Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
FELODIPINE (UNII: OL961R6O2C) (FELODIPINE - UNII:OL961R6O2C)
Ranbaxy Pharmaceuticals Inc
FELODIPINE
FELODIPINE 2.5 mg
ORAL
PRESCRIPTION DRUG
Felodipine extended-release tablets are indicated for the treatment of hypertension. Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents. Felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product.
No.3584 — Felodipine extended-release tablets, 2.5 mg, are sage green, round convex tablets, with code 450 on one side and PLENDIL on the other. They are supplied as follows: NDC 63304-435-01 bottles of 100 No.3585 — Felodipine extended-release tablets, 5 mg, are light red-brown, round convex tablets, with code 451 on one side and PLENDIL on the other. They are supplied as follows: NDC 63304-436-01 bottles of 100 No.3586 — Felodipine extended-release tablets, 10 mg, are red-brown, round convex tablets, with code 452 on one side and PLENDIL on the other. They are supplied as follows: NDC 63304-437-01 bottles of 100 Store below 30°C (86°F). Keep container tightly closed. Protect from light. PLENDIL is a trademark of the Astrazeneca group of companies © Astrazeneca 2008 Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257, USA By: Merck & Co., Inc Whitehouse Station, NJ, 08889, USA 9874900 31427-00 Rev. 07/08
New Drug Application
FELODIPINEEXTENDED-RELEASE TABLETS- FELODIPINE TABLET, EXTENDED RELEASE RANBAXY PHARMACEUTICALS INC ---------- 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 empirical 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 extended-release tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg at felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: Felodipine extended- release tablets 2.5 mg — hydroxypropyl cellulose, lactose, FD&C Blue 2, sodium stearyl fumarate, titanium dioxide, yellow iron oxide, and other ingredients. Felodipine extended-release tablets 5 mg and 10 mg—cellulose, red and yellow oxide, lactose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide, and other ingredients. 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-dependent Ca currents in vascular smooth muscle and cultured rabbit atrial cells, and blocks potassium-induced contracture of the rat portal vein. _In vitro_ studies show that the effects of felodipine on contractile processes are selective, with greater effects on vascular smooth muscle than cardiac muscle. Negative inotropic effects can be detected _in_ _vitro_, but such effects have not been seen in intact animals. The effect of felodipine on blood pressure is principally a conseq Perskaitykite visą dokumentą