PENTOXIFYLLINE tablet, extended release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

ANI Pharmaceuticals, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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.

Огляд продуктів:

Pentoxifylline Extended-Release Tablets USP, 400 mg are available for oral administration as yellow, oblong, film-coated tablets, embossed with “N668” on one side and plain on the other. They are supplied in bottles of 100 (NDC 70954-668-10) and bottles of 500 (NDC 70954-668-20). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Rx only Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 04/2023 LB4581-00

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, EXTENDED RELEASE
ANI PHARMACEUTICALS, INC.
----------
PENTOXIFYLLINE EXTENDED-RELEASE TABLETS USP
RX ONLY
DESCRIPTION
Pentoxifylline Extended-Release Tablets USP for oral administration
contain 400 mg of
the active drug and the following inactive ingredients: hypromellose,
povidone, talc,
magnesium stearate, maltodextrin, polyethylene glycol, titanium
dioxide, triacetin, D&C
yellow #10 aluminum lake and FD&C yellow #6 in an extended-release
formulation.
Pentoxifylline is a tri-substituted xanthine derivative designated
chemically as 3,7-
Dihydro-3,7-dimethyl-1-(5-oxohexyl)-1_H_‑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 chemical structure is:
Pentoxifylline Extended-Release Tablets USP comply with USP
dissolution test 7.
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 va