Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy; may use orally with highly emetogenic chemotherapy (i.e., cisplatin ≥50 mg/m2) or initial and repeat courses of moderately emetogenic chemotherapy, or IV with initial and repeat courses of emetogenic chemotherapy, including high-dose cisplatin.
Postoperative Nausea and Vomiting
Prevention or treatment of postoperative nausea and vomiting.
Routine prophylaxis 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 judgement, 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.
Dosage and Administration
Administration
Administer orally, by IV infusion, or by IV or IM injection.
Oral Administration
Administer orally as conventional tablet, orally disintegrating tablet, or oral solution.
Commercially available oral solution and orally disintegrating tablets may be used interchangeably.
Do not remove orally disintegrating tablet from blister until just prior to dosing; do not push through foil. With dry hands, peel open blister package, and gently remove the tablet; place tablet on tongue to dissolve, and swallow with saliva.
Administration of orally disintegrating tablet with liquid is not necessary.
IV Administration
For prevention of cancer chemotherapy-induced nausea/vomiting, administer by IV infusion using diluted injection or premixed injection.
Administer premixed injection by IV infusion only; do not use flexible plastic container in series connections. For preparation and administration instructions for premixed injection, consult manufacturer’s labeling.
For prevention of postoperative nausea and vomiting, administer undiluted by IV injection.
Dilution
For IV infusion, dilute ondansetron hydrochloride injection in 50 mL of 5% dextrose injection or 0.9% sodium chloride injection; the premixed injection does not require further dilution.
For IV injection, no dilution required.
Rate of Administration
IV infusion: Infuse over 15 minutes.
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
Prevention
Oral
Children 4–11 years of age: Initially, 4 mg given 30 minutes before administration of moderately emetogenic chemotherapy, followed by subsequent 4-mg doses given 4 and 8 hours after first dose. Continue with 4 mg every 8 hours for 1–2 days after completion of chemotherapy.
Children ≥12 years of age: Initially, 8 mg given 30 minutes before administration of moderately emetogenic chemotherapy, followed by a subsequent 8-mg dose given 8 hours after first dose. Continue with 8 mg every 12 hours for 1–2 days after completion of chemotherapy.
IV
Pediatric patients 6 months to 18 years of age: 0.15 mg/kg by IV infusion beginning 30 minutes before start of emetogenic chemotherapy, followed by subsequent 0.15-mg/kg doses given 4 and 8 hours after 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.
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
Prevention
Oral
Initially, 8 mg given 30 minutes before administration of moderately emetogenic chemotherapy, followed by a subsequent 8-mg dose given 8 hours after first dose. Continue with 8 mg every 12 hours for 1–2 days after completion of chemotherapy.
24 mg as a single dose given 30 minutes before administration of single-day highly emetogenic chemotherapy.
IV
0.15 mg/kg by IV infusion beginning 30 minutes before administration of emetogenic chemotherapy, followed by 0.15 mg/kg infused 4 and 8 hours after first dose.
Alternatively, 32 mg as a single dose by IV infusion beginning 30 minutes before administration of emetogenic chemotherapy.
Postoperative Nausea and Vomiting
Prevention
Oral
16 mg as a single dose given 1 hour before induction of anesthesia.
IV
4 mg as a single dose by IV injection (undiluted) immediately before induction of anesthesia.
Limited information available regarding dosage in patients weighing >80 kg.
IM
4 mg as a single dose by IM injection (undiluted) as an alternative to IV administration.
Limited information available regarding dosage in patients weighing >80 kg.
Treatment
IV
4 mg as a single dose by IV injection (undiluted) postoperatively, if nausea and/or vomiting occur shortly after surgery.
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.
Radiation-induced Nausea and Vomiting
Prevention, Usual Dosage
Oral
Usually, 8 mg 3 times daily.
Prevention, for Total Body Irradiation
Oral
8 mg 1–2 hours before each fraction of radiotherapy administered each day.
Prevention, for Single High-dose Fraction Radiation to Abdomen
Oral
8 mg 1–2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1–2 days after completion of radiotherapy.
Prevention, for Daily Fractionated Radiation to Abdomen
Oral
8 mg 1–2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Special Populations
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.
Renal Impairment
No dosage adjustment required, but no experience to date with continuation beyond the first day of therapy.
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