Active Ingredient: Bosentan
Bosentan is indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 62.5 milligrams bosentan, 2 times daily, over the duration of 4 weeks. Afterwards, oral, 125 milligrams bosentan, 2 times daily.
Bosentan treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. The same recommendations apply to re-introduction of bosentan after treatment interruption.
Controlled clinical study experience in this indication is limited to 6 months. The patient’s response to treatment and need for continued therapy should be re-evaluated on a regular basis. A careful benefit/risk assessment should be made, taking into consideration the liver toxicity of bosentan.
It should be taken orally morning and evening, with or without food.
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