PENTOXIFYLLINE tablet film coated extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

PENTOXIFYLLINE

Composition:

PENTOXIFYLLINE 400 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE
CARDINAL HEALTH
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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 undergoes
a first-pass effect a