Aprovasc® film coated tablet 150 mg/5 mg. Each tablet contains 150 mg irbesartan and 5 mg of amlodipine
Aprovasc® is indicated in the treatment of hypertension in adult patients in whom blood pressure is not
adequately controlled on irbesartan or amlodipine monotherapy.
Dosage
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
Irbesartan is a specific antagonist of angiotensin II receptor (AT1 subtype). Angiotensin
II is an important component of the renin-angiotensin system involved in the pathophysiology of hypertension and sodium homeostasis. Irbesartan does not require metabolic activation for its action.
Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting effects of angiotensin II, by selective antagonism of angiotensin II receptors (AT1 subtype) localized in vascular smooth muscle cells and in the adrenal cortex.
Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slowchannel blocker) that inhibits the entry of calcium ions and the transmembrane influx of these ions into both cardiac smooth muscle and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on the vascular smooth muscle. The precise mechanism by which amlodipine alleviates angina symptoms has not been determined, however, amlodipine reduces the total ischemic burden through the following two actions:
1) Amlodipine dilates the peripheral arterioles and thus reduces the total peripheral resistance (after load)
against which the heart works. Since the heart rate remains stable, this heart discharge reduces myocardial energy consumption and oxygen requirements;
2) Amlodipine mechanism of action probably involves also dilatation of the main arteries and coronary arterioles, both in ischemia and normal areas. This dilatation increases the oxygen supply to the myocardium in patients with coronary artery spasm (Prinzmetal's or variant angina).
