PENTOXIFYLLINE- pentoxifylline tablet, extended release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Preferred Pharmaceuticals, Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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.

Prehľad produktov:

Pentoxifylline extended-release tablets, USP are available for oral administration as 400 mg white, oval, unscored, film coated tablets, imprinted “APO 033” on one side and plain on the other side; supplied in bottle of 30 - 68788-9742-3. Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400mg Manufactured by                Manufactured for Apotex Inc.                          Apotex Corp. Toronto, Ontario                   Weston, Florida Canada M9L 1T9                  33326 Revised: May 2016  Rev. 7 Repackaged By: Preferred Pharmaceuticals Inc.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS, INC.
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PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 MG
RX ONLY
DESCRIPTION
Pentoxifylline extended-release tablets, USP for oral administration
contain 400 mg of the active drug
and the following inactive ingredients: colloidal silicon dioxide,
hydroxypropyl cellulose,
hypromellose, magnesium stearate, polyethylene glycol, and titanium
dioxide in an extended-release
formulation. Pentoxifylline is a tri-substituted xanthine derivative
designated chemically as 3,7-
Dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione 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 molecular formula is C
H N O and its molecular
weight is 278.31.
The chemical structure is:
USP Dissolution Test 9
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 metabo