NIFEDIPINE capsule, liquid filled

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

AvPAK

INN (International Name):

NIFEDIPINE

Sammensætning:

NIFEDIPINE 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

10 mg — Each yellow, opaque, capsule-shaped soft gels imprinted with and 497 with black ink contains 10 mg of nifedipine USP. NDC 50268-600-15    10 capsules per card, 5 card per carton 20 mg — Each reddish-brown, opaque, capsule-shaped soft gels imprinted with and 530 with black ink contains 20 mg of nifedipine USP. NDC 50268-601-15    10 capsules per card, 5 card per carton Dispensed in blister punch material. For Institutional Use Only. Storage : Store at 15° to 25°C (59° to 77°F). PREVENT FREEZING, CAPSULES ARE LIQUID FILLED. PROTECT CAPSULES FROM LIGHT AT ALL TIMES. PROTECT CAPSULES FROM MOISTURE AND HUMIDITY. Manufactured for: AvKARE, Inc. Pulaski, TN  38478 Mfg. Rev. 06/15 AV 07/15 (P) AvPAK

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE- NIFEDIPINE CAPSULE, LIQUID FILLED
AVPAK
----------
NIFEDIPINE CAPSULES, USP
40-9173
Revised — June 2015
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
17
18
2
6,
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 follo