PENTOXIFYLLINE tablet, film coated, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Nome Internazionale):

PENTOXIFYLLINE

Composizione:

PENTOXIFYLLINE 400 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Pentoxifylline extended-release tablets, USP 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.

Dettagli prodotto:

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 0615-4523-39 blisterpacks of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505  U.S.A. REVISED APRIL 2015 PENX:R9

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PENTOXIFYLLINE- PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400MG RX ONLY
DESCRIPTION:
Each extended-release tablet, for oral administration, contains 400 mg
of pentoxifylline, USP 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, hydroxyethyl cellulose, hypromellose,
magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, titanium dioxide and triacetin
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 structural formula is:
C
H N O M.W. 278.31
_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 alm