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Palset

Palset

palonosetron

Manufacturer:

Intas

Distributor:

Accord Healthcare
Concise Prescribing Info
Contents
Palonosetron HCl
Indications/Uses
Prevention of acute nausea & vomiting associated w/ highly or moderately emetogenic cancer chemotherapy in adults & paed patients ≥1 mth.
Dosage/Direction for Use
IV Adult 250 mcg as single IV bolus over 30 sec approx 30 min before start of chemotherapy. Childn & adolescent (1 mth-17 yr) 20 mcg/kg as single 15-min IV infusion beginning approx 30 min before start of chemotherapy. Max total dose: 1,500 mcg.
Contraindications
Special Precautions
Monitor patients w/ history of constipation or signs of subacute intestinal obstruction following administration. Caution in patients who have or are likely to develop prolongation of QT interval including patients w/ personal or family history of QT prolongation, electrolyte abnormalities, CHF, bradyarrhythmias, conduction disturbances & in patients taking anti-arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities. Correct hypokalemia & hypomagnesemia prior to 5-HT3-antagonist administration. Reports of serotonin syndrome w/ use of 5-HT3 antagonists either alone or in combination w/ other serotonergic drugs (including SSRIs & SNRIs). Appropriate observation of patients for serotonin syndrome-like symptoms. Do not use to prevent or treat nausea & vomiting in days following chemotherapy if not associated w/ another chemotherapy administration. Caution patients when driving or operating machines since palonosetron may induce dizziness, somnolence or fatigue. Patients w/ ESRD undergoing haemodialysis. Not to be used in pregnant women unless considered essential. Discontinue breastfeeding during therapy. Safety & efficacy have not been established in childn <1 mth. Limited data on use in prevention of nausea & vomiting in childn <2 yr.
Adverse Reactions
Headache, dizziness; constipation, diarrhoea.
Drug Interactions
Serotonin syndrome w/ serotonergic drugs including SSRIs & SNRIs.
MIMS Class
Antiemetics / Supportive Care Therapy
ATC Classification
A04AA05 - palonosetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Form
Palset soln for IV inj 50 mcg/mL
Packing/Price
5 mL x 1's
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