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:

Medsource Pharmaceuticals

INN (International Name):

FELODIPINE

Composition:

FELODIPINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Felodipine 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 and with different

Product summary:

Felodipine extended-release tablets USP, 2.5 mg are green colored film coated, circular shaped, biconvex tablets engraved with “G19” on one side of the tablet and plain on the other side. Felodipine extended-release tablets USP 5 mg are light pink colored film coated, circular shaped, biconvex tablets engraved with “G19” on one side of the tablet and “5” on the other side. Felodipine extended-release tablets USP 10 mg are brown colored film coated, circular shaped, biconvex tablets engraved with “G19” on one side of the tablet and “10” on the other side. Store at 20 o -25 o C (68 o -77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FELODIPINE- FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
MEDSOURCE PHARMACEUTICALS
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FELODIPINE EXTENDED-RELEASE TABLETS USP
RX ONLY
DESCRIPTION
Felodipine extended-release tablets USP are 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 USP 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 of felodipine for oral
administration. In addition to the active
ingredient felodipine, the felodipine extended-release tablets 2.5 mg,
5 mg and 10 mg contain the
following inactive ingredients: hydroxypropyl cellulose, hypromellose,
kaolin, lactose monohydrate,
microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil,
sodium stearyl fumarate, Opadry
Green 20B51525 (2.5 mg), Opadry Pink 20B84706 (5 mg) and Opadry Red
20B55372 (10 mg). Opadry
Green 20B51525 consists of hypromellose, hydroxypropyl cellulose,
macrogol, titanium dioxide, D&C
Yellow No. 10 Aluminium Lake, FD&C Blue No. 2 Aluminium Lake and
ferric oxide yellow. Opadry
Pink 20B84706 consists of hypromellose, hydroxypropyl cellulose,
macrogol, titanium dioxide, ferric
oxide red and ferric oxide yellow. Opadry Red 20B55372 consists of
hypromellose, hydroxypropyl
cellulose, macrogol, titanium dioxide, ferric oxide red and ferric
oxide yellow.
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
curr