Bosentan Taro

/ Taro International Ltd

Pulmonary arterial hypertension: Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In adult patients, 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.
Systemic sclerosis with ongoing digital ulcer disease: Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis. 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. 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. There are no data on the safety and efficacy in patients under the age of 18 years.
Please refer to the license holder for further details

Primary pulmonary arterial hypertension or secondary to scleroderma or other connective tissue disease. To reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.

* Hypersensitivity to the active substance or to any of the excipients
* Moderate to severe hepatic impairment i.e. Child-Pugh Class B or C
* Baseline values of liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal.
* Concomitant use of cyclosporine A.
* Pregnancy. Women of childbearing potential who are not using reliable methods of contraception.
For full details see prescribing information.

Please refer to the license holder for further details

Please refer to the license holder for further details

Please refer to the license holder for further details

Please refer to the license holder for further details

Please refer to the license holder for further details