Auctusetron

Ondansetron 2ml/4mg

Introduction

Antiemetic; selective, a first-generation inhibitor of type 3 serotonergic (5-HT3) receptors.

Uses for Ondansetron

  • 1) Cancer Chemotherapy-induced Nausea and Vomiting

  • 2) Postoperative Nausea and Vomiting

  • 3) Prevention of postoperative nausea and vomiting

Routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.

Recommended for patients who, in the clinician's judgment, must avoid nausea and/or vomiting postoperatively, even when anticipated incidence is low.

Radiation-induced nausea and vomiting

Prevention of nausea and vomiting associated with radiation, either total body irradiation or single high-dose fraction or daily fractionated radiation to the abdomen.

Ondansetron Dosage and Administration - administer orally, by IV infusion,or by IV or IM injection.

IV Administration

  • 1) For prevention of cancer chemotherapy-induced nausea/vomiting, administer by IV infusion using diluted injection

  • 2) For prevention of postoperative nausea and vomiting, administer undiluted by IV injection.

Dilution

  • 1) For IV infusion, dilute ondansetron hydrochloride injection in 50 mL of 5% dextrose injection or 0.9% sodium chloride injection.

  • 2) For IV injection, no dilution required .

Rate of Administration

  • 1) IV infusion: Infuse over 15 minutes.

  • 2) IV injection: Inject over a period of ≥ 30 seconds, preferably over 2-5 minutes.

  • IM Administration: For prevention of postoperative nausea and vomiting in adults, may administer undiluted by IM injection as an alternative to IV injection. (See Postoperative Nausea and Vomiting under Dosage and Administration.)

Dosage

Available as ondansetron hydrochloride dihydrate (for oral or IV use) and as ondansetron base (orally disintegrating tablets); dosage expressed in terms of ondansetron.

Pediatric Patients

Cancer Chemotherapy-induced Nausea and Vomiting - IV

Pediatric patients 6 months to 18 years of age: 0.15 mg/kg (maximum 16 mg per dose) by IV infusion beginning 30 minutes before the start of emetogenic chemotherapy, followed by subsequent 0.15-mg/kg doses given 4 and 8 hours after the first dose.

Postoperative Nausea and Vomiting - Prevention - IV

Infants and children 1 month to 12 years of age weighing ≤40 kg: 0.1 mg/kg as a single dose by IV injection immediately before or after induction of anesthesia.

Children ≤12 years of age weighing >40 kg: 4 mg as a single dose by IV injection immediately before or after induction of anesthesia.

Treatment - IV

Infants and children 1 month to 12 years of age weighing ≤40 kg: 0.1 mg/kg as a single dose by IV injection postoperatively, if nausea and/or vomiting occur shortly after surgery.

Children ≤12 years of age weighing >40 kg: 4 mg as a single dose by IV injection postoperatively, if nausea and/or vomiting occur shortly after surgery.

The efficacy of a second dose administered postoperatively after a single, prophylactic, preinduction IV dose has failed to achieve adequate control of postoperative nausea and vomiting has not been evaluated in children; such repeat doses are not effective in adults.

Adults

Cancer Chemotherapy-induced Nausea and Vomiting - IV

0.15 mg/kg (maximum 16 mg per dose) by IV infusion beginning 30 minutes before administration of emetogenic chemotherapy, Single IV dose of 32 mg no longer recommended (see Cardiac Effects under Cautions); efficacy and safety of alternative single-dose IV regimens for prevention of cancer chemotherapy-induced nausea and vomiting not established. followed by 0.15 mg/kg infused 4 and 8 hours after first dose.

Children ≤12 years of age weighing >40 kg: 4 mg as a single dose by IV injection postoperatively, if nausea and/or vomiting occur shortly after surgery.

The efficacy of a second dose administered postoperatively after a single, prophylactic, preinduction IV dose has failed to achieve adequate control of postoperative nausea and vomiting has not been evaluated in children; such repeat doses are not effective in adults.

Postoperative Nausea and Vomiting - IV

  • 1) 4 mg as a single dose by IV injection (undiluted) immediately before induction of anesthesia.

  • 2) Limited information available regarding dosage in patients weighing >80 kg.

  • 3) If adequate control of postoperative nausea and vomiting is not achieved after a single, prophylactic, preinduction IV dose, a second IV dose postoperatively does not provide additional control of nausea and vomiting.

  • 4) If nausea and/or vomiting occur shortly (within 2 hours) after surgery in a patient who did not receive prophylactic antiemetic therapy, 4 mg as a single dose by IV injection (undiluted) postoperatively

IM

  • 1) 4 mg as a single dose by IM injection (undiluted) as an alternative to IV administration.

  • 2) Limited information available regarding dosage in patients weighing >80 kg.

  • 3) Radiation-induced Nausea and Vomiting

  • 4) Prevention, Usual Dosage

Prescribing Limits - Pediatric Patients

Cancer Chemotherapy-induced Nausea and Vomiting - Prevention - IV:

0.15 mg/kg (maximum 16 mg per dose). (See Cardiac Effects under Cautions.)

Prescribing Limits - Adults

Cancer Chemotherapy-induced Nausea and Vomiting - Prevention - IV :

0.15 mg/kg (maximum 16 mg per dose). (See Cardiac Effects under Cautions.)

Special Populations:

  • 1) Hepatic Impairment: Do not exceed total daily dosage of 8 mg (parenteral or oral) in patients with severe hepatic impairment (Child-Pugh score ≥10); no experience to date with continuation beyond the first day of IV therapy.

  • 2) Renal Impairment: No dosage adjustment required, but no experience to date with continuation beyond the first day of therapy.

  • 3) Geriatric Patients: No dosage adjustment required.