FELODIPINEEXTENDED-RELEASE TABLETS- felodipine tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FELODIPINE (UNII: OL961R6O2C) (FELODIPINE - UNII:OL961R6O2C)

Available from:

Ranbaxy Pharmaceuticals Inc

INN (International Name):

FELODIPINE

Composition:

FELODIPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

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