Chemotherapy induced nausea and vomiting (CINV)

Indication for Ondansetron

Population group: Suitable for both men and women, only minors (0 - 18 years old)

For this indication, competent medicine agencies globally authorize below treatments:

5 mg/m² once

Route of admnistration

Intravenous

Defined daily dose

5 - 5 mg per m² of body surface area (BSA)

Dosage regimen

From 5 To 5 mg per m² of body surface area (BSA) once every day

Detailed description

CINV in children aged ≥6 months and adolescents

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.

Dosing by BSA

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:

BSADay 1a,bDays 2–6b
<0.6m²5mg/m² i.v. plus2mg syrup every 12 hours
2mg syrup after 12 hrs
≥0.6 m² to ≤1.2 m²5mg/m² i.v. plus4mg syrup or tablet every 12 hrs
4mg syrup or tablet after 12 hrs
>1.2m²5mg/m² or 8mg IV plus8mg 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.

Active ingredient

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known.

Read more about Ondansetron

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