NIFEDIPINE- nifedipine capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

10 mg — Each yellow, opaque, capsule-shaped soft gels imprinted with and 497 with black ink contains 10 mg of nifedipine USP. Capsules are supplied in unit dose packages of 100 (10 x 10) NDC 68084-022-01. 20 mg — Each reddish-brown, opaque, capsule-shaped soft gels imprinted with and 530 with black ink contains 20 mg of nifedipine USP. Capsules are supplied in unit dose packages of 20 (5 x 4) NDC 68084-923-32. Storage : Store at 15°-25°C (59°-77°F). PREVENT FREEZING, CAPSULES ARE LIQUID FILLED. PROTECT CAPSULES FROM LIGHT AT ALL TIMES. PROTECT CAPSULES FROM MOISTURE AND HUMIDITY. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Actavis Pharma, Inc. as follows: (10 mg / 100 UD) NDC 68084-022-01 packaged from NDC 0228-2497 (20 mg / 20 UD) NDC 68084-923-32 packaged from NDC 0228-2530 Distributed by: American Health Packaging Columbus, OH 43217 8202201/1016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE CAPSULE, LIQUID FILLED
AMERICAN HEALTH PACKAGING
REFERENCE LABEL SET ID: EEEF0CDB-7B0B-49E0-A1ED-78311E9F531B
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NIFEDIPINE CAPSULES, USP
8202201/1016
RX ONLY
DESCRIPTION
Nifedipine, USP 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
0
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, USP for oral administration
contain the following inactive
ingredients: glycerin, peppermint oil, and polyethylene glycol. The 10
mg capsule shell and imprinting
ink contains ammonium hydroxide, gelatin, glycerin, iron oxide black,
iron oxide yellow, polyethylene
glycol, polyvinyl acetate phthalate, propylene glycol, and titanium
dioxide. The 20 mg capsule shell and
imprinting ink contains ammonium hydroxide, FD&C red #40, FD&C yellow
#6 (sunset yellow), gelatin,
glycerin, iron oxide black, iron oxide brown, iron oxide red,
polyethylene glycol, polyvinyl acetate
phthalate, propylene glycol, and titanium dioxide.
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
b