দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
Amlodipine besylate (UNII: 864V2Q084H) (Amlodipine - UNII:1J444QC288)
Synthon Pharmaceuticals, Inc.
Amlodipine Besylate
TABLET
2.5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine besylate is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Amlodipine besylate is indicated for the treatment of chronic stable angina. Amlodipine besylate may be used alone or in combination with other antianginal agents. Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs. Amlodipine besylate is contraindicated in patients with known sensitivity to amlodipine.
Amlodipine besylate tablets, 2.5 mg , equivalent to 2.5 mg of amlodipine per tablet, are white to off-white, triangular, biconvex, unscored tablet, one side engraved "ADP bes" and the other side engraved with "2.5" and supplied as follows: Amlodipine besylate tablets, 5 mg , equivalent to 5 mg of amlodipine per tablet, are white to off-white, oblong, biconvex, unscored tablet, one side engraved with "ADP bes" and the other side engraved with "5" and supplied as follows: Amlodipine besylate tablets, 10 mg , equivalent to 10 mg of amlodipine per tablet, are white to off-white, round, biconvex, unscored tablet, one side engraved with "ADP bes" and the other side engraved with "10" and supplied as follows: Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature. Dispense in tight, light-resistant containers (USP).
AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET SYNTHON PHARMACEUTICALS, INC. ---------- AMLODIPINE BESYLATE TABLETS PRESCRIBING INFORMATION DESCRIPTION Amlodipine besylate is a besylate salt of amlodipine, and is a long-acting calcium channel blocker. Amlodipine besylate monohydrate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate monohydrate. Its molecular formula is C H ClN O •C H SO •H O and its structural formula is: Amlodipine besylate monohydrate is a white crystalline powder with a molecular weight of 585.07. It is slightly soluble in water, ethanol, acetone and 2-propanol and soluble in N, N-dimethylformamide and dimethylsulfoxide. Amlodipine besylate tablets are formulated as white to off-white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected _in vitro_ but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized co সম্পূর্ণ নথি পড়ুন