PENTOXIFYLLINE tablet extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Pentoxifylline (UNII: SD6QCT3TSU) (Pentoxifylline - UNII:SD6QCT3TSU)

Предлага се от:

AvKARE, Inc.

INN (Международно Name):

Pentoxifylline

Композиция:

Pentoxifylline 400 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

PENTOXIFYLLINE - PENTOXIFYLLINE TABLET, EXTENDED RELEASE
AVKARE, INC.
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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 are reached within 1
hour.