Land: Südafrika
Sprache: Englisch
Quelle: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
AMLODAC 5 TABLETS AMLODAC 10 TABLETS SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): AMLODAC 5 TABLETS AMLODAC 10 TABLETS COMPOSITION: Each tablet contains amlodipine besylate equivalent to 5 mg or 10 mg amlodipine . PHARMACOLOGICAL CLASSIFICATION: A 7.1 Vasodilators, hypotensive medicines. PHARMACOLOGICAL ACTION: Amlodipine is a dihydropyridine calcium channel blocker. It inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle without affecting serum calcium concentrations. Direct relaxation of vascular smooth muscle forms the basis of the antihypertensive action. In angina pectoris, amlodipine acts as a peripheral arteriolar vasodilator resulting in a reduction in total peripheral resistance (afterload). Myocardial energy and oxygen requirements are reduced. Amlodipine exerts its activity by binding to the dihydropyridine binding sites. It exerts minimal action on cardiac conduction, contraction and heart rate. Pharmacokinetics Complete absorption of amlodipine is slow following oral administration with peak plasma levels being attained after 6 to 12 hours. Amlodipine has a bioavailability of about 64% and a plasma elimination half-life of 35 to 50 hours, allowing for once-daily oral dosing. Steady state plasma concentrations are achieved after 7 to 8 days of consecutive dosing. The volume of distribution is about 20/kg. Metabolism is via the liver and is extensive with less than 10% of amlodipine appearing unchanged in the urine. Metabolites are inactive and primarily (up to 60%) excreted via the kidney. INDICATIONS: AMLODAC is indicated for the • Treatment of angina pectoris. • Treatment of mild to moderate hypertension, alone or in combination with other antihypertensives. CONTRA-INDICATIONS: Hypersensitivity to any Lesen Sie das vollständige Dokument