Ondansetron (Paediatric)

PAEDIATRIC DOSING IS RECORDED IN THE paedDose FIELD AND MUST BE VERIFIED AGAINST A CHILDREN'S FORMULARY. INDICATION SCOPE: this SPC covers only CINV (chemotherapy and radiotherapy induced nausea and vomiting) and PONV (post-operative nausea and vomiting). It contains NO regimen for nausea or vomiting from any other cause, so any other use is outside this source and no dose for it has been recorded here. All three CINV intravenous schedules stated as equally effective over the first 24 hours of highly emetogenic chemotherapy: (1) a single dose of 8 mg by slow intravenous injection immediately before chemotherapy; (2) 8 mg by slow intravenous injection or short infusion over 15 minutes immediately before chemotherapy, followed by two further intravenous doses of 8 mg four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours; (3) a maximum initial intravenous dose of 16 mg diluted and infused over not less than 15 minutes immediately before chemotherapy, optionally followed by two additional 8 mg intravenous doses four hours apart. 'The selection of dose regimen should be determined by the severity of the emetogenic challenge.' Efficacy in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg administered prior to chemotherapy. To protect against delayed or prolonged emesis after the first 24 hours, treatment with dosage forms other than intravenous should be continued after a course of treatment. ELDERLY: in patients 65 to 74 years the adult dose schedule can be followed, with all intravenous doses diluted in 50 to 100 ml and infused over 15 minutes; in patients 75 years or older the initial intravenous dose should not exceed 8 mg, and may be followed by two further 8 mg intravenous doses infused over 15 minutes and given no less than four hours apart. POOR SPARTEINE/DEBRISOQUINE METABOLISERS: no alteration of daily dosage or frequency is required. SOURCE COMPLETENESS: eMC section 4.5 (interactions) begins in the captured text but was truncated at the source-fetch limit; sections 4.4 and 4.8 were also truncated.

dosePerKg is left null because the SPC states TWO DIFFERENT per-kg figures for the two indications - 0.15 mg/kg for CINV and 0.1 mg/kg for PONV - so a single number would be unsafe. VERBATIM SPC section 4.2. CINV in children aged 6 months and over and adolescents: 'The dose for CINV can be calculated based on body surface area (BSA) or weight. Weight-based dosing results in higher total daily doses compared to BSA-based dosing.' 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... The total daily dose must not exceed adult dose of 32 mg.' BSA table - BSA less than 0.6 m2: day 1, 5 mg/m2 IV plus 2 mg syrup after 12 hrs; days 2 to 6, 2 mg syrup every 12 hrs. BSA 0.6 m2 or more: day 1, 5 mg/m2 IV plus 4 mg syrup or tablet after 12 hrs; days 2 to 6, 4 mg syrup or tablet every 12 hrs. Dosing by bodyweight: 'Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals. The total daily dose must not exceed adult dose of 32 mg.' Weight table - 10 kg or less: day 1, up to 3 doses of 0.15 mg/kg every 4 hrs; days 2 to 6, 2 mg syrup every 12 hrs. Over 10 kg: day 1, up to 3 doses of 0.15 mg/kg every 4 hrs; days 2 to 6, 4 mg syrup or tablet every 12 hrs. There are no data from controlled clinical trials on the use of ondansetron in the prevention of delayed or prolonged CINV, or for radiotherapy-induced nausea and vomiting, in children. PONV in children aged 1 month and over and adolescents: 'For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.' 'For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose... at a dose of 0.1 mg/kg up to a maximum of 4 mg.' 'There are no data on the use of ondansetron in the treatment of PONV in children below 2 years of age.' Section 4.4 paediatric warnings: paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function; and when calculating the dose on an mg/kg basis and administering three doses at 4-hourly intervals, the total daily dose will be higher than if one single dose of 5 mg/m2 followed by an oral dose is given. Verify against a children's formulary before use.