Palzeron Injection (Palonosetron Hydrochloride)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg by intravenous injection once over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg by intravenous injection 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. This medicine is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the likelihood of its occurrence is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg by intravenous injection once over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose adjustment is necessary for older adults or patients with hepatic or renal impairment. There are no clinical data in patients with end-stage renal disease undergoing dialysis. Do not mix this medicine with other drugs. Flush the infusion line with normal saline before and after administration of this medicine.

Child administration

Pediatric patients (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 once over at least 15 minutes, 30 minutes before the start of chemotherapy. The safety and efficacy of this medicine in neonates have not been established (no data are available). Data on the use of this medicine for the prevention of nausea and vomiting induced by anticancer chemotherapy in infants (under 24 months) are limited.

This medication should not be used in patients with a known allergy to this drug or its ingredients. Patients with a history of allergic reactions to similar classes of drugs should exercise caution when using this medication. This drug may slow down gut movement, so patients with constipation or bowel obstruction symptoms should be monitored closely. The use of this drug with other serotonergic agents may lead to the serious side effect known as serotonin syndrome; consequently, consultation with a physician or pharmacist is necessary if taking such medications. This drug is used to prevent or treat nausea and vomiting, and some side effects such as headache, constipation, diarrhea, dizziness, and fatigue may occur in some patients. Rarely, side effects such as heart rhythm abnormalities, changes in blood pressure, skin rashes, and liver function anomalies have been reported, so any unusual symptoms must be communicated to medical personnel immediately. Caution is advised due to potential dizziness or drowsiness while driving or operating machinery. The safety of this medication in pregnant or breastfeeding women has not been fully established, hence should only be used when absolutely necessary and discussed with a physician. Elderly patients can use this medication at similar doses as adult patients, but monitoring may be required based on their condition. In case of overdose, as there are no specific antidotes, immediate medical attention is necessary for appropriate treatment. Store this medication away from direct sunlight at room temperature, and check for discoloration or contaminants before administration. Unused medication should be disposed of, and one should consult healthcare professionals immediately in case of any adverse reactions or discomfort during medication use.

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, increased AST, increased ALT, increased bilirubin, hyperkalemia, electrolyte changes, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, paresthesia, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, pruritus, dyskinesia, injection site pain, skin disorders, ECG QT prolongation, sinus bradycardia, hypotension, systemic edema, decreased T wave amplitude on ECG, decreased platelet count, upper abdominal pain, excessive salivation, decreased intestinal motility, chills, increased liver enzyme levels, hypokalemia, respiratory depression, laryngeal spasm, anemia, dehydration, electrolyte imbalance, cough, wet cough, abdominal distension, 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 exudate, allergic reaction, injection site reaction, leukopenia, systemic weakness, death, nausea, stomatitis, phlegm diseases, chest discomfort, chest pain, hepatotoxic effects, hemoptysis, axillary pain, tuberculosis, hypercholesterolemia, pelvic pain, hyperpigmentation of the skin, oral ulcer formation, muscle weakness, acute liver failure, ocular inflammation, monocytosis, palpitations, insensitivity, back pain, increased sweating, tremors, lymphedema, dry cough, epigastric discomfort, neck/shoulder pain, numbness, weakness, taste disorder, febrile neutropenia, abdominal discomfort, unspecified seizures, cystitis, dysuria, skin lesions, edema, increased urination, limb pain, upper respiratory infection, pigmentation abnormalities, palm/sole erythema with sensory abnormalities, nail changes, postoperative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, renal impairment, nocturia, facial flushing, acne, female perineal pain, dysphagia, flank pain, sore throat, mouth opening disorder, oral pain, gingivitis, gum bleeding, decreased red blood cells, systemic edema, mucositis, vulvitis, 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, anal bleeding, anal pain, hematuria, melena, eosinophilia, neutrophilia, dyspnea, erythema, flushing, pleural effusion, acute renal failure, shock, atrioventricular block, heart disease, prolonged coagulation time, delayed prothrombin time, reduced prothrombin activity, drowsiness, tremor

This medication should be stored at room temperature between 1 to 30 degrees Celsius in a sealed container to prevent air entry. It is also recommended to keep the drug away from direct light and in a dark place.

Appearance

A colorless, transparent liquid in a colorless, transparent glass vial injection.

Package unit

1 vial (1.5mL/vial, 5mL/vial), 10 vials (1.5mL/vial, 5mL/vial)