APROVEL

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

IRBESARTAN

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

IRBESARTAN

Dosis:

300 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:
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. 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 of Aprovel in hypertensive type
2 diabetic patients is based on studies where irbesartan was used in
addition to other antihypertensive agents, as needed, to reach target
blood pressure (see_ _“_Pharmacodynamic properties_”).
Special Populations
_R