NIFEDIPINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Leading Pharma, LLC

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nifedipine capsules, USP (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 capsules, USP 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. Nifedipine capsules, USP is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate

Product summary:

Nifedipine capsules USP, 20 mg: Each opaque red soft gelatin capsule, imprinted N20, contains nifedipine USP, packaged in bottles of 100: 20 mg (NDC 69315-212-01). Store at 59° to 77°F (15° to 25°C) [See USP Controlled Room Temperature]. DO NOT PERMIT TO FREEZE. Dispense in a tight, light-resistant container as defined in the USP. PROTECT FROM MOISTURE AND HUMIDITY. Manufactured by: Catalent Pharma Solutions, LLC 2725 Scherer Drive North, St Petersburg, Florida (FL) 33716-1016, United States (USA). Distributed by: Leading Pharma, LLC Fairfield, NJ 07004. Rev. 01 12/19

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE CAPSULE
LEADING PHARMA, LLC
----------
NIFEDIPINE CAPSULES, USP
FOR ORAL USE
DESCRIPTION
Nifedipine capsules, USP (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, USP
are formulated as
soft gelatin capsules for oral administration each containing 20 mg
nifedipine.
Inert ingredients in the formulations are: glycerin, peppermint oil,
polyethylene glycol,
saccharin sodium, gelatin, FD&C Yellow #6, FD&C Red #40, titanium
dioxide, ink white
opacode (WB) NSP- 78-18022 (comprises of: polyethylene
glycol/macrogol, polyvinyl
acetate phthalate, titanium dioxide, propylene glycol) 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 coronar