FELODIPINE tablet, film coated, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Bryant Ranch Prepack

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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, f

Rezumat produs:

NDC: 71335-1318-1: 30 Tablets in a BOTTLE

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FELODIPINE- FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
FELODIPINE EXTENDED-RELEASE TABLETS, USP
RX 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
dichloromethane and ethanol.
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. In addition to the active ingredient felodipine, the
tablets contain the
following inactive ingredients: colloidal silicon dioxide, heavy
aluminium silicate,
hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose
monohydrate,
microcrystalline cellulose, polyethylene glycol, polyoxyl 40
hydrogenated castor oil,
propyl gallate, sodium stearyl fumarate, titanium dioxide. In addition
the 2.5 mg 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 and iron oxide yellow.
CLINICAL PHARMACOLOGY
18
19
2
4
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