Source: Marketing Authorisation Holder Revision Year: 2023 Publisher: Sanofi-aventis de México, S.A. de C.V., Acueducto del Alto Lerma No. 2, Zona Industrial de Ocoyoacac, C. P. 52740 Ocoyoacac, Edo. de México
Aprovasc film coated tablet.
| Pharmaceutical Form |
|---|
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Film coated tablet 150 mg/5 mg: White, oval shaped film coated tablets with ‘150/5’ debossed on one side and plain on other side. Film coated tablet 300 mg/5 mg: Yellow, oval shaped film coated tablets with ‘300/5’ debossed on one side and plain on other side. Film coated tablet 300 mg/10 mg: White, oval shaped film coated tablets with SNAP TAB scoreline on one side and plain on other side. The tablet can be divided into equal halves. |
Aprovasc film coated tablet 150 mg/5 mg: Each tablet contains 150 mg irbesartan and 5 mg of amlodipine (7 mg of amlodipine besilate).
Aprovasc film coated tablet 300 mg/10 mg: Each tablet contains 300 mg irbesartan and 10 mg of amlodipine (14 mg of amlodipine besilate).
Aprovasc film coated tablet 300 mg/5 mg: Each tablet contains 300 mg irbesartan and 5 mg of amlodipine (7 mg of amlodipine besilate).
| Active Ingredient | Description | |
|---|---|---|
| Amlodipine |
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. |
|
| Irbesartan |
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. |
|
| Irbesartan and Amlodipine |
The pharmacodynamic properties of each drug, irbesartan and amlodipine, provide an additive antihypertensive effect when administered in combination compared to the effect of each drug administered separately. Irbesartan is a specific angiotensin II receptor antagonist (AT1 subtype) and amlodipine is a dihydropyridine calcium antagonist. Both AT1 receptor antagonists and calcium channel blockers lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of angiotensin II vasoconstriction are complementary mechanisms. |
| List of Excipients |
|---|
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Aprovasc film coated tablet 150 mg/5 mg: Cellulose microcrystalline PH 101, Cellulose microcrystalline PH 112, Croscarmellose sodium, Hypromellose, silicon dioxide, magnesium stearate, macrogol 400, titanium dioxide, purified water – trace. Aprovasc film coated tablet 300 mg/10 mg: Cellulose microcrystalline PH 101, Cellulose microcrystalline PH 112, Croscarmellose sodium, Hypromellose, silicon dioxide, magnesium stearate, macrogol 400, titanium dioxide, purified water – trace. Aprovasc film coated tablet 300 mg/5 mg: Cellulose microcrystalline PH 101, Cellulose microcrystalline PH 112, Croscarmellose sodium, Hypromellose, silicon dioxide, magnesium stearate, macrogol 400, titanium dioxide, iron oxide yellow, macrogol 8000, purified water – trace. |
Sanofi-aventis de México, S.A. de C.V., Acueducto del Alto Lerma No. 2, Zona Industrial de Ocoyoacac, C. P. 52740 Ocoyoacac, Edo. de México
| Drug | Countries | |
|---|---|---|
| APROVASC | Ecuador, Mexico, Tunisia, South Africa |
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