MedPath
HSA Approval

APROVASC FILM COATED TABLET 150MG/5MG

SIN16194P

APROVASC FILM COATED TABLET 150MG/5MG

APROVASC FILM COATED TABLET 150MG/5MG

May 14, 2021

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence HolderSANOFI-AVENTIS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET, FILM COATED

**DOSAGE AND METHOD OF ADMINISTRATION:** The usual initial and maintenance dose of Aprovasc® is one tablet per day. Aprovasc® can be administered with or without food. Aprovasc® should be administered in patients whose blood pressure is not adequately controlled on monotherapy with irbesartan or amlodipine or for continuation of therapy for patients receiving irbesartan and amlodipine as separate tablets. Dose should be determined on a case-by-case basis, based on patient response to therapy with the individual components and the desired antihypertensive response. The maximum recommended dose with Aprovasc® is 300 mg/10 mg per day. Treatment should be adjusted based on blood pressure response. _Pediatric patients:_ The safety and efficacy of Aprovasc® has not been established in this population. _Elderly patients and patients with impaired renal function:_ In general, no dosage reduction is necessary in elderly patients or patients with impaired renal function (regardless of the degree of impairment). _Patients with impaired hepatic function:_ As the medicinal product contains amlodipine, Aprovasc® should be administered with caution in these patients (see Warnings – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Medicinal product for oral administration

ORAL

Medical Information

**THERAPEUTIC INDICATIONS:** Treatment of essential hypertension. Aprovasc® is indicated in the treatment of hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy.

**CONTRAINDICATIONS:** Due to the presence of both irbesartan and amlodipine, Aprovasc® is contraindicated in: - Hypersensitivity to irbesartan, amlodipine, dihydropyridines or to any formulation component. - Shock (including cardiogenic shock). - Obstruction of the left ventricular outflow tract (e.g. clinically significant aortic stenosis). - Unstable angina (excluding Prinzmetal’s angina). - Haemodynamically unstable heart failure following an acute myocardial infarction. - Severe hypotension. - Pregnancy and lactation (see Warnings and Pregnancy and Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Do not co-administer APROVASC® with medications containing aliskiren in patients with diabetes or with moderate to severe renal impairment (Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2). Do not co-administer APROVASC® with angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetic nephropathy.

C09DB05

irbesartan and amlodipine

Manufacturer Information

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI AVENTIS DE MEXICO S.A. DE C.V.

Active Ingredients

IRBESARTAN

150mg

Irbesartan

AMLODIPINE BESILATE eqv Amlodipine

5mg

Amlodipine

Documents

Package Inserts

Aprovasc Film Coated Tablet PI.pdf

Approved: June 1, 2023

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.