PENTOXIFYLLINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

PENTOXIFYLLINE

Composition:

PENTOXIFYLLINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentoxifylline extended-release tablet is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablet 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 tablet 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.

Product summary:

Pentoxifylline extended-release tablet is available for oral administration as 400 mg white, oblong, compressed tablets, engraved with "BVF" on one side and "0117" on the other; tablets are unscored; supplied in bottles of 100 (NDC 68682-101-10) and 500 (NDC 68682-101-50). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers with safety closures.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, 400 MG
RX ONLY
DESCRIPTION
Pentoxifylline extended-release tablets for oral administration,
contains 400 mg of the active drug and
the following inactive ingredients: hydroxyethyl cellulose, isopropyl
alcohol, magnesium stearate,
povidone, and talc 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 chemical structure is:
Molecular weight: 278.31
Molecular formula: C
H N O
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 and the various metabolites appear in plasma very
soon after dosing. Peak plasma
levels of the parent compound and its metabolites a