APROVEL TABLET SALUT SELAPUT 150 MG

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

可用日期:

AVENTIS PHARMA - Indonesia

INN（国际名称）:

IRBESARTAN

剂量:

150 MG

药物剂型:

TABLET SALUT SELAPUT

每包单位数:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

厂商:

SANOFI-WINTHROP, FRANCE

授权日期:

2015-09-18

产品特点

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