NIFEDIPINE capsule, liquid filled

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

STAT RX USA LLC

INN (Tên quốc tế):

NIFEDIPINE

Thành phần:

NIFEDIPINE 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. ll. Chronic Stable Angina (Classical Effort-Associated Angina) : Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm i

Tóm tắt sản phẩm:

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 bottles of 100 (NDC 0228-2497-10). 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 bottles of 100 (NDC 0228-2530-10). 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. REPLACE CAP TIGHTLY AFTER EACH OPENING. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Encapsulated by: Cardinal Health 409, Inc. St. Petersburg, FL 33716 40-8986 Revised — February 2006

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NIFEDIPINE - NIFEDIPINE CAPSULE, LIQUID FILLED
STAT RX USA LLC
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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 0 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 or 20 mg nifedipine.
INACTIVE INGREDIENTS: Nifedipine capsules for oral administration
contain the following inactive
ingredients: glycerin, peppermint oil, and polyethylene glycol. The 10
mg capsule shell contains
gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow,
propylene glycol, and titanium
dioxide. The 20 mg capsule shell contains FD and C red #40, FD and C
yellow #6 (sunset yellow),
gelatin, glycerin, hypromellose, iron oxide black, iron oxide brown,
iron oxide red, 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 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 ar