Indications
Moderately emetogenic cancer chemotherapy- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
Highly emetogenic cancer chemotherapy- prevention of acute nausea and vomiting associated with initial and repeat courses
Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
Therapeutic Class
Pharmacology
Dosage
Chemotherapy-Induced Nausea and Vomiting: Dosage for Adults- a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur 30 minutes before the start of chemotherapy. Alternatively 0.5 mg tablet approximately 1 hour before the start of chemotherapy.
Postoperative Nausea and Vomiting: Dosage for Adults- a single 0.075 mg I.V. dose administered over 10 seconds immediately before the induction of anesthesia. In case of 0.5 mg tablet, dose should be determined by the physician.
Administration
Instructions for I.V. Administration-
- It should not be mixed with other drugs
- Flush the infusion line with normal saline before and after administration
- Parenteral drug products should be inspected visually for particulate matter and discoloration before administration
Interaction
Contraindications
Side Effects
The most common adverse reactions of Palonosetron in chemotherapy-induced nausea and vomiting are headache and constipation.
The most common adverse reactions of Palonosetron in postoperative nausea and vomiting are QT prolongation, bradycardia, headache and constipation.
Pregnancy & Lactation
Precautions
- For IV administration only. Not for intradermal, subcutaneous, or IM administration.
- Do not administer if particulate matter, cloudiness, or discoloration is noted.
- Discard any unused solution. Do not save unused solution for later administration.
- Do not mix with other medications.
Use in Special Population
Pediatric Use: Safety and effectiveness in patients below the age of 18 years have not been established. However different clinical trial shows Palonosetron is well tolerated and effective from one month of age.
Geriatric Use: Pharmacokinetics analysis did not reveal any differences in Palonosetron pharmacokinetics between patients ≥ 65 years of age and younger patients (18 to 64 years)
Renal Function Impairment: No dosage adjustments are needed with any degree of renal function impairment.
Hepatic Function Impairment: No dosage adjustments are needed with any degree of hepatic function impairment.
Elderly: No dosage adjustments or special monitoring are needed in elderly patients.
Reconstitutions
Intravenous:
Nausea and vomiting associated with cancer chemotherapy: Physically and chemically stable at concentrations of 5 and 30 mcg/ml in glucose 5%, sodium chloride 0.9%, glucose 5% in lactated Ringer’s for at least 48 hr at room temperature, exposed to light and for 14 days under refridgeration.
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