CATAPRES

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

CLONIDINE HYDROCHLORIDE

Tersedia dari:

PYRIDAM FARMA TBK - Indonesia

INN (Nama Internasional):

CLONIDINE HYDROCHLORIDE

Dosis:

0.15 MG

Bentuk farmasi:

INJEKSI

Unit dalam paket:

DUS, 10 AMPUL @ 1 ML

Diproduksi oleh:

BOEHRINGER INGELHEIM ESPANA - Spain

Tanggal Otorisasi:

2021-04-22

Karakteristik produk

_1 _
Remarks : BLACK (Current CCDS 0067-03 – Safety Udpate); BLUE
(Proposed as update CCDS 0067-03 for
Posology)
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.
DISETUJUI OLEH BPOM: 25/03/2021
EREG100364VR12000486
_2 _
Remarks : BLACK (Current CCDS 0067-03 – Safety Udpate); BLUE
(Proposed as update CCDS 0067-03 for
Posology)
CONTRAINDICATIONS
CATAPRES
®
should
not
be
used
in
patients
with
known
hypersensitivity
to
the
active
i