FELODIPINE tablet, film coated FELODIPINE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

FELODIPINE

Composition:

FELODIPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FELODIPINE - FELODIPINE TABLET, FILM COATED
FELODIPINE - FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, 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 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-