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:

Oceanside Pharmaceuticals

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 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 Cmax 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 ide

Περίληψη προϊόντος:

Nifedipine Extended-Release Tablets, USP are supplied as 90 mg unscored, round film-coated tablets as follows: 90 mg Yellow 90 mg unscored, round, film-coated tablets, engraved with "B" on one side and "90" on the other side. Nifedipine Extended-Release Tablets, USP are supplied in: 90 mg Bottles of 100 68682-107-10 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. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada © 2019 Bausch Health Companies Inc. or its affiliates 9495504 20002765 Rev. 10/2019

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NIFEDIPINE- NIFEDIPINE TABLET, EXTENDED RELEASE
OCEANSIDE PHARMACEUTICALS
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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
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 o