FELODIPINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FELODIPINE (UNII: OL961R6O2C) (FELODIPINE - UNII:OL961R6O2C)

Available from:

Carlsbad Technology, Inc.

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 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 Nat

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 tablets are white film-coated, round, unscored tablets debossed with “YSP 211 ”on one side of the tablets. They are available as follows: NDC 61442-431-01 bottles of 100 tablets NDC 61442-431-05 bottles of 500 tablets The 5 mg tablets are orange film-coated, round, unscored tablets debossed with “YSP 210” on one side of the tablets. They are available as follows: NDC 61442-432-01 bottles of 100 tablets NDC 61442-432-05 bottles of 500 tablets The 10 mg tablets are red film-coated, round, unscored tablets debossed with “YSP 051” on one side of the tablets. They are available as follows: NDC 61442-433-01 bottles of 100 tablets NDC 61442-433-05 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. Manufactured by: Yung Shin Pharmaceutical Ind. Co., Ltd. Tachia, Taichung 43769, TAIWAN Distributed by: Carlsbad Technology, Inc. 5922 Farnsworth Court, Carlsbad, CA 92008, USA Revised: 03/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FELODIPINE- FELODIPINE TABLET, FILM COATED
CARLSBAD TECHNOLOGY, INC.
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FELODIPINE 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 C18H19Cl12NO4 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: lactose
monohydrate,
hydroxypropyl cellulose, silicon dioxide colloidal, hypromellose,
magnesium
stearate, calcium phosphate dibasic, butylated hydroxyanisole,
polyethylene
glycol, titanuium dioxide. In addition, the 5 mg and the 10 mg tablet
strength
contain FD&C Red No. 40 powder, 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 intact animals.
The effect of felodipine on blood pressure is principally a
consequence of a
dose related decrease of peripheral vascular resistance i