NIFEDIPINE tablet, film coated, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

NIFEDIPINE

Sammensætning:

NIFEDIPINE 30 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 oversigt:

Nifedipine Extended-Release Tablets, USP are available containing 30 mg, 60 mg or 90 mg of nifedipine, USP. The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and NE over 30 on the other side. They are available as follows: NDC 0378-0353-77 bottles of 90 tablets NDC 0378-0353-01 bottles of 100 tablets NDC 0378-0353-10 bottles of 1000 tablets The 60 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and NE over 60 on the other side. They are available as follows: NDC 0378-0360-77 bottles of 90 tablets NDC 0378-0360-01 bottles of 100 tablets NDC 0378-0360-10 bottles of 1000 tablets The 90 mg tablets are pink, film-coated, round, unscored tablets debossed with M on one side of the tablet and NE over 90 on the other side. They are available as follows: NDC 0378-0390-77 bottles of 90 tablets NDC 0378-0390-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brands listed are trademarks of their respective owners. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 7/2018 NIFECC:R4

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE- NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Nifedipine is an extended-release tablet dosage form of the calcium
channel blocker nifedipine.
Nifedipine is Dimethyl
1,4-dihydro-2,6-dimethyl-4-(_o_-nitrophenyl)-3,5-pyridinedicarboxylate,
C
H N O , and has the structural formula:
Nifedipine, USP is a yellow powder, practically insoluble in water but
soluble in ethanol. It has a
molecular weight of 346.33. 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, USP contain
either 30, 60 or 90 mg of
nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: colloidal silicon dioxide,
hydroxypropyl cellulose,
hypromellose, lactose monohydrate, magnesium stearate, polydextrose,
polyethylene glycol, titanium
dioxide and triacetin. The 60 mg tablets also contain FD&C Yellow No.
6 Aluminum Lake and the 90
mg tablets also contain D&C Red No. 27, FD&C Blue No. 2 and FD&C Red
No. 40.
_Meets USP Dissolution Test 9._
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
vasodilatation and, consequently, a reduction in peripheral vascular
resistance. The increased peripheral
vascular resistance, an underlying cause of hypertension, results from