NIFEDIPINE tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Alvogen Inc.

INN (International Name):

NIFEDIPINE

Sammensetning:

NIFEDIPINE 30 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Nifedipine Extended-Release Tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See PRECAUTIONS, Drug Interactions .)  Nifedipine must not be used in cases of cardiogenic shock. Nifedipine is contraindicated in patients with a known hypersensitivity to any component of the tablet.

Produkt oppsummering:

Nifedipine Extended-Release Tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows: 30 mg Pink 30 on one side and ADALAT CC on the other side 60 mg Salmon 60 on one side and ADALAT CC on the other side 90 mg Dark Red 90 on one side and ADALAT CC on the other side Nifedipine Extended-Release Tablets are supplied in: Bottles of 100 30 mg 47781-368-01 60 mg 47781-369-01 90 mg 47781-370-01 The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers (USP). Manufactured for: Alvogen, Inc. Pine Brook, NJ 07058 USA Rx Only PI368-00 Rev. 04/2016 P

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
ALVOGEN INC.
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NIFEDIPINE
EXTENDED-RELEASE TABLETS
FOR ORAL USE
DESCRIPTION
Nifedipine Extended-Release Tablets are an extended-release tablet
dosage form of the calcium
channel blocker nifedipine. 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 Extended-Release Tablets
consist of an external coat and an
internal core. Both contain nifedipine, the coat as a slow release
formulation and the core as a fast
release formulation. Nifedipine Extended-Release Tablets contain
either: 30, 60, or 90 mg of
nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: hydroxypropylcellulose,
lactose, corn starch, crospovidone,
microcrystalline cellulose, silicon dioxide, and magnesium stearate.
The inert ingredients in the film
coating for Nifedipine Extended-Release Tablets 30 mg and 60 mg are:
hypromellose, polyethylene
glycol, ferric oxide, and titanium dioxide. The inert ingredients in
the film coating for Nifedipine
Extended-Release Tablets 90 mg are: hypromellose, polyethylene glycol
and ferric oxide.
CLINICAL PHARMACOLOGY
Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or
calcium ion antagonist) which
inhibits the transmembrane influx of calcium ions into vascular smooth
muscle and cardiac muscle. The
contractile processes of vascular smooth muscle and cardiac 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 vascular
smooth muscle and cardiac muscle
without altering serum calcium concentrations.
MECHANISM OF ACTION
The mechanism by which nifedipine reduces arterial blood pressure
involves peripheral arterial
vasodilat