FELODIPINE- 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

FELODIPINE

Composition:

FELODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Felodipine extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes an

Product summary:

Felodipine extended-release tablets are supplied as follows: Felodipine extended-release tablets, 5 mg, are round, light orange, film-coated, unscored, debossed MP 772 Bottles of 30 (NDC 55289-306-30), Bottles of 90 (NDC 55289-306-90). 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, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, 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 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
dihydropyridin