Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IRBESARTAN
AVENTIS PHARMA - Indonesia
IRBESARTAN
150 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
SANOFI WINTHROP INDUSTRIE - France
2021-07-22
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 Baca dokumen lengkap