NIFEDIPINE- nifedipine tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Nifedipine Extended-release Tablets 30 mg are round, biconvex, pink coated tablets imprinted with "KU 260" in black ink. They are supplied as follows: Nifedipine Extended-release Tablets 60 mg are round, biconvex, pink coated tablets imprinted with "KU 261" in black ink. They are supplied as follows: 55700-397-30 55700-397-60 55700-397-90 Nifedipine Extended-release Tablets 90 mg are round, biconvex, pink coated tablets imprinted with "KU 262 in black ink. They are supplied as follows: 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
_FOR ORAL USE_
RX ONLY
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 remains constant, and then
gradually falls to zero.