NIFEDIPINE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Cardinal Health

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 wh

Produkt oversigt:

Nifedipine soft gelatin capsules are reddish-brown soft gelatin capsules, imprinted IMI 10 with white ink and are supplied: Overbagged with 10 capsules per bag (NDC 55154-8199-0) The capsules should be protected from light and moisture and stored at controlled room temperature 20° to25°C (68°to 77°F). [See USP Controlled Room Temperature] Rx only FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE- NIFEDIPINE CAPSULE
CARDINAL HEALTH
----------
NIFEDIPINE CAPSULES
8442501/1118
RX ONLY
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:
17
18
2
6
_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.
Wheth