NIFEDIPINE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Golden State Medical Supply, Inc.

INN (Διεθνής Όνομα):

NIFEDIPINE

Σύνθεση:

NIFEDIPINE 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Nifedipine soft gelatin capsules are reddish-brown soft gelatin capsules, imprinted IMI 10 with white ink and are supplied in: Bottles of 100: 10 mg (NDC 60429-163-01) The capsules should be protected from light and moisture and stored at controlled room temperature 20° to25°C (68°to 77°F) in the manufacturer’s original container. [See USP Controlled Room Temperature] Rx only PI4400000202 March 2018 Manufactured by: International Vitamin Corporation Irvington, NJ 07111 Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NIFEDIPINE- NIFEDIPINE CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
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NIFEDIPINE CAPSULES
DESCRIPTION
Nifedipine is an antianginal drug belonging to a class of
pharmacological agents, the calcium channel
blockers. 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:
Nifedipine 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 nifedipine.
Inert ingredients in the formulation are: FD&C blue number 1 lake,
gelatin, glycerin, isobutyl alcohol,
menthol, polyethylene glycol, polyvinylpyrrolidone, red iron oxide,
shellac, sorbitol, sorbitans, 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 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 two mechanisms:
_1) RELAXATION AND PREVENTION OF CORONARY ARTERY SPASM_
Nifedipine dilates the main coronary arteries and coronary arterioles,
both in normal and ischemic
regions, and is a potent inhibitor of coronary artery spasm, whether
spontaneous or ergonovine-
induced. This property increases myocardial oxygen delivery in
patients with coronary artery spasm,
and is responsible for the effectiveness of nifedipine in vasospastic
(Prinzmetal’s or variant) angina.
Whether this effec