Preparation
Palostar® Tablet: Each film-coated tablet contains Palonosetron Hydrochloride INN equivalent to 0.5 mg Palonosetron.
Palostar® 0.075 Injection: Each 1.5 ml contains Palonosetron Hydrochloride INN equivalent to 0.075 mg Palonosetron.
Indication
For adults: 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 pediatric patients aged 1 month to less than 17 years: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
Contraindication
For patients known to have hypersensitivity to the drug or any of its components.
Dosage & Administration
Tablet: Dose- 0.5 mg tablet per day.
For Chemotherapy-Induced Nausea and Vomiting: Dosage for Adults- 0.5 mg tablet approximately 1 hour before the start of chemotherapy.
Injection: Adult IV Dose- A single IV dose of 0.075 mg should be administered over 10 seconds. For Postoperative Nausea and Vomiting: Dosage for Adults- A single IV dose of 0.075 mg should be administered over 10 seconds immediately before the induction of anesthesia.
Side Effect
The most common adverse reactions are QT prolongation, bradycardia, headache, and constipation for postoperative nausea and vomiting and headache and constipation for chemotherapy-induced nausea and vomiting.
Precaution
Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Palonosetron should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc.
Drug Interaction
In vitro studies indicated that Palonosetron is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6, or CYP3A4/5. Therefore, drug interactions appear to be low.
Presentation
Palostar® tablet: Each commercial box contains 2x10's tablets in Alu-Alu blister pack.
Palostar® 0.075 Injection: Each commercial box contains 1x5's ampoules in blister pack.
Use Children
Safety and effectiveness in patients below the age of 18 years have not been established.
Use Pregnancy Lactation
Pregnancy category B. Palonosetron should be used during pregnancy only if clearly needed. It is not known whether palonosetron is excreted in human milk.
Overdosage
There is no known antidote to Palonosetron. Overdose should be managed with supportive care. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.
Storage
Store in a cool and dry place, away from light. Store below 30°C temparature. Keep all medicines out of the reach of children.