FELODIPINE tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 class

Produkt oppsummering:

NDC: 63629-2322-1: 500 Tablets in a BOTTLE

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FELODIPINE- FELODIPINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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FELODIPINE EXTENDED-RELEASE TABLETS, USP
2.5MG, 5MG AND 10MG
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 empirical
formula is C
H
Cl
NO
and its structural formula is:
Felodipine 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, USP provide extended release of
felodipine. They
are available as tablets containing 2.5 mg, 5 mg, or 10 mg of
felodipine for oral
administration.
Inactive ingredients for core tablets are: anhydrous lactose,
butylated hydroxyanisole,
butylated hydroxytoluene, colloidal silicon dioxide, hypromellose,
polyoxyl 40
hydrogenated castor oil, microcrystalline cellulose, povidone K30 and
sodium stearyl
fumarate.
Film coating materials of 2.5mg: ferrosoferric oxide, hypromellose,
iron oxide red, iron
oxide yellow, maltodextrin, medium chain triglycerides, polydextrose,
talc and titanium
dioxide.
Film coating materials of 5mg: ferrosoferric oxide, hypromellose, iron
oxide red, iron
oxide yellow, maltodextrin, medium chain triglycerides, polydextrose,
talc and titanium
dioxide.
Film coating materials of 10mg: ferrosoferric oxide, hypromellose,
iron oxide red, iron
oxide yellow, maltodextrin, medium chain triglycerides, polydextrose,
talc and titanium
dioxide.
18
19
2
4
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
potassiu