Active Ingredient: Ondansetron
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
5 - 5 mg per m² of body surface area (BSA)
From 5 To 5 mg per m² of body surface area (BSA) once every day
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below.
In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluid and infused over not less than 15 minutes.
Weight-based dosing results in higher total daily doses compared to BSA-based dosing.
Ondansetron injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid and infused intravenously over not less than 15 minutes.
There are no data from controlled clinical trials on the use of ondansetron in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of ondansetron for radiotherapy-induced nausea and vomiting in children.
Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The intravenous dose must not exceed 8 mg.
Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
BSA-based dosing for Chemotherapy – Children aged ≥6 months and adolescents:
| BSA | Day 1a,b | Days 2–6b |
|---|---|---|
| <0.6m² | 5mg/m² i.v. plus | 2mg syrup every 12 hours |
| 2mg syrup after 12 hrs | ||
| ≥0.6 m² to ≤1.2 m² | 5mg/m² i.v. plus | 4mg syrup or tablet every 12 hrs |
| 4mg syrup or tablet after 12 hrs | ||
| >1.2m² | 5mg/m² or 8mg IV plus | 8mg syrup or tablet every 12 hours |
| 8mg syrup or tablet after 12 hours |
a The intravenous dose must not exceed 8mg.
b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
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