Pentoxifylline 400 MG Extended Release Oral Tablet

OVERDOSAGE

Overdosage with pentoxifylline has been reported in pediatric patients and adults.

Symptoms appear to be dose related.

A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline tablets noted that symptoms usually occurred 4 to 5 hours after ingestion and lasted about 12 hours.

The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred.

All patients recovered.

In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions.

Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.

DESCRIPTION

Each extended-release tablet, for oral administration, contains 400 mg of pentoxifylline and the following inactive ingredients: D&C Red #30 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #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 13H 18N 4O 3 M.W.

278.31 Pentoxifylline Extended-release Tablets, USP meet USP Drug Release Test 6.

MM1

HOW SUPPLIED

Pentoxifylline Extended-release Tablets, USP are available as film coated, lavender, unscored, capsule-shaped tablets, each containing 400 mg of pentoxifylline.

The tablet is debossed with MYLAN on one side and 357 on the other side.

It is available as follows: NDC 0378-0357-01 bottles of 100 tablets NDC 0378-0357-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F).

[See USP for 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 REVISED NOVEMBER 2005 PENX:R7

INDICATIONS AND USAGE

INDICATIONS & USAGE 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION The usual dosage of pentoxifylline in extended-release tablet form is one tablet (400 mg) three times a day with meals.

While the effect of pentoxifylline may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks.

Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.

Digestive and central nervous system side effects are dose related.

If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day).

If side effects persist at this lower dosage, the administration of pentoxifylline should be discontinued.