NIFEDIPINE tablet, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

INN (Διεθνής Όνομα):

NIFEDIPINE

Σύνθεση:

NIFEDIPINE 90 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. - (Classical Effort-Associated Angina) (Classical Effort-Associated Angina

Περίληψη προϊόντος:

Nifedipine extended-release tablets USP are supplied as 90 mg round, biconvex, rose-pink, film-coated tablets with T009 in black ink on one side and plain on the other side: NDC 68071-4097-3 Bottles of 30 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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
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 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
17
18
2
6
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 in