Land: Sydafrika
Sprog: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ALMADIN 5 mg (Tablets) ALMADIN 10 mg (Tablets) SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): ALMADIN 5 mg (Tablets) ALMADIN 10 mg (Tablets) COMPOSITION: ALMADIN (amlodipine besylate) is a dihydropyridine derivative, and has the following chemical name: 3-ethyl 5- methyl 2-(2-aminoethoxy-methyl)-4-(2-chlorophenyl)-1, 4-dihydro-6-methyl-3,5-pyridine-dicarboxylate benzenesulphonate. Each ALMADIN 5 mg tablet contains amlodipine besylate equivalent to 5 mg active amlodipine base. Each ALMADIN 10 mg tablet contains amlodipine besylate equivalent to 10 mg active amlodipine base. PHARMACOLOGICAL CLASSIFICATION: A 7.1 VasodiIators, 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-Iife 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 20L/kg. Metabolism is via the liver and is extensive, with less tha Læs hele dokumentet