Acansole Tablet 400mg (Amisulpride)

Adult dose

Adults 1) For acute psychotic episodes, the recommended dose is 400 ~ 800mg per day, up to a maximum of 1,200mg per day. Doses exceeding 1,200mg per day should not be used because their safety has not been established. When positive and negative symptoms occur together, adjust the dose to achieve optimal control of the positive symptoms. When negative symptoms predominate, the recommended daily dose is 50∼300 mg. The dose should be adjusted for each individual. The optimal dose is approximately 100mg per day. 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 per day. Dose titration is not necessary when initiating treatment with this medicine; the dose should be adjusted according to the individual response. The maintenance dose 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 whose creatinine clearance is 30∼60 mL/min, and reduce the dose to 1/3 in those whose creatinine clearance is 10∼30 mL/min. As specific data are unavailable, do not administer this medicine to patients with severe renal impairment (creatinine clearance ＜ 10 mL/min).

This drug can cause a serious side effect known as neuroleptic malignant syndrome during use, so if symptoms such as high fever, muscle rigidity, or altered consciousness occur, the medication should be stopped immediately. It can worsen symptoms in patients with Parkinson's disease, so it should be used cautiously and only when necessary. It may affect the heart, prolonging the QT interval and leading to dangerous arrhythmias; therefore, patients with heart disease or electrolyte imbalances must be carefully checked and monitored before taking this medication. Elderly dementia patients may have an increased risk of death, so it must be used with special care. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be closely monitored. Prolactin levels may increase, so patients with a history of breast cancer or family history should undergo regular examinations. Do not use in certain patient populations, including pregnant or breastfeeding women, children under 15, and patients with severe renal impairment, and avoid administration if there is a hypersensitivity to the medication. There are many drug interactions, particularly with medications that can cause cardiac arrhythmias and levodopa; concurrent use should be avoided, and use with alcohol may enhance sedative effects, increasing risks while driving or operating machinery. Regular monitoring is required for prolonged use, including ECG and blood sugar tests, and dose adjustments or gradual discontinuation are recommended. This medication may cause various side effects such as drowsiness, anxiety, nausea, weight gain, etc.; if any unusual symptoms occur, immediate consultation with healthcare professionals is necessary.

High fever, muscle rigidity, autonomic nervous instability, consciousness impairment, increased creatine phosphokinase levels, extrapyramidal symptoms (tremor, rigidity, bradykinesia, hypersalivation, inability to sit still, dyskinesia), drowsiness, acute muscle hypertonia (spasmodic torticollis, ocular motor seizures, jaw opening disorder), tardive dyskinesia, seizures, insomnia, anxiety, restlessness, hypersexuality dysfunction, constipation, nausea, vomiting, dry mouth, excessive lactation due to increased serum prolactin levels, amenorrhea, gynecomastia, mastalgia, erectile dysfunction, anhedonia, 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 adenoma, leukopenia, neutropenia, agranulocytosis, hypertriglyceridemia, hypercholesterolemia, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, confusion, extrapyramidal disorder, hyperkinesia, tremor, hypertonia, ocular motor seizures, speech disorder, dizziness, muscle tonus disorders, headache, movement disorders, thought disturbances, delirium, weakness, increased sweating, visual disturbances, frequent urination, restlessness, muscle hypertonia, muscle hypotonia, tremors, drowsiness, dyspnea, eating disorders, drowsiness, sedation, coma, hypotension

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature, between 1 and 30 degrees Celsius.

Appearance

White oblong film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)