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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

NIFEDIPINE

Composition:

NIFEDIPINE 90 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 extended-release tablets are contraindicated in patients with a known hypersensitivity to any component of the tablet. The safety and effectiveness of nifedipine in pediatric patients have not been established. Although small pharmacokinetic studies have identified an increased half-life and increased C max and AUC (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism ), clinical studies of nifedipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not id

Product summary:

Nifedipine Extended-Release Tablets, USP are supplied as 90 mg round film-coated tablets as follows Round Yellow Tablets Engraved: B on one side 90 on the other side The tablets should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled RoomTemperature]. Dispense in tight, light-resistant containers. Manufactured by: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 1Z7 Canada Distributed by: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA 9495502 20001683 Rev. 06/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
90 MG
RX ONLY
FOR ORAL USE
DESCRIPTION
Nifedipine extended-release tablets are an extended-release tablet
dosage form of the calcium channel
blocker nifedipine. The product is provided as a general matrix tablet
with a polymer coating.
Nifedipine is 3,5-pyridinedicarboxylic acid,
1,4-dihydro-2,6-dimethyl-4-(2 _-_nitrophenyl)-, dimethyl
ester. The molecular formula is 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
contain 90 mg of nifedipine for once-
a-day oral administration.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose,
magnesium stearate, microcrystalline
cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate,
titanium dioxide, and triacetin.
Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
Nifedipine extended-release tablets meet USP Dissolution Test 7.
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
17
18
2
6
without altering serum calcium concentrations.
MECHANISM OF ACTION
The mechanism by which nifedipine reduces arterial blood pressure
involves peripheral arterial
vasodilatation and, consequently, a reduction in peripheral vascular
resistance. The increased peripheral
vascular resistance, an underlying c