COAPROVEL

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

IRBESARTAN, HYDROCHLOROTHIAZIDE

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

IRBESARTAN, HYDROCHLOROTHIAZIDE

Dosis:

300 MG /12.5 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Diproduksi oleh:

SANOFI WINTHROP INDUSTRIE - France

Tanggal Otorisasi:

2021-07-22

Karakteristik produk

COMPOSITION
COAPROVEL 150 MG /12.5 MG FILM COATED TABLETS
Each film-coated tablet contains 150 mg irbesartan and 12.5 mg
hydrochlorothiazide.
COAPROVEL 300 MG/12.5 MG FILM COATED TABLETS
Each film-coated tablet contains 300 mg irbesartan and 12.5 mg
hydrochlorothiazide.
PHARMACEUTICAL FORM
150 MG/12.5 MG FILM COATED TABLET
Film-coated tablet: Peach, biconvex, oval-shaped, with a heart
debossed on one side and the
number «2875» engraved on the other side.
300 MG/12.5 MG FILM COATED TABLET
Film-coated tablet: Peach, biconvex, oval-shaped, with a heart
debossed on one side and the
number «2876» engraved on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This fixed dose combination is indicated in patients whose blood
pressure is not adequately
controlled on irbesartan or hydrochlorothiazide alone.
This fixed dose combination is also indicated as initial treatment
when hypertension is severe
and rapid control of blood pressure (within days to weeks) is of
primary clinical importance (see
“_Pharmacodynamic Properties_”).
POSOLOGY AND METHOD OF ADMINISTRATION
CoAprovel can be taken once daily, with or without food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be
recommended.
When clinically appropriate direct change from monotherapy to the
fixed combinations may be
considered:
•
CoAprovel 150 mg/12.5 mg may be administered in patients whose blood
pressure is not
adequately controlled with hydrochlorothiazide or irbesartan 150 mg
alone;
•
CoAprovel 300 mg/12.5 mg may be administered in patients
insufficiently controlled by
irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
•
CoAprovel 300 mg/25 mg may also be administered in patients
insufficiently controlled by
CoAprovel 300 mg/12.5 mg.
Doses
higher
than
300 mg irbesartan/25 mg hydrochlorothiazide
once
daily
are
not
recommended.
When necessary, CoAprovel may be administered with another
antihypertensive medicinal
product _(_see “_Interaction with other medici