Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
St Marys Medical Park Pharmacy
AMLODIPINE BESYLATE
AMLODIPINE 10 mg
ORAL
PRESCRIPTION DRUG
Amlodipine Besylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. They may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine Besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. They may be used as monotherapy or in combination with other antianginal drugs. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.
Amlodipine besylate–10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side and 239 on the other and supplied as follows: NDC: 60760-0239-30 bottles of 30 NDC: 60760-0239-90 bottles of 90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET ST MARYS MEDICAL PARK PHARMACY ---------- AMLODIPINE BESYLATE TABLETS RX ONLY DESCRIPTION Amlodipine besylate, USP is a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2- aminoethoxy)methyl]4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C H CIN O •C H O S, and its structural formula is: Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, 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 compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual ra Läs hela dokumentet