Applies to the following strength(s): 62.5 mg ; 125 mg
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Pulmonary Hypertension
greater than or equal to 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: increase to a maintenance dose of 125 mg twice daily
less than 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: continue dosing of 62.5 mg twice daily
Usual Pediatric Dose for Pulmonary Hypertension
Full Term Neonate: Oral: 1 mg/kg/dose orally twice daily short-term use (2 to 16 days) in three full term neonates has been reported. In the initial report, two full term neonates (8 days and 14 days old) with persistent pulmonary hypertension of the newborn (PPHN) and transposition of the great arteries received bosentan prior to cardiac surgery; patients also received other therapies. A case report describes the use of bosentan monotherapy for PPHN in a full term neonate as primary course of treatment initiated at 29 hours of life; therapy was weaned after 72 hours through the following dose reductions: 0.5 mg/kg/dose orally twice daily followed by 0.5 mg/kg once daily and subsequent discontinuation at 96 hours of treatment.
1 month to 12 years:
less than 10 kg: Initial: 1 to 2 mg/kg orally twice daily for 4 weeks; increase to maintenance dose of 2 to 4 mg/kg orally twice daily.
10 to 20 kg: Initial: 31.25 mg orally daily for 4 weeks; increase to maintenance dose of 31.25 mg orally twice daily.
over 20 to 40 kg: Initial: 31.25 mg orally twice daily for 4 weeks; increase to maintenance dose of 62.5 mg orally twice daily.
over 40 kg: Initial: 62.5 mg orally twice daily for 4 weeks; increase to maintenance dose of 125 mg orally twice daily.
over 12 years:
less than 40 kg: 62.5 mg orally twice daily.
40 kg or more: 62.5 mg orally twice daily for 4 weeks; increase to maintenance dose of 125 mg twice daily.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Due to the potential for serious liver injury, bosentan should be avoided in patients with moderate or severe liver impairment. In addition, it should generally be avoided in patients with elevated aminotransferases (greater than 3 times the upper limit of normal) since monitoring liver injury in such patients may be more difficult.
Dosage adjustments are necessary in patients developing aminotransferase abnormalities. The following guidelines should be practiced with respect to elevations in ALT/AST levels: If ALT/AST levels are greater than 3 and 5 times or less the upper limit of normal (ULN), the results should be confirmed by another aminotransferase test. If confirmed, reduce the daily dose or interrupt treatment and monitor aminotransferase levels at least every 2 weeks. If the aminotransferase levels return to pretreatment values, continue or reintroduce the treatment as appropriate. If the ALT/AST levels are greater than 5 and 8 times or less ULN, confirm results by another aminotransferase test. If confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks. Once the aminotransferase levels return to pretreatment values, consider reintroduction of the treatment. If ALT/AST levels are greater than 8 times the ULN, treatment should be stopped and reintroduction should not be considered. There is no experience with reintroduction of bosentan in such circumstances.
If bosentan is reintroduced, it should be at the starting dose and aminotransferase levels should be checked within 3 days and thereafter according to the recommendations above.
If aminotransferase elevations are accompanied by clinical symptoms of liver injury (e.g., nausea, vomiting, fever, abdominal pain, jaundice, lethargy, fatigue) or increases in bilirubin are greater than or equal to 2 times ULN, treatment should be stopped.
No dosage adjustment is recommended based on race. No differences in pharmacokinetics were observed in a pharmacokinetic study conducted in Japanese and Caucasians.
Due to the potential for serious liver injury, including rare cases of liver failure, liver aminotransferase levels must be measured prior to initiation of treatment and then monthly thereafter.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
Bosentan should be given in the morning and evening with or without food.
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