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palonosetron hydrochloride

PALONOSETRON HYDROCHLORIDE

Manufacturer: Cipla USA Inc.

Score: 145.0

Quick Summary

Palonosetron is a serotonin-3 (5-HT3) receptor antagonist used for the prevention of nausea and vomiting associated with cancer chemotherapy and postoperative nausea and vomiting. It is available in a 0.25mg/5mL single-dose vial and is administered intravenously. The recommended dosage varies based on the condition being treated, with adults typically receiving 0.25mg for chemotherapy-induced nausea and vomiting and 0.075mg for postoperative nausea and vomiting. Pediatric patients require a higher dose, with a maximum of 1.5mg. The drug has been shown to be effective in clinical trials, but may have adverse reactions such as headache, constipation, and QT prolongation. Special considerations are needed for use in pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Prevention of nausea and vomiting associated with cancer chemotherapy
  • Prevention of postoperative nausea and vomiting
  • Effective in clinical trials for chemotherapy-induced nausea and vomiting
  • Approved for use in pediatric patients aged 1 month to less than 17 years

Important Safety Information

Warning

Hypersensitivity reactions, including anaphylaxis, have been reported

Contraindications

  • Hypersensitivity to palonosetron or any of its components

Adverse Reactions

  • Headache
  • Constipation
  • QT prolongation
  • Bradycardia

Dosing Recommendations

General Guidance

No dose adjustment is required for geriatric patients

Chemotherapy-induced nausea and vomiting

Adult Dose

0.25mg as a single dose

Pediatric Dose

20mcg/kg (maximum 1.5mg) as a single dose

Postoperative nausea and vomiting

Adult Dose

0.075mg as a single dose

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • No available data on use in pregnant women
  • Animal studies show no effects on embryo-fetal development

Nursing Mothers

  • No data on presence in human milk
  • Caution advised

Pediatric Use

  • Approved for use in pediatric patients aged 1 month to less than 17 years
  • Higher dose required compared to adults

Geriatric Use

  • No overall differences in safety or effectiveness observed
  • Greater sensitivity in some older individuals cannot be ruled out

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