Ondrin Dosage/Direction for Use

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 Adult: The recommended intravenous (IV) or intramuscular (IM) dose of ONDRIN is 8mg administered immediately before the treatment.
For highly emetogenic chemotherapy, a maximum initial ondansetron of 16mg IV infused over 15 minutes may be used. A single IV dose greater than 16 mg should not be given.
The efficacy of ONDRIN in highly emetogenic chemotherapy may be enhanced by the addition of a single IV dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.
IV doses greater than 8mg and up to a maximum of 16mg must be diluted in 50mL to 100mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection before administration and infused over not less than 15 minutes. ONDRIN doses of 8 mg or less do not need to be diluted and may be administered as a IM or slow IV injection in not less than 30 seconds.
The initial dose of ONDRIN may be followed by 2 additional IV or IM doses of 8mg 2 to 4 hours apart, or by a constant infusion of 1mg/h for up to 24 hours.
Oral treatment is recommended to protect against delayed or prolonged emesis after the first 24 hours.
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.
ONDRIN can be given by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluid (see Instructions for Use under Cautions for Usage) and infused over not less than 15 minutes.
Dosing by BSA: ONDRIN should be administered immediately before chemotherapy as a single IV dose of 5mg/m². The IV dose must not exceed 8mg.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 1). Adult doses must not be exceeded. (See Table 1.)

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Dosing by body weight: ONDRIN 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 maybe given in 4-hourly intervals.
Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 2). Adult dose must not be exceeded. (See Table 2.)

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There 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.
In patients 65 years of age or older, all IV doses should be diluted and infused over 15 minutes and, if repeated, given no less than 4 hours apart.
In patients 65 - 74 years of age, the initial IV dose of ONDRIN 8mg or 16 mg, infused over 15 minutes, may be followed by 2 doses of 8 mg infused over 15 minutes and given no less than 4 hours apart.
In patients 75 years of age or older, the initial IV dose of ONDRIN should not exceed 8mg infused over 15 minutes. The initial dose of 8 mg may be followed by 2 doses of 8 mg, infused over 15 minutes and given no less than 4 hours apart.
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 patient 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 metabolism of sparteine and debrisoquine. Consequently, in such patients repeat dosing will give drug exposure levels no different from those of the general populations. No alteration of daily dosage or frequency of dosing is required.
Post-Operative Nausea and Vomiting (PONV): PONV in Adults: For prevention of post-operative nausea and vomiting, the recommended dose of ONDRIN injection is a single dose of 4 mg by IM or slow IV injection administered at the induction of anesthesia.
For treatment of established post-operative nausea and vomiting a single dose of 4 mg given by IM or slow IV injection is recommended.
PONV in Children and Adolescents (aged 3 - 17 years): For prevention and treatment of PONV in paediatric patients having surgery performed under general anesthesia, ONDRIN may be administered by slow IV 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 anesthesia, or after surgery.
Elderly: There is limited experience in the use of ONDRIN in the prevention and treatment of post-operative nausea and vomiting in the elderly, however ONDRIN 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: IV (Intravenous) or IM (Intramuscular).