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Ondansetron Hydrochloride

ONDANSETRON HYDROCHLORIDE

Manufacturer: QPharma Inc

Score: 141.0

Quick Summary

Ondansetron is a 5-HT3 receptor antagonist used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, moderately emetogenic chemotherapy, radiotherapy, and postoperative nausea and/or vomiting. It is available in various forms, including oral solution, tablets, and injectable solutions. The recommended dosage varies depending on the indication, age, and renal function of the patient. Ondansetron has been shown to be effective in preventing nausea and vomiting in these settings, but it can cause adverse reactions such as headache, constipation, and diarrhea. Special considerations are needed for patients with severe hepatic impairment, pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy
  • Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy
  • Prevention of nausea and vomiting associated with radiotherapy
  • Prevention of postoperative nausea and/or vomiting

Important Safety Information

Warning

Ondansetron can cause serious adverse reactions, including serotonin syndrome, myocardial ischemia, and hypersensitivity reactions.

Contraindications

  • Hypersensitivity to ondansetron or any of its components
  • Concomitant use of apomorphine

Adverse Reactions

  • Headache
  • Constipation
  • Diarrhea
  • Serotonin syndrome
  • Myocardial ischemia
  • Hypersensitivity reactions

Dosing Recommendations

General Guidance

Patients with severe hepatic impairment should not exceed a total daily dose of 8 mg.

Highly emetogenic cancer chemotherapy

Adult Dose

24 mg administered 30 minutes before the start of chemotherapy

Pediatric Dose

Not established

Moderately emetogenic cancer chemotherapy

Adult Dose

8 mg administered 30 minutes before the start of chemotherapy, with subsequent 8-mg doses 8 hours after the first dose

Pediatric Dose

12-17 years: 8 mg administered 30 minutes before the start of chemotherapy, with subsequent 8-mg doses 8 hours after the first dose; 4-11 years: 4 mg administered 30 minutes before the start of chemotherapy, with subsequent 4-mg doses 4 and 8 hours after the first dose

Radiotherapy

Adult Dose

8 mg administered 1-2 hours before radiotherapy, with subsequent 8-mg doses every 8 hours after the first dose

Pediatric Dose

Not established

Postoperative nausea and/or vomiting

Adult Dose

16 mg administered 1 hour before induction of anesthesia

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings
  • Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis

Nursing Mothers

  • It is not known whether ondansetron is excreted in human milk

Pediatric Use

  • The safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy

Geriatric Use

  • A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects
  • No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects

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