Document Code
Issue/Revision No.
Issue Date
Revision Date
Copy No.
Protocol
Bosentan protocol
Prepared By
Name
Title
ANH-DPP-MMS-04
1
15/9/2020
15/9/2022
2
Dr Ghada Ramsis
Chief Pharmacist
Signature
Name
Dr Wael Atia
Dr. Jacqueline Yousef
Title
Head of Pediatric-ICU
Quality Manager
Signature
Reviewed By
Name
Dr. Hamza El Nady
Title
Cardiothoracic surgery consultant
Signature
Approved By
Name
Dr. Ahmed Hanafy
Title
Hospital & medical Director
Signature
Bosentan protocol
Pediatric Dosing in Pulmonary Arterial Hypertension:
-Infants and Children <12 years: Oral: Initial: 1 mg/kg/dose twice daily; increase to a target dose of 2
mg/kg/dose twice daily; maximum dose: 125 mg/dose.
-Children ≥12 years and Adolescents: Oral:
>20 to 40 kg: Initial: 31.25 mg twice daily; increase to a target dose of 62.5 mg twice daily.
>40 kg: Initial: 62.5 mg twice daily; increase to a target dose of 125 mg twice daily.
-Alternate dosing: Manufacturer's labeling:
-Children ≥3 years:
4 to 8 kg: Oral: 16 mg twice daily
>8 to 16 kg: Oral: 32 mg twice daily
>16 to 24 kg: Oral: 48 mg twice daily
>24 to 40 kg: Oral: 64 mg twice daily
-Adolescents:
≤40 kg: Oral: 62.5 mg twice daily
>40 kg: Oral: Initial: 62.5 mg twice daily for 4 weeks; increase to target dose of 125 mg twice
daily.
❖ Adult Dosing in Pulmonary Arterial Hypertension:
<40 kg: Initial and maintenance: 62.5 mg twice daily.
≥40 kg: Initial: 62.5 mg twice daily; after 4 weeks, may increase to a maximum dose of 125 mg
twice daily.
Note: When discontinuing treatment, consider a reduction in dosage
to 62.5 mg twice daily for 3 to 7 days to avoid clinical deterioration, then stop treatment.
❖ Extemporaneous Preparations:
A 6.25 mg/mL oral suspension may be made from nondispersable tablets. Crush three 62.5 mg tablets
in a ceramic mortar. Add a small amount of glycerin and reduce to a fine powder. Add ~10 mL of the
vehicle and triturate; add an additional 10 mL of vehicle and transfer to a calibrated amber bottle.
Rinse the mortar and pestle with 10 mL vehicle and add to bottle to bring the final volume to 30 mL.
Stable for 30 days when stored in amber bottle at room temperature or under refrigeration.
ANH-DPP-MMS-04 Issue/Revision: 01/00
Issue Date: 01/09/2020 Revision Date: 01/09/2022 Page 2 of 2