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:

Mylan 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, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal 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 one 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, USP are available containing 2.5 mg, 5 mg or 10 mg of felodipine, USP. The 2.5 mg tablet is a white film-coated, round, unscored tablet debossed with M on one side of the tablet and F11 on the other side. They are available as follows: NDC 0378-5011-01 bottles of 100 tablets NDC 0378-5011-05 bottles of 500 tablets The 5 mg tablet is a yellow film-coated, round, unscored tablet debossed with M on one side of the tablet and F12 on the other side. They are available as follows: NDC 0378-5012-01 bottles of 100 tablets NDC 0378-5012-05 bottles of 500 tablets The 10 mg tablet is a blue film-coated, round, unscored tablet debossed with M on one side of the tablet and F13 on the other side. They are available as follows: NDC 0378-5013-01 bottles of 100 tablets NDC 0378-5013-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED FEBRUARY 2013 FLDP:R3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FELODIPINE- FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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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, USP 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 acetone and in methanol;
very slightly soluble in heptane.
Felodipine is a racemic mixture.
Felodipine extended-release tablets, USP 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. Inactive ingredients
are: butylated hydroxyanisole, butylated hydroxytoluene, colloidal
silicon dioxide, hypromellose,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, sodium stearyl fumarate and
titanium dioxide. In addition, the 5 mg tablet strength contains D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake and
the 10 mg tablet
strength contains FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6
Aluminum Lake.
_Meets USP Dissolution Test 3._
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 inta