FELODIPINE tablet, extended release 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:

Par Pharmaceutical, 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 pharmacologic c

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 round, green tablet, debossed with “E 136” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets                NDC 0603-3581-21 Bottles of 500 tablets                NDC 0603-3581-28 The 5 mg tablet is a round, pink tablet, debossed with “E 137” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets                NDC 0603-3582-21 Bottles of 500 tablets                NDC 0603-3582-28 The 10 mg tablet is a red film-coated, round tablet with “E 138” debossed on one side and a plain face on the other side. They are available as follows: Bottles of 100 tablets                NDC 0603-3583-21 Bottles of 500 tablets                NDC 0603-3583-28 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. Manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5 Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 01/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FELODIPINE- FELODIPINE TABLET, EXTENDED RELEASE
FELODIPINE- FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
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FELODIPINE EXTENDED-RELEASE TABLETS, USP
2.5 MG, 5 MG AND 10 MG
R 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, 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: calcium silicate, castor oil
polyethoxylated 40,
hydroxypropyl cellulose, hypromellose, lactose monohydrate,
microcrystalline cellulose,
propyl gallate, sodium stearyl fumarate, titanium dioxide, and
triacetin. In addition, the
2.5 mg tablet strength contains FD&C Blue 2/indigo carmine aluminum
lake and iron
oxide yellow and the 5 mg and 10 mg strengths contain iron oxide red.
_ Felodipine extended-release tablets, USP complies with USP
Dissolution Test I and Test_
_II._
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
X
18
19
2
4
++
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 card