PENTOXIFYLLINE tablet, extended release

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Bryant Ranch Prepack

INN (Међународно име):

PENTOXIFYLLINE

Састав:

PENTOXIFYLLINE 400 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

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 NDC: 63629-2910-1: 30 Tablets in a BOTTLE NDC: 63629-2910-2: 60 Tablets in a BOTTLE NDC: 63629-2910-3: 90 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
----------
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
13
18
4
3
After oral administration in aqueous solution pentoxifylline is almost
completely
absorbed. It undergoes a first-pass effect and the various metab