NIFEDIPINE- nifedipine tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

NuCare Pharmaceuticals, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

Nifedipine Extended-Release Tablets, USP are supplied as 60 mg round film-coated tablets as follows: 60 mg unscored, round, film-coated tablets, engraved with "B" on one side and "60" on the other side. Bottles of 30 NDC 68071-3315-3 Bottles of 60 NDC 68071-3315-6 The tablets should be protected from light and moisture and stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

授权状态:

Abbreviated New Drug Application

产品特点

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
NUCARE PHARMACEUTICALS, INC.
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NIFEDIPINE
EXTENDED-RELEASE TABLETS, USP
60 MG
RX ONLY
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. 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 60 mg of nifedipine for once-
a-day oral administration.
In addition, each tablet contains the following inactive ingredients:
ethylcellulose, ferric oxide yellow,
hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium
stearate, microcrystalline
cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and
methyl methacrylate), polyethylene
glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium
dioxide.
Nifedipine extended-release tablets meet USP Dissolution Test 4.
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.
17
18
2
6
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 cause of hypertension, results from
an increase in active tension i