Polaris Tablet 100mg (Amisulpride)

Adult dose

○ Adults 1) For an acute psychotic episode, 400 to 800mg/day is recommended, and up to a maximum of 1,200mg/day may be administered. Doses exceeding 1,200mg/day should not be used because their safety has not been established. When positive and negative symptoms occur together, the dose should be adjusted to optimally control the positive symptoms. When negative symptoms predominate, the recommended dose is 50∼300 mg/day. The dose should be adjusted for each individual. The optimal dose is approximately 100mg/day. In general, when the daily dose is 400 mg or less, administer orally once daily; when the daily dose exceeds 400 mg, divide the dose into 2 administrations per day. Dose titration is not necessary when starting treatment with this medicine, and the dose should be adjusted according to the individual's response. The maintenance dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be used. 2) Patients with renal impairment Because this medicine is excreted by the kidneys, reduce the dose by half in patients with a creatinine clearance of 30∼60 mL/min, and administer one-third of the dose in patients with a creatinine clearance of 10∼30 mL/min. In the absence of specific data, do not administer this medicine to patients with severe renal impairment (creatinine clearance ＜ 10 mL/min).

This medication can cause serious side effects such as neuroleptic malignant syndrome, similar to that of an antipsychotic. These symptoms can include high fever, muscle rigidity, autonomic instability, altered consciousness, and increased serum creatine phosphokinase levels, which can be very dangerous. If high fever occurs during high-dose administration, the use of the drug should be discontinued immediately. Additionally, this medication may exacerbate symptoms in patients with Parkinson's disease, so it should be administered with caution, and should only be used when absolutely necessary. It can affect the heart and prolong the QT interval, which can lead to dangerous cardiac rhythm disorders such as ventricular arrhythmias. Patients with bradycardia, hypokalemia, congenital or acquired prolonged QT interval should be especially cautious. In elderly patients with dementia, the use of this medication may increase the risk of stroke, so careful assessment before treatment is necessary. In elderly patients with dementia-related psychiatric disorders, the mortality rate may increase with this medication, so it should be used with extreme caution. There is also a risk of venous thromboembolism, which occurs when a thrombus forms in a vessel and obstructs blood flow, requiring special attention in patients with thrombotic risk factors. This medication can elevate levels of the hormone prolactin, so patients with a history or family history of breast cancer require close monitoring during treatment. Furthermore, benign pituitary tumors may develop due to increased prolactin levels, so if symptoms such as headaches or visual disturbances occur, immediate testing is required, and if confirmed, the administration of the medication should be stopped. This medication should not be administered to certain patients, particularly those who are hypersensitive to the drug, those with specific renal dysfunction, pregnant or breastfeeding women, children under 15 years of age, and patients currently taking certain dopaminergic medications. Elderly patients, those with slightly impaired renal function, heart conditions or bradycardia, hypokalemia, prolonged QT interval, and those with a history of seizures should be administered the medication with caution. This medication can cause various side effects such as drowsiness, anxiety, nausea, constipation, excessive lactation due to elevated serum prolactin levels, gynecomastia, erectile dysfunction, etc. Rarely, adverse reactions such as hyperglycemia, hypotension, allergic reactions, elevated liver enzymes, hives, and leukopenia have been reported. Long-term administration is recommended to monitor heart condition through electrocardiograms. Patients with diabetes or those at risk of diabetes should regularly monitor their blood glucose levels, and those with a history of seizures should be particularly observed carefully. This medication can cause withdrawal symptoms or a relapse of psychotic symptoms if suddenly discontinued; therefore, the dose should be gradually reduced. Renal function-impaired patients may require dose adjustments, and elderly patients should be cautious of the risks of hypotension or sedation. This medication requires caution when driving or operating machinery, especially since alcohol can enhance the sedative effect and increase risk. Additionally, this medication can cause serious side effects in conjunction with certain drugs, so it should only be taken after consulting a healthcare professional. During pregnancy, its safety has not been established, so it is advisable to avoid use, and in breastfeeding, considerations should be made regarding the administration of the medication or the cessation of breastfeeding. It is not to be administered to children under 15 years of age and is not recommended for those aged 65 or older. In case of overdose, symptoms such as drowsiness, coma, hypotension, and extrapyramidal symptoms may occur, and immediate medical attention is required.

High fever, muscle stiffness, autonomic nervous system disorders, altered consciousness, extrapyramidal symptoms, tremors, rigidity, akinesia, hypersalivation, inability to sit still, dyskinesia, drowsiness, acute muscle hypertonia, spastic torticollis, ocular movement seizures, jaw-opening problems, involuntary movements of the tongue and face, delayed abnormal movements, seizures, insomnia, anxiety, restlessness, abnormal orgasmic function, constipation, nausea, vomiting, dry mouth, increased serum prolactin levels, galactorrhea, amenorrhea, gynecomastia, breast pain, erectile dysfunction, anhedonia, hyperglycemia, hypotension, bradycardia, allergic reactions, weight gain, increased liver enzymes, immediate-type urticaria, bronchospasm, eosinophilia with systemic symptoms, neuroleptic malignant syndrome, Torsade de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest, pulmonary embolism, venous thromboembolism, angioedema, urticaria, benign pituitary tumor, leukopenia, neutropenia, agranulocytosis, hypertriglyceridemia, hypercholesterolemia, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, confusion, extrapyramidal disorders, hyperactivity, tremors, hypertonia, ocular movement seizures, speech disorders, dizziness, muscular dystonia, headache, movement disorders, psychotic symptoms, delirium, weakness, increased sweating, visual disturbances, polyuria, drowsiness, anxiety, psychotic symptoms, delirium, weakness, increased sweating, visual disturbances, polyuria, hypotension, sedation, coma

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The medication should also be stored at room temperature, which is not too hot or too cold, between 1 degree and 30 degrees Celsius.

Appearance

White round tablet

Package unit

60 tablets (10 tablets/PTP x 6)