Ondansetron Hydrochloride

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

General Guidance

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

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