Maxialok Prefilled Injection (Palonosetron Hydrochloride)

Adult administration

1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg intravenously once over at least 30 seconds, 30 minutes before starting chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended in patients expected to have a low likelihood of postoperative nausea and vomiting. Administration of this drug is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the probability of its occurrence is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, administer 0.075 mg intravenously once over at least 10 seconds. No separate dose adjustment is necessary for elderly patients or patients with hepatic or renal impairment. There are no clinical data in patients with end-stage renal disease undergoing dialysis. This drug must not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of this drug.

Child administration

Children (2 months and older): Prevention of acute nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.02 mg/kg (up to 1.5 mg) by intravenous infusion once over at least 15 minutes, 30 minutes before starting chemotherapy. The safety and efficacy of this drug in neonates have not been established (no data are available). Data on the use of this drug to prevent nausea and vomiting induced by anticancer chemotherapy in infants (under 24 months) are limited.

This medication should not be used in patients with allergic reactions to this drug or its components. Patients who have shown allergic reactions to other similar medications should use caution when taking this drug. This medication can slow bowel movements, so patients who have constipation or symptoms of bowel obstruction should be closely monitored during administration. Patients taking other serotonin-related medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) should be cautious due to the risk of serotonin syndrome. This medication is used to prevent nausea and vomiting due to chemotherapy or to prevent and treat nausea and vomiting postoperatively. Side effects may include headaches, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, and allergic dermatitis, rashes, motion sickness, tinnitus, burning sensations in the eyes, amblyopia, dyspepsia, dry mouth, hiccups, abdominal bloating, weakness, fever, generalized warmth, flu-like syndrome, hyperkalemia, electrolyte disturbances, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, joint pain, drowsiness, hypersomnia, paresthesia, anxiety, euphoria, urinary retention, and venous discoloration. Cardiac-related adverse reactions such as changes in heart rate, blood pressure changes, and arrhythmias have been reported, but most have not been clearly linked to this drug. Dizziness or drowsiness may occur during treatment, so caution is advised when driving or operating machinery. When used with other drugs that may prolong the QT interval, cardiac status should be carefully monitored. It should only be used in pregnant women if absolutely necessary, and in breastfeeding, consideration should be given to the possibility of the drug being transmitted to breast milk and its potential effects on the infant. Limited information is available regarding its use in children and the elderly, but dosage adjustment is generally not required in the elderly. In cases of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms; dialysis is not effective. This medication should be stored away from direct sunlight and at a temperature between 1 and 30 degrees Celsius, checking for discoloration or foreign substances before use and disposing of any remaining solution. The potential for drug interactions with this medication is low; however, caution is needed when used in combination with specific medications. If any unusual symptoms occur during use, immediate consultation with a healthcare professional is necessary.

• Headache
• constipation
• diarrhea
• dizziness
• fatigue
• abdominal pain
• insomnia
• nonpersistent tachycardia
• bradycardia
• hypotension

This medication should be stored in a cool room temperature, specifically at temperatures between 1 and 30 degrees Celsius. It should be kept in a sealed container to prevent air exposure and should be protected from direct light. Proper storage helps to maintain the efficacy of the drug for a longer period.

Appearance

A colorless, transparent liquid contained in a colorless, transparent prefilled syringe.

Package unit

1.5mL X 5 prefilled syringes, 5mL X 1 prefilled syringe