NIFEDIPINE- nifedipine tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nifedipine extended-release tablets 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 extended-release tablets 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 tablets are indicated for the management of chron

Product summary:

Nifedipine extended-release tablets USP are supplied as 60 mg round, biconvex, rose-pink, film-coated tablets with “T010” in black ink on one side and plain on the other side: Bottles of 30: (NDC 68788-6773-3) Bottles of 60: (NDC 68788-6773-6) Bottles of 90: (NDC 68788-6773-6) Bottles of 100: (NDC 68788-6773-1) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Protect from moisture and humidity. Manufactured for: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 Manufactured by: China Chemical & Pharmaceutical Co., Ltd. Tainan City, 72042, Taiwan OS011 01/2017 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS, INC.
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NIFEDIPINE EXTENDED-RELEASE TABLETS, USP
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 346.3. Nifedipine GITS (Gastrointestinal
Therapeutic System) tablet is
17
18
2
6
formulated as a once-a-day controlled-release tablet for oral
administration designed to deliver 30, 60,
or 90 mg of nifedipine.
Inert ingredients in the formulations are: cellulose acetate; ferric
oxide; hypromellose; magnesium
stearate; polyethylene glycol; polyethylene oxide; potassium chloride;
povidone; sodium chloride;
titanium dioxide; propylene glycol and black iron oxide.
The USP Dissolution Test is pending.
SYSTEM COMPONENTS AND PERFORMANCE
Nifedipine extended-release tablets are similar in appearance to a
conventional tablet. It consists,
however, of a semipermeable membrane surrounding an osmotically active
drug core. The core itself is
divided into two layers: an “active” layer containing the drug,
and a “push” layer containing
pharmacologically inert (but osmotically active) components. As water
from the gastrointestinal tract
enters the tablet, pressure increases in the osmotic layer and
“pushes” against the drug layer, releasing
drug through the precision laser-drilled tablet orifice in the active
layer.
Nifedipine extended-release tablets are 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 tablets
depend for its action on the existence of
an osmotic gradient between the contents of the bi-layer core and
fluid