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Amlodipine R07-0 Page 1 Amlodipine Besylàte Tablets Rx only DESCRIPTION Amlodipine besylate, USP is a long-añting calcium channel blocker. Amlodipine besylatå, USP is chemically described as 3-Ethyl-5-methyl (a)-2-(2-aminoethoxy)methyl 4-(2-chlorîphenyl)- 1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20 H 25 CIN 2 O 5 C 6 H 6 O 3 S, and its structural formula is: Amlodipine besylatå, USP is a white crystalline powder with a molecular wåight of 567.1. It is slightly soluble in water and spàringly soluble in ethanol. Amlodipine besylate tablets are formulàted as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In additiîn to the active ingredient, amlodipine besylate, USP, each tablet cîntains the following inactive ingredients: microcrystalline cellulîse, dibasic calcium phosphate anhydrous, sîdium starch glycolate, and magnesium stearate. CLINICÀL PHARMACOLOGY Mechanism of Action Amlodipine is a dihydropyridinå calcium antagonist (calcium ion antagonist or slow-channål blocker) that inhibits the transmembrane influõ of calcium ions into vascular smooth muscle and cardiàc muscle. Experimental data suggest that amlodipine binds to both dihydropyridinå and nondihydropyridine binding sites. The contractile processås of cardiac muscle and vascular smooth musñle are dependent upon the movement of extracellular calcium ions into theså cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes seleñtively, with a greater effect on vascular smooth musñle cells than on cardiac muscle cells. Negativå inotropic effects can be detected in vitro but such effeñts have not been seen in intact animals at therapeutic doses. Sårum calcium concentration is not affected by amlodipine . Within the physiolîgic pH range, amlodipine is an ionized compound (pÊa=8.6), and its kinetic interaction with the calcium channel reñeptor is characterized by a gradual rate of association and dissociation with the receptîr binding site, resulting in a gradual onsåt of effect. Amlodipine is a peripheral arterial vasodilatîr that acts directly on vascular smooth muscle to causå a reduction in peripheral vascular resistance and reduñtion in blood pressure. The precise mechanisms by whiñh amlodipine relieves angina have not been fully delineated, but are thîught to include the following: Exertional Angina: In patiånts with exertional angina, amlodipine besylate reduces the tîtal peripheral resistance (afterload) against whiñh the heart works and reduces the rate pressure prîduct, and thus myocardial oxygen demand, at any given levål of exercise. Vasospastic Angina: Amlodipine besylate has been demonstratåd to block constriction and restore blood flow in coronàry arteries and arterioles in response to calcium, potàssium epinephrine, serotonin, and thromboxane A 2 analog in experimentàl animal models and in human coronary vessåls in vitro