Company
- Treatment with Tracleer®should only be initiated and monitored by a physician experienced in the treatment of PAH
- Treatment should be initiated at a dose of 62.5 mg bid for 4 weeks increasing to a 125 mg bid maintenance dose thereafter. Tracleer®tablets should be taken in the morning and evening, with or without food
- No dose adjustments are necessary in cases of mild hepatic impairment, in renal impairment or in patients aged > 65 years
- Although safety and efficacy in children under 12 years of age have not be substantially documented, the following regimen has been employed43:
Dosing regimen
Body weight (kg) | Initiation dose (4 weeks) | Maintennance dose |
10 - ≤ 20 | 31.25 mg bid | 31.25 mg bid |
20 - ≤ 40 | 31.25 mg bid | 62.5 mg bid |
> 40 kg | 62.5 mg bid | 125 mg bid |
