NIFEDIPINE EXTENDED RELEASE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

American Health Packaging

INN (International Name):

NIFEDIPINE

Sammensætning:

NIFEDIPINE 30 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE EXTENDED RELEASE- NIFEDIPINE TABLET, EXTENDED RELEASE
AMERICAN HEALTH PACKAGING
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NIFEDIPINE EXTENDED-RELEASE TABLETS, USP
30 MG AND 60 MG
8297932/1015OS
RX ONLY
FOR ORAL USE
DESCRIPTION
Nifedipine Extended-Release Tablets, USP 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, USP 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 either 30 or 60 mg of
nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: colloidal silicon dioxide,
hypromellose, lactose monohydrate,
magnesium stearate. The inert ingredients in the film coating are:
hypromellose, polydextrose,
polyethylene glycol 8000, triacetin, yellow iron oxide and titanium
dioxide.
Product meets USP dissolution test #6.
CLINICAL PHARMACOLOGY
Nifedipine, USP 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
17
18
2
6
vascular resistance, an underlying cause of hypertension, results from
an increase in active tension in
the vascular smooth muscle. Studies have demonstrated that the
increase in active tensio