FELODIPINE tablet film coated extended release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Richmond Pharmaceuticals, Inc.

ИНН (Международная Имя):

FELODIPINE

состав:

FELODIPINE 2.5 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

FELODIPINE- FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
RICHMOND PHARMACEUTICALS, INC.
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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 light yellow to yellow 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 of felodipine, USP for oral
administration. In addition to the
active ingredient felodipine, the tablets contain the following
inactive ingredients: felodipine extended-
release 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 extended-
release 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
extended-release 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
dihydropyri