Tracleer Dosage/Direction for Use

Method of administration: Tablets are to be taken orally morning and evening, with or without food. The film-coated tablets are to be swallowed with water.
Patients should be advised not to swallow the desiccant found in the white high-density polyethylene bottles.
Posology: Pulmonary arterial hypertension: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Adults: In adult patients, Tracleer 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 Tracleer after treatment interruption (see Precautions).
Paediatric population: Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of Tracleer above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see Pharmacology: Pharmacokinetics under Actions). Increasing the dose or the dosing frequency will likely not result in additional clinical benefit. However, no dosing recommendation for bosentan in children aged 1 year and older can be made at this time.
Management in the event of clinical deterioration of PAH: In the event of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite Tracleer treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered. However, some patients who show no response after 8 weeks of treatment with Tracleer may respond favourably after an additional 4 to 8 weeks of treatment.
In the event of late clinical deterioration despite treatment with Tracleer (i.e., after several months of treatment), the treatment should be re-assessed. Some patients not responding well to 125 mg twice daily of Tracleer may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily. A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Discontinuation of treatment: There is limited experience with abrupt discontinuation of Tracleer in patients with PAH. No evidence for acute rebound has been observed. However, to avoid the possible occurrence of harmful clinical deterioration due to potential rebound effect, gradual dose reduction (halving the dose for 3 to 7 days) should be considered. Intensified monitoring is recommended during the discontinuation period.
If the decision to withdraw Tracleer is taken, it should be done gradually while an alternative therapy is introduced.
Special populations: Hepatic impairment: Tracleer is contraindicated in patients with moderate to severe liver dysfunction (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions). No dose adjustment is needed in patients with mild hepatic impairment (i.e., Child-Pugh class A) (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with renal impairment. No dose adjustment is required in patients undergoing dialysis (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is required in patients over the age of 65 years.