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CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV): The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.
Populations: CINV and RINV in Adults: Emetogenic Chemotherapy and Radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.
For oral administration: 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.
For highly emetogenic chemotherapy: a single dose of up to 24 mg Ondansetron taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron may be continued for up to 5 days after a course of treatment.
The recommended dose for oral administration is 8 mg to be taken twice daily.
CINV in Children and Adolescents (aged 3 years to 17 years): The dose for CINV can be calculated based on body surface area (BSA) or weight. 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.
Dosing by BSA: Ondansetron should be administered immediately before chemotherapy as a single IV dose of 5mg/m2.
The IV dose must not exceed 8 mg.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 1).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (See Table 1.)
Click on icon to see table/diagram/imageDosing by body weight: Ondansetron should be administered immediately before chemotherapy as a single IV dose of 0.15 mg/kg.
The IV dose must not exceed 8 mg. On Day 1, two further IV 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 2).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (See Table 2.)
Click on icon to see table/diagram/imageThere are no dosing recommendations for children with BSA <0.6 m2, body weight <10 kg or who are unable to swallow tablets.
CINV and RINV in Elderly: Ondansetron is well tolerated by patients over 65 years of age.
No alteration of oral dose or frequency of administration is required.
Renal Impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.
Hepatic Impairment: Clearance of ondansetron 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 IV or oral should not be exceeded.
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): PONV in Adults: For the prevention of PONV: Ondansetron can be administered orally or by intravenous or intramuscular injection.
For oral administration: 16 mg taken one hour prior to anaesthesia.
For the treatment of established PONV: Intravenous or intramuscular administration is recommended.
PONV in Children and Adolescents (aged 3 years to 17 years): No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose.
There are no data on the use of ondansetron in the treatment of PONV in children below 2 years of age.
Elderly: There is limited experience in the use of Ondansetron in the prevention and treatment of post-operative nausea and vomiting in the elderly, however Ondansetron is well tolerated in patients over 65 years receiving chemotherapy.
Renal Impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.
Hepatic Impairment: Clearance of ondansetron 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 IV or oral should not be exceeded.
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.
Route of Administration: Oral.
