NIFEDIPINE- nifedipine tablet, film coated, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Preferred Pharmaceuticals Inc.

INN（国际名称）:

NIFEDIPINE

组成:

NIFEDIPINE 90 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Nifedipine Extended-release Tablet 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 Extended-release Tablet 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 in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers. Nifedipine Extended-release Tablet is indicated for the management of chronic st

產品總結:

Nifedipine Extended-release Tablets 90 mg are round, biconvex, pink coated tablets imprinted with "KU 262 in black ink. They are supplied as follows:  Bottles of 30 Tablets  NDC 68788-6856-3  Bottles of 60 Tablets  NDC 68788-6856-6  Bottles of 90 Tablets  NDC 68788-6856-9  Bottles of 100 Tablets  NDC 68788-6856-1 Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Protect from moisture, humidity, and light. For Medical Information Contact:  Medical Affairs Department Phone: [phone] Distributed by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc. Seymour, IN 47274 Made in the USA CIA70797J Rev. 01/16 Repackaged By: Preferred Pharmaceuticals Inc.

授权状态:

Abbreviated New Drug Application

产品特点

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
NIFEDIPINE _EXTENDED-RELEASE TABLETS, USP_
_ FOR ORAL USE_
_RX ONLY_
CIA70797J
Rev. 01/16
DESCRIPTION
Nifedipine is a drug belonging to a class of pharmacological agents
known as 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 346.33. Nifedipine Extended-release Tablet is
formulated as a once-a-day
extended-release tablet for oral administration designed to deliver
30, 60, or 90 mg of nifedipine.
Inert ingredients in the formulations are: black iron oxide; cellulose
acetate; colloidal silicon dioxide;
hypromellose; lactose monohydrate; magnesium stearate;
microcrystalline cellulose; polyethylene
glycol; polyethylene oxide; polysorbate; povidone; propylene glycol;
red ferric oxide; sodium
chloride; titanium dioxide; triacetin.
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine Extended-release Tablet is similar in appearance to a
conventional tablet. It consists,
however, of a semipermeable membrane surrounding an osmotically active
drug core. As water from
the gastrointestinal tract enters the tablet, pressure increases in
the core of the tablet, releasing drug
through the precision laser-drilled tablet orifice in the one side of
the tablet.
Nifedipine Extended-release Tablet is designed to provide nifedipine
at an approximately constant rate
over 24 hours. This controlled rate of drug delivery into the
gastrointestinal lumen is independent of pH
or gastrointestinal motility.
Nifedipine Extended-release Tablet depends for its action on the
existence of an osmotic gradient
between the contents of the tablet core and fluid in the
gastrointestinal tract. Drug delivery is essentially
constant as long as the osmotic gradient r