Pentoxifylline

Indications

INDICATIONS AND 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 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.

Dosage and administration (summary)

DOSAGE AND 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.

Contraindications

CONTRAINDICATIONS 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.

Pregnancy

Pregnancy Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD. No evidence of fetal malformation was observed.

Storage and supply

HOW SUPPLIED 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) .

Source: Pentoxifylline (Pentoxifylline) — US FDA prescribing information, 2025-11-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.