FELODIPINE- felodipine tablet, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Medsource Pharmaceuticals

INN (Tarptautinis Pavadinimas):

FELODIPINE

Sudėtis:

FELODIPINE 5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Felodipine extended-release tablets are indicated for the treatment of hypertension. Felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents. Felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product. Safety and effectiveness in pediatric patients have not been established. Clinical studies of felodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Pharmacokinetics, however, indicate that the availability of felodipine is increased in older patients (see CLINICAL PHARMACOLOGY: Geriatric Use). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of conco

Produkto santrauka:

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 green-colored, round-shaped, biconvex film-coated tablets debossed with "32" on one side and "2.5" on other side. The 5 mg tablet is a pink-colored, round-shaped, biconvex film-coated tablets debossed with "33" on one side and "5" on other side. The 10 mg tablet is a reddish brown-colored, round-shaped, biconvex film-coated tablets debossed with "34" on one side and "10" on other side. Store at 20°-25°C (68°-77°F) , excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721 Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. 8045811 Revised February 2014

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FELODIPINE- FELODIPINE TABLET, EXTENDED RELEASE
MEDSOURCE PHARMACEUTICALS
----------
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 acetone and in methanol;
very slightly soluble in heptane.
Felodipine is a racemic mixture.
Felodipine extended-release tablets 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: colloidal silicon dioxide, hydroxy propyl cellulose,
hypromellose, lactose anhydrous, magnesium
oxide, microcrystalline cellulose, polyoxyl 40 hydrogenated castor
oil, propyl gallate, propylene
glycol, sodium stearyl fumarate, talc, titanium dioxide and additional
agents listed below:
2.5 mg tablets: Ferric oxide yellow and lake of indigo carmine
5 and 10 mg tablets: Ferric oxide red and ferric oxide yellow
_MeetsUSPDissolutionTest3._
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 o