Tracleer
Tracleer (bosentan) is a dual endothelin receptor antagonist. It blocks the binding of endothelin to both ET-A and ET-B receptors, thereby reducing pulmonary vascular resistance. It is highly regulated due to risks of hepatotoxicity and teratogenicity, requiring enrollment in a restricted distribution program (REMS).
Dosage by Body Weight
Administered orally twice daily, in the morning and evening, with or without food. The typical adult starting dose is 62.5 mg twice daily for 4 weeks, then increased to a maintenance dose of 125 mg twice daily. Pediatric dosing is weight-based for patients 3 years of age and older. Liver function tests and pregnancy tests must be performed monthly.
- Body Weight
- Below 5 kg
- Dose
- Not routine
- Frequency
- Use only if prescribed
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients under 3 years of age or weighing less than 10 kg.
- Body Weight
- 5-7 kg
- Dose
- Not routine
- Frequency
- Use only if prescribed
- Tracking Notes
- Safety and efficacy have not been established in pediatric patients under 3 years of age or weighing less than 10 kg.
- Body Weight
- 8-10 kg
- Dose
- 31.25 mg
- Frequency
- Once daily for 4 weeks, then twice daily
- Tracking Notes
- For pediatric patients aged 3 years and older. Use of dispersible tablets (for oral suspension) is recommended.
- Body Weight
- 11-15 kg
- Dose
- 31.25 mg
- Frequency
- Once daily for 4 weeks, then twice daily
- Tracking Notes
- For pediatric patients aged 3 years and older. Monitor liver aminotransferases monthly.
- Body Weight
- 16-20 kg
- Dose
- 31.25 mg
- Frequency
- Once daily for 4 weeks, then twice daily
- Tracking Notes
- For pediatric patients aged 3 years and older. Weight-based dosing should be adjusted as the child grows.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not routine | Use only if prescribed | Safety and efficacy have not been established in pediatric patients under 3 years of age or weighing less than 10 kg. |
| 5-7 kg | Not routine | Use only if prescribed | Safety and efficacy have not been established in pediatric patients under 3 years of age or weighing less than 10 kg. |
| 8-10 kg | 31.25 mg | Once daily for 4 weeks, then twice daily | For pediatric patients aged 3 years and older. Use of dispersible tablets (for oral suspension) is recommended. |
| 11-15 kg | 31.25 mg | Once daily for 4 weeks, then twice daily | For pediatric patients aged 3 years and older. Monitor liver aminotransferases monthly. |
| 16-20 kg | 31.25 mg | Once daily for 4 weeks, then twice daily | For pediatric patients aged 3 years and older. Weight-based dosing should be adjusted as the child grows. |
Formulation
Purpose
Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity and decrease clinical worsening, and to reduce the number of new active digital ulcers in patients with systemic sclerosis.
Generic Name
BosentanScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.