Polaris 400 mg (Amisulpride)

Adult dose

○ Adults 1) For an acute psychotic episode, the recommended dose is 400 ~ 800mg daily, and up to 1,200mg daily may be administered. Doses exceeding 1,200mg daily should not be used, as their safety has not been established. When positive and negative symptoms are mixed, adjust the dose to achieve optimal control of the positive symptoms. When negative symptoms predominate, the recommended dose is 50∼300 mg daily. The dose should be adjusted for each individual. The optimal dose is approximately 100mg daily. In general, when the daily dose is 400 mg or less, administer orally once daily; when the daily dose exceeds 400 mg, divide it into 2 doses daily. Dose titration is not necessary when initiating treatment with this medicine, and the dose should be adjusted according to the individual 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 administered. 2) Patients with renal impairment As this medicine is excreted by the kidneys, reduce the dose by half in patients with renal impairment and a creatinine clearance of 30∼60 mL/min, and reduce the dose to 1/3 in patients with a creatinine clearance of 10∼30 mL/min. As no specific data are available, do not administer this medicine to patients with severe renal impairment (creatinine clearance ＜ 10 mL/min).

This medication may cause a serious side effect called neuroleptic malignant syndrome, so if symptoms such as high fever or muscle rigidity occur, notify medical personnel immediately. In patients with Parkinson's disease, caution should be exercised as it may worsen symptoms, and it should only be administered in unavoidable cases. This medicine may prolong the QT interval of cardiac electrical signals, increasing the risk of cardiac arrhythmia; therefore, an electrocardiogram must be obtained before administration if there is a history of heart disease or related risk factors. Caution is necessary when administering to elderly patients with dementia as there is an increased risk of stroke or death. Due to the risk of thromboembolism, this medication should be administered with caution to patients with risk factors for thrombosis. It may increase prolactin levels leading to symptoms such as breast pain or gynecomastia, so close observation is required for patients with a history or family history of breast cancer. Pregnant or breastfeeding women, children under 15 years of age, and patients with severe kidney impairment should not use this medication, and it should not be taken in conjunction with specific dopaminergic drugs. This drug may cause side effects such as drowsiness, insomnia, anxiety, nausea, constipation, and weight gain, potentially impacting daily life. During treatment, regular checks on blood glucose, electrolyte levels, and white blood cell counts should be conducted to monitor for abnormalities. Caution is advised when driving or operating machinery as this medication may impair these activities, and it should not be taken with alcohol. In case of overdose, serious side effects may occur, so medical attention should be sought immediately, and doses should be reduced gradually rather than stopped suddenly.

High fever, muscle rigidity, autonomic nervous system disturbance, consciousness impairment, increased creatine phosphokinase levels, extrapyramidal symptoms (tremor, rigidity, bradykinesia, sialorrhea, inability to sit still, abnormal movements), drowsiness, acute muscle tension abnormalities (catatonic rigidity, eye movement seizures, jaw opening disorder), tardive dyskinesia, seizures, insomnia, anxiety, agitation, hyperprolactinemia leading to galactorrhea, amenorrhea, gynecomastia, breast pain, erectile dysfunction, loss of sensitivity, hyperglycemia, hypotension, bradycardia, allergic reactions, weight gain, increased liver enzymes, immediate-type urticaria, bronchospasm, drug reaction with eosinophilia and systemic symptoms (DRESS), 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 (SIADH), confusion, extrapyramidal disorder, hyperactivity, tremors, agitation, oculogyric crises, speech disorders, dizziness, muscle tone disturbances, headache, movement disorders, thought disturbances, delirium, weakness, milk discharge, increased sweating, visual disturbances, frequent urination, drowsiness, anxiety (excitement), thought disturbances, delirium, weakness, increased sweating, visual disturbances, frequent urination, hypotension, sedation, coma

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness and prevent deterioration.

Appearance

White oblong film-coated tablets

Package unit

60 tablets (10 tablets/PTP x 6)