PENTOXIFYLLINE- 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:

Mylan Institutional Inc.

INN (International Name):

PENTOXIFYLLINE

Composition:

PENTOXIFYLLINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 extended-release tablets 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.

Product summary:

Pentoxifylline Extended-Release Tablets, USP are available containing 400 mg of pentoxifylline, USP. The 400 mg tablet is a lavender, film-coated, modified capsule-shaped, unscored tablet debossed with MYLAN on one side of the tablet and 357 on the other side. It is available as follows: NDC 51079-889-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-6727 R13 6/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN INSTITUTIONAL INC.
----------
DESCRIPTION
Pentoxifylline extended-release tablets, USP for oral administration
contain 400 mg of the active drug
and the following inactive ingredients: D&C Red No. 30 Aluminum Lake,
FD&C Blue No. 2 Aluminum
Lake, FD&C Yellow No. 6 Aluminum Lake, hydroxyethylcellulose,
hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, titanium dioxide and triacetin
in an extended-release formulation. Pentoxifylline extended-release
tablets are 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 CAS Registry Number is
6493-05-6.
The chemical structure is:
_Meets USP Dissolution 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