All the Active Ingredient Drugs
Endothelin Receptor Antagonist. Bosentan 62.5 mg, 125 mg. FC Tab 56 X 62.5/125 mg
Pulmonary arterial hypertension: In adult pts., initiate at a dose of 62.5 mg twice daily for 4 weeks and then incr. to maint. dose of 125 mg twice daily.
Systemic sclerosis with ongoing digital ulcer disease: initiate at a dose of 62.5 mg twice daily for 4 weeks and then incr. to maint. dose of 125 mg twice daily. Clinical experience is limited to 6 months.
The ptt’s response to tmt. and need for contin. ther. should be re-evaluated on a regular basis. A careful benefit / risk assessm. should be made, taking into consideration the liver tox. of bosentan. There are no data on the safety and efficacy in pts. under the age of 18 years.
Primary pulmonary arterial HT or second. to scleroderma or other connective tissue disease. To reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer dis.
C/I: Hypersens./ Moder. to sev. hepatic impairm. 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.
/ Concom. use of cyclosporine A
/ Pregn. Women of childbearing potent. who are not using reliable methods of contraception
Endothelin Receptor Antagonist. Bosentan (as monohydrate) 62.5 mg, 125 mg. F.C. TABS.: 60. The tmt. in adults is usually started with 62.5 mg ×2/d for the first 4 wks. Thereafter, the dose may be incr. to 125 mg×2/d, depend. on the react. of the pt.
Child. and adolesc.: The optimal dosage for child. under the age of 12 who suffer from pulmon. arterial hypertens. is unknown.
Treatment of pulmonary arterial hypertension (PAH) in patients of WHO functional class II-IV.
Reduct. in the number of new digital ulcers in pts. with system. sclerosis with active digital ulcer dis.
C/I: Hypersens. Hepat. impair. Women of child bear. age who are not use. appropr. method of contracep. Preg. Transplant/proriatic pts. who are treated with cyclosporine. See lit.
Endothelin Receptor Antagonist. Bosentan 62.5 mg, 125 mg. FC Tabs. 60 X 62.5/125 mg
To be initiated at a dose of 62.5 mg twice/d for 4 weeks and then incr. to the maint. dose of 125 mg twice/d.
Tmt. of pulmonary arterial hypertension (PAH) in pts. of WHO functional class II-IV.
Reduction in the number of new digital ulcers in pts with syst. sclerosis with active digital ulcer dis.
C/I: Hypersens./ Moder. to sev. hepatic impairm.: Child-Pugh class B or C/
Baseline values of liver aminotransferases AST and/or ALT, greater than 3 x the upper limit of normal (ULN)/ Concom. use of cyclosporine A/ Pregn./
Women of childbearing potent. who are not using reliable contracept.
