Ondansetron Kabi Dosage/Direction for Use

Posology: Chemotherapy and Radiotherapy induced nausea and vomiting (CINV and RINV): Adults: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron Kabi should be flexible in the range of 8-32 mg a day and selected as shown as follows.
Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by oral (tablets or syrup), intravenous or intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, the recommended intravenous (IV) dose of ondansetron is 8 mg and should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection, immediately before treatment, followed by 8 mg orally twelve hourly.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment.
Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given either by oral, intravenous or intramuscular administration. Ondansetron Kabi has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy: A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy; A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy, followed by two further intravenous injection (in not less than 30 seconds) or intramuscular doses of 8 mg four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours; A maximum initial intravenous dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see Special precautions for disposal and other handling under Cautions for Usage) and infused over not less than 15 minutes immediately before chemotherapy.
A single dose greater than 16 mg must not be given due to dose dependent increase of QT-prolongation risk (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
The selection of dose regimen should be determined by the severity of the emetogenic challenge. The efficacy of Ondansetron Kabi 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, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment.
For oral administration, refer to the prescribing information of Ondansetron tablets.
Paediatric Population: CINV in children and adolescents (aged 6 months to 17 years): The dose for CINV can be calculated based on body surface area (BSA) or weight - see as follows. 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 (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Ondansetron Kabi should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see Special precautions for disposal and other handling under Cautions for Usage) and infused intravenously over not less than 15 minutes.
There are no data from controlled clinical trials on the use of Ondansetron Kabi in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Ondansetron Kabi for radiotherapy-induced nausea and vomiting in children.
Dosing by BSA: Ondansetron Kabi should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The single intravenous dose must not exceed 8 mg.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 2).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (See Table 2.)

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Dosing by bodyweight: Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Ondansetron Kabi should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The single intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 3).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (See Table 3.)

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Elderly: In patients 65 to 74 years of age, the dose schedule for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Special precautions for disposal and other handling under Cautions for Usage) and infused over 15 minutes.
In patients 75 years of age or older, the initial intravenous dose of Ondansetron Kabi should not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Special precautions for disposal and other handling under Cautions for Usage) and infused over 15 minutes. The initial dose of 8 mg may be followed by two further intravenous doses of 8 mg, infused over 15 minutes and given no less than four hours apart. (See Pharmacology: Pharmacokinetics under Actions.)
Patients with Renal Impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with Hepatic Impairment: Clearance of Ondansetron Kabi is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded and therefore parenteral or oral administration is recommended.
Patients with Poor Sparteine/Debrisoquine Metabolism: The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
Post-operative nausea and vomiting (PONV): Adults: For the prevention of PONV, ondansetron can be administered orally or by intravenous or intramuscular injection. The recommended dose is as a single dose of 4 mg given by intramuscular or slow intravenous injection at induction of anaesthesia.
For treatment of established PONV, a single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.
Paediatric Population: PONV in children and adolescents (aged 1 month to 17 years): For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of Ondansetron Kabi 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 of Ondansetron Kabi 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.
There are no data on the use of Ondansetron Kabi in the treatment of PONV in children below 2 years of age.
Elderly: There is limited experience in the use of Ondansetron Kabi in the prevention and treatment of PONV in the elderly, however Ondansetron Kabi is well tolerated in patients over 65 years receiving chemotherapy.
Patients with Renal Impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with Hepatic Impairment: Clearance of Ondansetron Kabi is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded and therefore parenteral or oral administration is recommended.
Patients with Poor Sparteine/Debrisoquine Metabolism: The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.