NIFEDIPINE tablet, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

State of Florida DOH Central Pharmacy

INN (International Name):

NIFEDIPINE

Sammensætning:

NIFEDIPINE 30 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Nifedipine extended-release tablets is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Known hypersensitivity to nifedipine.

Produkt oversigt:

Nifedipine extended-release tablets are supplied as 30 mg and 60 mg round, biconvex, film-coated tablets which are 11 mm in diameter and 6 mm in height. They are supplied by State of Florida DOH Central Pharmacy as follows: The tablets should be protected from light and moisture and stored at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light--resistant containers. Manufactured by: Eurand, Inc. Vandalia, OH 45377 Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States RX Only

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NIFEDIPINE - NIFEDIPINE TABLET, EXTENDED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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NIFEDIPINE EXTENDED-RELEASE TABLETS 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, 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 either 30 or 60 mg of
nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: colloidial silicon dioxide,
hypromellose, lactose monohydrate,
magnesium stearate. The inert ingredients in the film coating are:
hypromellose, polydextrose,
polyethylene glycol, triacetin, yellow iron oxide, and titanium
dioxide.
Dissolution test is pending.
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 that is 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 tension reflects an increase in cytosolic free calcium.
Nifedipine is a peripheral ar