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:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Name):

Felodipine

Composition:

Felodipine 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Felodipine extended-release tablets, USP 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 pharmacolog

Product summary:

  Felodipine extended-release tablets, USP 2.5 mg are white, round, unscored, film-coated tablets debossed with 'C369' on one side and plain on the other side. Bottles of 30's                NDC 59746-369-30 Bottles of 90's                NDC 59746-369-90 Bottles of 100's              NDC 59746-369-01 Bottles of 500's              NDC 59746-369-05  Bottles of 1000's            NDC 59746-369-10  Felodipine extended-release tablets, USP 5 mg are yellow, round, unscored, film-coated tablets debossed with 'C370' on one side and plain on the other side. Bottles of 30's                NDC 59746-370-30 Bottles of 90's                NDC 59746-370-90 Bottles of 100's              NDC 59746-370-01 Bottles of 500's              NDC 59746-370-05 Bottles of 1000's            NDC 59746-370-10 Felodipine extended-release tablets, USP 10 mg are blue, round, unscored, film-coated tablets debossed with 'C371' on one side and plain on the other side. Bottles of 30's                NDC 59746-371-30      Bottles of 90's                NDC 59746-371-90 Bottles of 100's              NDC 59746-371-01 Bottles of 500's              NDC 59746-371-05 Bottles of 1000's            NDC 59746-371-10 Store at 20° to 25°C (68° to 77°F); excursion permitted to 15° to 30°C ( 59° to 86°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. Manufactured by: Jubilant Generics Limited Roorkee - 247661, India Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA  Revised: 08/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FELODIPINE - FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
JUBILANT CADISTA PHARMACEUTICALS INC.
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FELODIPINE EXTENDED-RELEASE TABLETS, USP
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, USP. They are
available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine,
USP for oral administration. Inactive
ingredients are: Anhydrous Lactose, Microcrystalline Cellulose, Sodium
Alumino Silicate, Polyoxyl
40 Hydrogenated Castor Oil, Hypromellose, Hydroxypropyl Cellulose,
Propylgallate, Sodium Stearyl
Fumarate, Colloidal Silicon Dioxide, Titanium dioxide, Polyethylene
glycol 400. In addition the 5 mg
tablet strength contains Iron Oxide Yellow and the 10 mg tablet
strength contains FD&C Blue No. 2
Aluminum Lake and FD&C Red No. 40 Aluminum Lake.
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.
18
19
2
4
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_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 in