Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
FELODIPINE (UNII: OL961R6O2C) (FELODIPINE - UNII:OL961R6O2C)
Physicians Total Care, Inc.
FELODIPINE
FELODIPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
Felodipine is indicated for the treatment of hypertension. Felodipine may be used alone or concomitantly with other antihypertensive agents. Felodipine is contraindicated in patients who are hypersensitive to this product.
Felodipine extended-release tablets are supplied as follows: Felodipine extended-release tablets, 2.5 mg, are round, light green, film-coated, unscored, debossed MP 771 Felodipine extended-release tablets, 5 mg, are round, light orange, film-coated, unscored, debossed MP 772 Felodipine extended-release tablets, 10 mg, are round, brown, film-coated, unscored, debossed MP 773 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] PROTECT FROM LIGHT. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
FELODIPINE - FELODIPINE TABLET, FILM COATED FELODIPINE - FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE PHYSICIANS TOTAL CARE, INC. ---------- FELODIPINE EXTENDED-RELEASE TABLETS RX ONLY DESCRIPTION Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5- pyridinedicarboxylate. Its molecular formula is C H Cl NO and its structural formula is: Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture. Felodipine tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: felodipine tablets 2.5 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 5 mg — carnauba wax, D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 10 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. The USP drug release test # is pending. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Felodipine is a member of the dihydropyridine class of calcium channel antagonists (calcium channel blockers). It reversibly competes with nitrendipine and/or other calcium channel blockers for dihydropyridine binding sites, blocks voltage- Прочитать полный документ