APROVEL

Country: Indonesia

Language: Indonesian

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

Active ingredient:

IRBESARTAN

Available from:

AVENTIS PHARMA - Indonesia

INN (International Name):

IRBESARTAN

Dosage:

150 MG

Pharmaceutical form:

TABLET SALUT SELAPUT

Units in package:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Manufactured by:

SANOFI WINTHROP INDUSTRIE - France

Authorization date:

2021-07-22

Summary of Product characteristics

BASED ON APROVEL-EU SMPC (22 APRIL 2021)
1
RANCANGAN LEAFLET
IRBESARTAN
COMPOSITION:
APROVEL 150 MG FILM COATED TABLETS
Each film coated tablet contains 150 mg irbesartan.
APROVEL 300 MG FILM COATED TABLETS
Each film coated tablet contains 300 mg irbesartan.
PHARMACEUTICAL FORM
150 MG FILM COATED TABLET.
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2872
engraved on the other side.
300 MG FILM COATED TABLET.
White to off-white, biconvex, and oval-shaped with a heart debossed on
one side and the number 2873
engraved on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•
Treatment of essential hypertension.
•
_To decrease micro and macro – albuminurea in hypertension patients
with nephropathic diabetic caused by _
_NIDDM (Non Insulin Dependent Diabetic Mellitus)._
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food. Aprovel at a
dose of 150 mg once daily generally provides a better 24 hours blood
pressure control than 75 mg. However,
initiation of therapy with 75 mg could be considered, particularly in
haemodialysed patients and in the elderly
over 75 years.
In patients insufficiently controlled with 150 mg once daily, the dose
of Aprovel can be increase to 300 mg, or
other antihypertensive agents can be added (see
_“Contraindications”_, _“Special warnings and precautions for _
_use”_, _ “Interaction with other medicinal products and other
forms of interaction”_ and “_Pharmacodynamic _
_properties”_). In particular, the addition of a diuretic such as
hydrochlorothiazide has been shown to have an
additive effect with Aprovel (see “_Interaction with other medicinal
products and other forms of interaction_”).
In hypertensive type 2 diabetic patients, therapy should be initiated
at 150 mg irbesartan once daily and titrated
up to 300 mg once daily as the preferred maintenance dose for
treatment of renal disease. The demonstration
of renal benefit o