Palonosetron Hydrochloride Prefilled Syringe

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by antineoplastic chemotherapy: Administer palonosetron 0.25 mg once by intravenous injection over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg once by intravenous injection over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended for 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 must be avoided, even if the likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg once by intravenous injection over at least 10 seconds as soon as nausea and vomiting occur. 3. No dosage adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data for 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) 1) Prevention of acute nausea and vomiting induced by antineoplastic chemotherapy: Administer palonosetron 0.02mg/kg (maximum 1.5mg) once by intravenous infusion over at least 15 minutes, 30 minutes before the start of 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 for the prevention of nausea and vomiting induced by antineoplastic chemotherapy in infants (under 24 months) are limited.

This medication should not be used in patients with known allergic reactions to this medication or its components. Patients who have previously exhibited allergic reactions to similar drugs should use this medication with caution. This medication may slow intestinal transit time, so patients with constipation or symptoms of bowel obstruction should be monitored carefully. When used in combination with other serotonergic medications, a serious side effect known as serotonin syndrome may occur, so patients should be monitored closely during concurrent administration. This medication is used for the prevention or treatment of nausea and vomiting induced by chemotherapy and has been reported to cause side effects such as headache, constipation, diarrhea, dizziness, and fatigue in clinical trials. It can affect the cardiovascular system, potentially causing heart rhythm abnormalities or changes in blood pressure, so caution is needed. Dizziness or drowsiness may occur during driving or operating machinery, so caution is required. This medication should only be used during pregnancy when clearly needed, and breastfeeding mothers should consult with their doctor regarding the use of this medication. It can also be used in children and the elderly, but safety and efficacy data are limited, so caution is advised. In case of overdose, as there is no specific antidote, immediate consultation with medical professionals and supportive treatment is necessary. This medication should be stored away from light and freeze, kept at room temperature, and should be checked for discoloration or foreign substances before administration.

headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, severe constipation, non-sustained tachycardia, bradycardia, hypotension, hypertension, myocardial infarction, premature ventricular contractions, sinus tachycardia, sinus arrhythmia, ventricular premature contractions, QT prolongation, allergic dermatitis, rash, motion sickness, tinnitus, burning sensation in the eyes, amblyopia, dyspepsia, dry mouth, hiccups, abdominal bloating, weakness, fever, systemic heat sensation, flu-like syndrome, elevated AST, elevated ALT, increased bilirubin, hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, loss of appetite, arthralgia, drowsiness, hypersomnia, sensory disturbances, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, itching, abnormal movements, pain at the injection site, skin disorders, dehydration, ECG QT prolongation, sinus bradycardia, tachycardia, blood pressure drop, arrhythmia, ventricular premature contractions, generalized edema, decreased T wave amplitude on ECG, decreased platelet count, upper abdominal pain, excessive salivation, decreased intestinal motility, chills, elevated liver enzyme levels, hypokalemia, respiratory depression, laryngospasm, anemia, electrolyte imbalance, cough, wet cough, urticaria, shoulder pain, shoulder discomfort, musculoskeletal pain, myalgia, severe pain, bladder distension, urethral dysfunction, dysuria, fatigue, chest discomfort, postoperative pain, procedural pain, postoperative anemia, wound discharge, hypersensitivity reaction, injection site reaction, leukopenia, general weakness, death, nausea, stomatitis, palpitation, numbness, increased sweating, lymphedema, dry cough, epigastric discomfort, neck/shoulder pain, numbness, asthenia, taste disturbances, febrile neutropenia, abdominal discomfort, unspecified seizure, cystitis, dysuria, boils, edema, frequent urination, limb pain, upper respiratory infection, dyschromia, palm/sole erythema and sensory disturbance, changes in nails, postoperative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, kidney impairment, nocturia, facial flushing, acne, female perineal pain, dysphagia, flank pain, sore throat, oral opening dysfunction, oral pain, gingivitis, gum bleeding, decreased red blood cells, generalized edema, mucositis, vaginitis, weight loss, weight gain, pancreatitis, dental damage, hemorrhoids, toothache, cold, nasal congestion, nosebleed, runny nose, hair loss, pain, migraine, pneumonia, dry skin, skin rash, yawning, anal bleeding, anal pain, hematuria, melena, eosinophilia, neutrophilia, shortness of breath, erythema, flushing, pleural effusion, acute kidney failure, shock, chest pain, atrioventricular block, heart disease, prolonged coagulation time, delayed prothrombin time, decreased prothrombin activity, drowsiness, tremors

This medication should be stored at room temperature between 1 to 30 degrees Celsius, and it is important to store it in a sealed container to prevent air from entering. To maintain the effectiveness of the medication, it should also be stored in a dark place to avoid exposure to light.

Appearance

A colorless and transparent liquid in a colorless and transparent prefilled syringe.

Package unit

5 prefilled syringes/box [1.5mL/prefilled syringe], 1 prefilled syringe/box [5mL/prefilled syringe]