- Approval Id
- aef042ffc51888d1
- Drug Name
- APROVASC FILM COATED TABLET 300MG/5MG
- Product Name
- APROVASC FILM COATED TABLET 300MG/5MG
- Approval Number
- SIN16195P
- Approval Date
- 2021-05-14
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND METHOD OF ADMINISTRATION:</strong></p>
<p>The usual initial and maintenance dose of Aprovasc® is one tablet per day. Aprovasc® can be administered with or without food.<br>
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.</p>
<p>Treatment should be adjusted based on blood pressure response.</p>
<p><em>Pediatric patients:</em> The safety and efficacy of Aprovasc® has not been established in this population.</p>
<p><em>Elderly patients and patients with impaired renal function:</em> In general, no dosage reduction is necessary in elderly patients or patients with impaired renal function (regardless of the degree of impairment).</p>
<p><em>Patients with impaired hepatic function:</em> As the medicinal product contains amlodipine, Aprovasc® should be administered with caution in these patients (see Warnings – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Medicinal product for oral administration</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>THERAPEUTIC INDICATIONS:</strong></p>
<p>Treatment of essential hypertension.<br>
Aprovasc® is indicated in the treatment of hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS:</strong><br>
Due to the presence of both irbesartan and amlodipine, Aprovasc® is contraindicated in:</p>
<ul class="dash">
<li>Hypersensitivity to irbesartan, amlodipine, dihydropyridines or to any formulation component.</li>
<li>Shock (including cardiogenic shock).</li>
<li>Obstruction of the left ventricular outflow tract (e.g. clinically significant aortic stenosis).</li>
<li>Unstable angina (excluding Prinzmetal’s angina).</li>
<li>Haemodynamically unstable heart failure following an acute myocardial infarction.</li>
<li>Severe hypotension.</li>
<li>Pregnancy and lactation (see Warnings and Pregnancy and Lactation – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
<p>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).</p>
<p>Do not co-administer APROVASC® with angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetic nephropathy.</p>
- Atc Code
- C09DB05
- Atc Item Name
- irbesartan and amlodipine
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
