NIFEDIPINE tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

NIFEDIPINE (UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)

Διαθέσιμο από:

Ingenus Pharmaceuticals, LLC

INN (Διεθνής Όνομα):

NIFEDIPINE

Σύνθεση:

NIFEDIPINE 30 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (SeePRECAUTIONS, Drug Interactions. ) Nifedipine must not be used in cases of cardiogenic shock. Nifedipine extended-release tablets are contraindicated in patients with a known hypersensitivity to any component of the tablet.

Περίληψη προϊόντος:

Nifedipine extended-release tablets, USP are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows: Nifedipine extended-release tablets, USP are supplied in the following bottle configurations: The tablets should be protected from light and moisture and stored at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
INGENUS PHARMACEUTICALS, LLC
----------
NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 30MG, 60MG AND 90MG
DESCRIPTION
Nifedipine extended-release tablets, USP are an extended release
tablet dosage form of
the calcium channel blocker nifedipine. Nifedipine is
3,5-pyridinedicarboxylic acid, 1,4-
dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C
H
N O , and has the
structural formula:
Product meets USP dissolution test 10.
Nifedipine is a yellow crystalline substance, practically insoluble in
water but soluble in
ethanol. It has a molecular weight of 346.3. Nifedipine extended
release tablets contain
either: 30, 60, or 90 mg of nifedipine for once-a-day oral
administration.
Inert ingredients in the 30mg nifedipine extended-release tablet
formulation are lactose
monohydrate, microcrystalline cellulose, hypromellose, magnesium
stearate, polyvinyl
alcohol, talc, titanium dioxide, macrogol/polyethylene glycol 3350,
lecithin (soy), iron
oxide yellow and iron oxide black.
Inert ingredients in the 60mg nifedipine extended-release tablet
formulation are lactose
monohydrate, microcrystalline cellulose, hypromellose, magnesium
stearate, polyvinyl
alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350,
lecithin (soy), iron
oxide red, iron oxide black and iron oxide yellow.
Inert ingredients in the 90mg nifedipine extended-release tablet
formulation are: lactose
monohydrate, microcrystalline cellulose, hypromellose, magnesium
stearate, polyvinyl
17
18
2
6
alcohol, iron oxide red, talc, macrogol/polyethylene glycol 3350, iron
oxide yellow,
titanium dioxide, lecithin (soy) and iron oxide black.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist)
which inhibits the transmembrane influx of calcium ions into vascular
smooth muscle
and cardiac muscle. The contractile processes of vascular smooth
muscle and cardiac
muscle are dependent upon the movement of extracellular calcium ions
into these cells
through spe