CATAPRES

Land: Indonesien

Sprache: Indonesisch

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

Wirkstoff:

CLONIDINE HYDROCHLORIDE

Verfügbar ab:

PYRIDAM FARMA TBK - Indonesia

INN (Internationale Bezeichnung):

CLONIDINE HYDROCHLORIDE

Dosierung:

0.075 MG

Darreichungsform:

TABLET

Einheiten im Paket:

DUS, 10 STRIP @ 10 TABLET

Hergestellt von:

DELPHARM REIMS - France

Berechtigungsdatum:

2021-06-23

Fachinformation

_1 _
Remarks: BLACK (Current CCDS 0067-03 – Safety Update); BLUE (Latest
Approved CCDS 0067-03 for
posology update)
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
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).
DISETUJUI OLEH BPOM: 26/04/2021
EREG100364VR12000487
EREG100364VR12000491
_2 _
Remarks: BLACK (Current CCDS 0067-03 – Safety Update); BLUE (Latest
Approved CCDS 0067-03 for
posology update)
CATAPRES sh