Palonosetron Hydrochloride Injection (Paroxifril)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg intravenously as a single dose over at least 30 seconds, 30 minutes before starting chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously as a single dose 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 likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg intravenously as a single dose over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose 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

2. Children (2 months and older) 1) Prevention of acute nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.02mg/kg (maximum 1.5mg) by intravenous infusion as a single dose over at least 15 minutes, 30 minutes before starting chemotherapy. Neonates: The safety and efficacy of this drug have not been established (no data are available). Infants (under 24 months): Data on the use of this drug for the prevention of nausea and vomiting induced by anticancer chemotherapy are limited.

This medication should not be administered to patients who are hypersensitive to this drug or any of its components. Also, it should be administered cautiously to patients who are hypersensitive to other selective 5-HT3 receptor antagonists, and patients with a history of constipation or subacute bowel obstruction should be monitored closely as it may prolong colon transit time and worsen constipation. A serious side effect known as serotonin syndrome may occur when this drug is used in combination with other serotonergic medications, so patients must be closely monitored during concomitant use. Dizziness, drowsiness, and fatigue may occur after administration, so caution is advised when driving or operating machinery. There may be a potential risk of QT interval prolongation related to cardiac side effects, so administration to patients with a prolonged QT interval or those taking medications that could prolong the QT interval should be handled with care. This medication should only be given to pregnant women when absolutely necessary, and if breastfeeding, careful consideration should be given to whether to discontinue breastfeeding due to the possibility of the drug passing into breast milk. Safety and efficacy in pediatric patients or adolescents under the age of 18 have not been established sufficiently, so caution is warranted for use. No special dosage adjustment is necessary for elderly patients; however, careful monitoring is recommended. There is no specific antidote in cases of overdose, so supportive treatment should be provided according to symptoms, and dialysis is not effective. This medication should be stored at room temperature (1 to 30℃) protected from light and avoiding freezing, and prior to administration, discoloration or particulate matter must be checked. Any remaining solution after opening should be discarded, and adverse reactions such as headaches, constipation, diarrhea, dizziness, and fatigue have been reported, so if such symptoms arise, consultation with a healthcare provider is necessary.

Headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, severe constipation, nonsustained tachycardia, bradycardia, hypotension, hypertension, myocardial infarction, premature ventricular contractions, sinus tachycardia, sinus arrhythmia, ventricular ectopy, QT prolongation, allergic dermatitis, rash, motion sickness, tinnitus, burning sensation in the eyes, amblyopia, dyspepsia, dry mouth, hiccup, abdominal distension, weakness, fever, generalized warmth, influenza-like syndrome, increased AST, increased ALT, increased bilirubin, hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, paresthesia, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, itching, abnormal movements, injection site pain, skin disorders, ECG QT prolongation, sinus bradycardia, tachycardia, hypotension, arrhythmia, generalized edema, ECG T wave amplitude reduction, decreased platelet count, upper abdominal pain, excessive salivation, decreased intestinal motility, chills, increased liver enzyme levels, hypokalemia, respiratory depression, laryngospasm, anemia, dehydration, electrolyte imbalance, cough, wet cough, abdominal bloating, urticaria, shoulder pain, shoulder discomfort, musculoskeletal pain, myalgia, severe pain, bladder dilation, urethral dysfunction, dysuria, fatigue, chest discomfort, postoperative pain, procedural pain, postoperative anemia, wound exudate, hypersensitivity reaction, injection site reaction, leukopenia, general weakness, death, nausea, stomatitis, sputum disorders, chest pain, hepatotoxicity, hemoptysis, axillary pain, tuberculosis, hypercholesterolemia, pelvic pain, excessive skin pigmentation, oral ulcer formation, muscle weakness, acute liver failure, eye inflammation, monocytosis, palpitations, desensitization, back pain, increased sweating, tremors, lymphedema, dry cough, epigastric discomfort, neck/shoulder pain, numbness, myasthenia, taste disturbance, febrile neutropenia, abdominal discomfort, unspecified seizures, cystitis, dysuria, boils, edema, frequent urination, limb pain, upper respiratory infection, pigmentation disorders, palm/sole erythematous sensation abnormality, nail changes, postoperative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, renal impairment, nocturia, facial flushing, acne, female perineal pain, dysphagia, flank pain, mouth opening dysfunction, oral pain, gingivitis, gum bleeding, decreased red blood cells, generalized edema, mucositis, vaginitis, weight loss, weight gain, pancreatitis, dental damage, hemorrhoids, toothache, nasal cold, nasal congestion, nosebleed, runny nose, hair loss, migraine, pneumonia, dry skin, skin rash, yawning, rectal bleeding, rectal pain, hematuria, melena, eosinophilia, neutrophilia, dyspnea, erythema, flush, pleural effusion, acute kidney failure, shock, nausea, drowsiness, tremor, prolonged prothrombin time, decreased prothrombin activity

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. Additionally, it should be stored in a dark place to avoid exposure to light.

Appearance

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

Package unit

1 vial (1.5mL) x 5 prefilled syringes, 1 vial (5mL) x 1 prefilled syringe