be
used in those
patients unable to tolerate an ACE inhibitor, or those who are not
receiving digitalis,
hydralazine or nitrate therapy.
2.2 DOSAGE AND ADMINISTRATION
_Method of administration_
The tablets are to be swallowed with sufficient fluid.
_Duration of treatment_
Treatment with carvedilol is a long-term therapy. As with all
β-blockers, treatment
should not be stopped abruptly but rather gradually reduced at weekly
intervals.
This is particularly important in the case of patients with
co

Характеристики продукта

1
DILATREND®
Carvedilol
ALPHA (Α) AND BETA (Β) ADRENERGIC RECEPTOR BLOCKING AGENTS
1. DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Alpha (α) and beta (β) adrenergic receptor blocking agents
ATC CODE:
C07AG02
1.2 TYPE OF DOSAGE FORM
Tablets
The tablets are uncoated, round, and biconvex with a bilateral score,
and either
light brown (12.5 mg) or white (25 mg).
1.3 ROUTE OF ADMINISTRATION
Oral.
1.4 STERILE/RADIOACTIVE STATEMENT
Not applicable.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION_ _
_Active ingredient:_
carvedilol.
Tablets
One 12.5 mg tablet contains 12.5 mg carvedilol.
One 25 mg tablet contains 25 mg carvedilol.
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
_Hypertension _
Dilatrend is indicated for the management of essential hypertension
_. _
It can be used alone or in combination with other antihypertensive
agents (e.g.
calcium channel blockers, diuretics).
_Angina pectoris _
Carvedilol
has
demonstrated
anti-ischemic
and
anti-anginal
properties
in
patients with coronary heart disease.
_Symptomatic chronic heart failure _
2
Dilatrend is indicated for the treatment of symptomatic chronic heart
failure
(CHF) to reduce mortality and cardiovascular hospitalisations, improve
patient
well-being and slow the progression of the disease.
Dilatrend may be used as adjunct to standard therapy, but may also be
used in
those patients unable to tolerate an ACE inhibitor, or those
who are not
receiving digitalis, hydralazine or nitrate therapy.
2.2 DOSAGE AND ADMINISTRATION
_Method of administration _
The tablets are to be swallowed with sufficient fluid.
_Duration of treatment _
Treatment
with
carvedilol
is
a
long-term
therapy.
As with
all
β-blockers,
treatment should not be stopped abruptly but rather gradually reduced
at weekly
intervals. This is particularly important in the case of patients with
concomitant
coronary heart disease.
_Hypertension _
The recommended dose for initiation of therapy is 12.5 mg once a day
for the
first 2 days. Thereafter, the recommended dosage is 25 mg once a day.