Pentoxil (Pentoxifylline) - Indications and Dosage

INDICATIONS AND USAGE

Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxil^® 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

The usual dosage of Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) in extended-release tablet form is one tablet (400 mg) three times a day with meals.

While the effect of Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) 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 Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) should be discontinued.

HOW SUPPLIED

Pentoxil^® (Pentoxifylline Extended-release Tablets, USP) is available for oral administration as 400 mg light-pink, unscored, film-coated, capsule-shaped tablets imprinted U-S 027; supplied in bottles of 100 (NDC 0245-0027-11); bottles of 270 (NDC 0245-0027-27); bottles of 500 (NDC 0245-0027-15); bottles of 5000 (NDC 0245-0027-55) and Unit Dose Packs of 100 (NDC 0245-0027-01).

Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

Dispense in well-closed, light-resistant containers.

Protect blisters from light.

Manufactured by
UPSHER-SMITH
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447

Revised 0405