COAPROVEL

国家: 印度尼西亚

语言: 印度尼西亚文

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

有效成分:

IRBESARTAN, HYDROCHLOROTHIAZIDE

可用日期:

AVENTIS PHARMA - Indonesia

INN（国际名称）:

IRBESARTAN, HYDROCHLOROTHIAZIDE

剂量:

150 MG /12.5 MG

药物剂型:

TABLET SALUT SELAPUT

每包单位数:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

厂商:

SANOFI WINTHROP INDUSTRIE - France

授权日期:

2021-07-22

产品特点

BASED ON COAPROVEL-EU SMPC (22 APRIL 2021)
1
RANCANGAN LEAFLET
IRBESARTAN /HYDROCHLOROTIAZIDE
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
Posology
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 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 adm