CATAPRES

Country: 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:

75 MCG

Фармацеутски облик:

TABLET

Јединице у пакету:

DUS, 2 PLASTIC BAG @ 15 KG (155.000-160.000 TABLET)

Произведен од:

DELPHARM REIMS - France

Датум одобрења:

2020-01-02

Карактеристике производа

_1 _
CATAPRES
®
Clonidine hydrochloride
COMPOSITION
1 tablet contains
0.075 mg or 0.150 mg
2,6-dichloro-N-2-imidazolidinylidenebenzenamine hydrochloride
(= clonidine hydrochloride)
Excipients
Tablets
:
Lactose monohydrate, calcium hydrogen phosphate anhydrous, maize
starch dried, silica
colloidal anhydrous, povidone, starch soluble, stearic 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.
_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.
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 sinus syndrome or AV block of 2nd or 3rd
degree.
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.
TABLETS
As an initial daily dose in mild to moderate forms of hypertension,
0.075 mg to 0.150 mg
twice daily are sufficient in most cases.
After a period of 2 - 4 weeks the dose may be increased if necessary
until the desired
response is achieved.
Usually doses above 0.6 mg per day do not result in a further marked
drop in blood pressure.
In severe hypertension it might be necessary to increase the single
dose further to 0.3 mg;
this could be repeated up to three times daily (0.9 mg).
Remarks: Black (Current CCDS 0067-03 – Safety Update); Blue (Lat