Comfora
trial impact

Warning and Precautions

General

Pentosan polysulphate has a weak anticoagulant (1/15 of the activity of heparin) activity. Incidence of rectal haemorrhage has been reported at a daily dose of 300 mg. Bleeding complications of ecchymosis, epistaxis and gum haemorrhage have also been reported. It is necessary to evaluate the patients who are about to undergo invasive procedures or those having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, t-PA,streptokinase, high-dose aspirin or nonsteroidal anti-inflammatory drugs) for haemorrhage. Patients with diseases such as aneurysms ,thrombocytopenia, haemophilia, gastrointestinal ulcerations,polyps or diverticula require a detailed evaluation before initiating pentosan polysulphate therapy. Pentosan polysulphate should be prescribed with caution to patients with a history of heparin-induced thrombocytopenia. Pentosan polysulphate may cause alopecia. Alopecia started within the first 4 weeks of treatment in clinical trials with pentosan. .Alopecia areata limited to a single scalp area was the most common variety reported in 97% of the cases.