CATAPRES

Држава: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активни састојак:

CLONIDINE HYDROCHLORIDE

Доступно од:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Међународно име):

CLONIDINE HYDROCHLORIDE

Дозирање:

150 MCG/ML

Фармацеутски облик:

CAIRAN INJEKSI

Јединице у пакету:

DUS, 10 AMPUL @ 1 ML

Произведен од:

BOEHRINGER INGELHEIM ESPANA SA, SPAIN

Датум одобрења:

2016-12-19

Карактеристике производа

_1 _
CATAPRES
®
Clonidine hydrochloride
COMPOSITION
1 ampoule of 1 ml contains
0.150 mg
2,6-dichloro-N-2-imidazolidinylidenebenzenamine hydrochloride
(= clonidine hydrochloride)
Excipients:
ampoules:
Sodium chloride, hydrochlorid acid
INDICATIONS
CATAPRES
®
is indicated in the treatment of hypertension. CATAPRES
®
may be employed
alone or concomitantly with other antihypertensive agents.
For the treatment of hypertensive crises, slow parenteral
administration is especially suitable
due to the rapid onset of action.
DOSAGE AND ADMINISTRATION
Treatment of hypertension requires regular medical supervision.
The dose of CATAPRES
®
must be adjusted according to the patient's individual blood
pressure response.
AMPOULES
Subcutaneous or i.m. injection of an ampoule containing 0.150 mg
CATAPRES
®
should only
be carried out in patients in a lying position.
A dosage of 0.2 mcg/kg/minute is recommended for i.v. infusion. The
rate of infusion should
not exceed 0.5 mcg/kg/minute to avoid transient blood pressure
increase. No more than
0.15 mg should be used per infusion.
If necessary, ampoules can be administered parenterally up to 4 times
daily.
This medicinal product contains less than 1 mmol sodium (23 mg) per
ampoule, i.e.
essentially ‘sodium-free’.
RENAL INSUFFICIENCY
Dosage must be adjusted
-
according to the individual antihypertensive response which can show
high variability
in patients with renal insufficiency
-
according to the degree of renal impairment
Careful monitoring is required. Since only a minimal amount of
clonidine is removed during
routine haemodialysis, there is no need to give supplemental clonidine
following dialysis.
Remarks : BLACK (Current CCDS 0067-03 – Safety Udpate); BLUE
(Proposed as update CCDS 0067-03 for
Posology)
DISETUJUI OLEH BPOM : 05/05/2020
214242801
_2 _
CONTRAINDICATIONS
CATAPRES
®
should not be used in patients with known hypersensitivity to the
active
ingredient or other components of the product, and in patients with
severe bradyarrhythmia
resulting from either sick sin