FELODIPINE tablet, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Torrent Pharmaceuticals Limited

INN (Nama Antarabangsa):

FELODIPINE

Komposisi:

FELODIPINE 2.5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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. They are available as follows: Bottles of 30                           NDC 13668-132-30 Bottles of 90                           NDC 13668-132-90 Bottles of 100                         NDC 13668-132-01 Bottles of 500                         NDC 13668-132-05 Bottles of 1000                       NDC 13668-132-10 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. They are available as follows: Bottles of 30                           NDC 13668-133-30 Bottles of 90                           NDC 13668-133-90 Bottles of 100                         NDC 13668-133-01 Bottles of 500                         NDC 13668-133-05 Bottles of 1000                       NDC 13668-133-10 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. They are available as follows: Bottles of 30                           NDC 13668-134-30 Bottles of 90                           NDC 13668-134-90 Bottles of 100                         NDC 13668-134-01 Bottles of 500                         NDC 13668-134-05 Bottles of 1000                       NDC 13668-134-10 Store  at  20° to 25°C  (68° to 77°F) , excursions  permitted  to  15° to 30°C  (59° to 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., India Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. 8088350                                                                                     Revised July 2022

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

FELODIPINE- FELODIPINE TABLET, EXTENDED RELEASE
TORRENT PHARMACEUTICALS LIMITED
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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
MECHANISMOFACTION
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.
18
19
2
4
++
_Invitro_ 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 _invitro_, but such effects have not been seen
in intact animals.
T