NIFEDIPINE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

NIFEDIPINE

Sammensætning:

NIFEDIPINE 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

I. Vasospastic Angina Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers. II. Chronic Stable Angina (Classical Effort-Associated Angina) Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain

Produkt oversigt:

Nifedipine Capsules, USP are available as white opaque, oblong soft gelatin capsules containing 10 mg of nifedipine. Each capsule is imprinted with "HP 194" in black ink. They are supplied as follows: Bottles of 100: 10 mg (NDC 23155-194-01) Bottles of 300: 10 mg (NDC 23155-194-13) Nifedipine Capsules, USP are available as peach opaque, oblong soft gelatin capsules containing 20 mg of nifedipine. Each capsule is imprinted with "HP 195" in black ink. They are supplied as follows: Bottles of 100: 20 mg (NDC 23155-195-01) The capsules should be protected from light and moisture and stored at Controlled Room Temperature 68° to 77°F (20° to 25°C); excursions permitted to 15° to 30°C (59° to 86°F), in the manufacturer's original container. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000140US07 Revised: 03/2022

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE- NIFEDIPINE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
RX ONLY
DESCRIPTION
Nifedipine, USP is an antianginal drug belonging to a class of
pharmacological agents, the
calcium channel blockers. Nifedipine is 1, 4-Dihydro-2,
6-dimethyl-4-(2-nitrophenyl)-3, 5-
pyridinecarboxylic acid dimethyl ester, C
H
N O , and has the structural formula:
Nifedipine, USP is a yellow crystalline substance, practically
insoluble in water but soluble
in ethanol. It has a molecular weight of 346.3. Nifedipine capsules
are formulated as soft
gelatin capsules for oral administration, each containing 10 mg or 20
mg nifedipine.
INACTIVE INGREDIENTS: Nifedipine capsules for oral administration
contain the following
inactive ingredients: glycerin, peppermint oil, polyethylene glycol
and saccharin sodium.
The 10 mg capsule shell contains ammonium hydroxide, gelatin,
glycerin, iron oxide
black, light mineral oil, methyl paraben, propylene glycol, propyl
paraben, shellac glaze,
sorbitol, titanium dioxide and water. The 20 mg capsule shell contains
ammonium
hydroxide, FD and C Red No. 40 aluminum lake, FD and C Yellow No. 6
aluminum
lake, gelatin, glycerin, iron oxide black, light mineral oil, methyl
paraben, propylene glycol,
propyl paraben, shellac glaze, sorbitol, titanium dioxide and water.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist)
and inhibits the transmembrane influx of calcium ions into cardiac
muscle and smooth
muscle. The contractile processes of cardiac muscle and vascular
smooth muscle are
dependent upon the movement of extracellular calcium ions into these
cells through
specific ion channels. Nifedipine selectively inhibits calcium ion
influx across the cell
17
18
2
6
membrane of cardiac muscle and vascular smooth muscle without changing
serum
calcium concentrations.
MECHANISM OF ACTION
The precise means by which this inhibition relieves angina has not
been fully determined,
but includes at least the following tw