Xanthines.

Oxpentifylline [pentoxifylline]

Pentoxifylline 400MG

Modified release tablet.

Trental 400 is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain.

The recommended initial dose is 1 tablet (400 mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. Tablets should be taken with or immediately after meals, and swallowed whole with plenty of water.

Special Cases: In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approximately 30% to 50% may be necessary guided by individual tolerance.

Not recommended.

Trental 400 is contra-indicated in cases where there is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients. Also in patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias.

In patients with hypotension or severe coronary artery disease, Trental 400 should be used with caution, as a transient hypotensive effect is possible and, in isolated cases, might result in a reduction in coronary artery perfusion.

Particularly careful monitoring is required in patients with impaired renal function. In patients with a creatinine clearance of less than 30 ml/min it may be necessary to reduce the daily dose of Trental 400 to one or two tablets to avoid accumulation. In patients with severely impaired liver function the dosage may need to be reduced.

High doses of Trental injection have been shown, in rare cases, to intensify the hypoglycaemic action of insulin and oral hypoglycaemic agents. However, no effect on insulin release has been observed with Trental following oral administration.

Trental 400 may potentiate the effect of anti-hypertensive agents and the dosage of the latter may need to be reduced.

Trental 400 should not be given concomitantly with ketorolac as there is increased risk of bleeding and/or prolongation of prothrombin time.

Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients. Therefore there may be an increase in and intensification of adverse effects of theophylline.

These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown.

Description of selected adverse reactions

* Reports of aseptic meningitis were predominantly in patients with underlying connective tissue disorders

** A few very rare events of bleeding (e.g. skin, mucosa) have been reported in patients treated with Trental with and without anticoagulants or platelet aggregation inhibitors. The serious cases are predominantly concentrated in the gastrointestinal, genitourinary, multiple site and surgical wound areas and are associated with bleeding risk factors. A causal relationship between Trental therapy and bleeding has not been established. Thrombocytopenia has occurred in isolated cases.

sanofi-aventis

(POM)

23 January 2012