Indication

Palonosetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated for:

• 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.

Palonosetron is indicated in pediatric patients aged 1 month to less than 17 years for:

• Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.


Dosage & Administration

Usual dosage: Adult tablet dosage: 0.5 mg (01 tablet) daily. Adult IV dosage: A single IV dose of 0.075 mg should be administered over 10 seconds.

Chemotherapy-induced nausea and vomiting: Adult tablet dosage: 0.5 mg (01 tablet) administered approximately 1 hour prior to the start of chemotherapy. Adult IV dosage: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before the start of chemotherapy.

Radiotherapy-induced nausea and vomiting: A single IV dose of 0.25 mg should be administered over 30 seconds approximately 30 minutes before each week of radiation fraction.

Post-operative nausea and vomiting: A single IV dose of 0.075 mg should be administered over 10 seconds immediately before induction of anesthesia.

Children dosage: (1 month to 17 years): A single IV dose at 20 mcg/kg body weight. Which maximum dose is 1.5 mg.


Use in Specific Populations

Use in pregnancy and lactation: Pregnancy category 'B'. It is not known whether Palonosetron is excreted in breast milk.

Use in elderly patients: No dosage adjustment is recommended in elderly patient ≥ 65 years of age.

Use in children (1 month to 17 years): A single IV dose at 20 mcg/kg body weight which maximum dose is 1.5 mg.

Use in patients with impaired renal and hepatic function: No dosage adjustment is recommended in patients with renal and hepatic dysfunction.


Precautions

Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT3 receptor antagonists.


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