PENTOXIFYLLINE tablet, film coated, extended release

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

PENTOXIFYLLINE (UNII: SD6QCT3TSU) (PENTOXIFYLLINE - UNII:SD6QCT3TSU)

Fáanlegur frá:

State of Florida DOH Central Pharmacy

INN (Alþjóðlegt nafn):

PENTOXIFYLLINE

Samsetning:

PENTOXIFYLLINE 400 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease. Pentoxifylline extended-release tablets should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.

Vörulýsing:

Pentoxifylline Extended-release Tablets, USP are available as film coated, lavender, unscored, capsule-shaped tablets, each containing 400 mg of pentoxifylline. The tablet is debossed with MYLAN on one side and 357 on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. This product was manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

PENTOXIFYLLINE - PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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DESCRIPTION
Each extended-release tablet, for oral administration, contains 400 mg
of pentoxifylline and the
following inactive ingredients: D&C Red #30 Aluminum Lake, FD&C Blue
#2 Aluminum Lake, FD&C
Yellow #6 Aluminum Lake, hydroxyethyl cellulose, hypromellose,
magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, titanium dioxide and triacetin
in an extended-release formulation. Pentoxifylline is a
tri-substituted xanthine derivative designated
chemically as 1-(5-oxohexyl)-3,7-dimethylxanthine that, unlike
theophylline, is a hemorrheologic agent,
i.e. an agent that affects blood viscosity. Pentoxifylline is soluble
in water and ethanol, and sparingly
soluble in toluene.
The structural formula is:
C H N O M.W. 278.31
Pentoxifylline Extended-release Tablets, USP meet _USP Drug Release
Test 6_.
CLINICAL PHARMACOLOGY
MODE OF ACTION
Pentoxifylline and its metabolites improve the flow properties of
blood by decreasing its viscosity. In
patients with chronic peripheral arterial disease, this increases
blood flow to the affected
microcirculation and enhances tissue oxygenation. The precise mode of
action of pentoxifylline and the
sequence of events leading to clinical improvement are still to be
defined. Pentoxifylline administration
has been shown to produce dose related hemorrheologic effects,
lowering blood viscosity, and
improving erythrocyte flexibility. Leukocyte properties of
hemorrheologic importance have been
modified in animal and _in vitro_ human studies. Pentoxifylline has
been shown to increase leukocyte
deformability and to inhibit neutrophil adhesion and activation.
Tissue oxygen levels have been shown
to be significantly increased by therapeutic doses of pentoxifylline
in patients with peripheral arterial
disease.
PHARMACOKINETICS AND METABOLISM
After oral administration in aqueous solution pentoxifylline is almost
completely absorbed. It undergoe