Amisulpride 200 mg

Adult dose

○ Adults 1) For an acute psychotic episode, the recommended daily dose is 400 ~ 800mg, and up to 1,200mg per day may be administered. Do not use doses exceeding 1,200mg per day, as 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, if the daily dose is 400 mg or less, administer it orally once daily; if the daily dose exceeds 400 mg, administer it in 2 divided doses per day. Dose titration is not required when initiating treatment with this medicine. The dose should be adjusted according to the individual's 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 This medicine is excreted by the kidneys. Therefore, reduce the dose by half in patients with renal impairment and a creatinine clearance of 30∼60 mL/min, and reduce it to 1/3 in patients with a creatinine clearance of 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 medication may cause a serious side effect known as neuroleptic malignant syndrome. This syndrome includes high fever, muscle rigidity, autonomic instability, and altered consciousness, and caution is particularly needed in patients receiving high doses. In patients with Parkinson's disease, it should be used carefully, as it may worsen symptoms, and alternative treatments should be considered if possible. This medication can prolong the QT interval, which indicates the electrical activity of the heart, increasing the risk of cardiac arrhythmias. Caution is especially needed in patients with bradycardia, hypokalemia, or originally prolonged QT interval. In elderly dementia patients, there may be an increased risk of stroke, so caution should be exercised in those with a history of hypertension or cerebrovascular disease. The use of this medication in elderly dementia patients may increase the risk of death, so the risks and benefits should be thoroughly considered upon administration. Patients with risk factors for thromboembolism, particularly venous thromboembolism, should be monitored due to the risk of thrombosis. This medication can increase prolactin hormone levels, raising the risk of breast-related diseases; hence, patients with a history or family history of breast cancer require close observation. If there is a significantly elevated prolactin level or symptoms of a pituitary tumor occur, examination should be performed immediately, and the medication should be discontinued if necessary. This medication should not be used in patients with hypersensitivity to it or those with specific conditions (such as pheochromocytoma, prolactin-dependent tumors, severe renal impairment), pregnant or nursing women, and children under 15 years of age. Elderly patients, patients with slightly impaired renal function, patients with heart disease or electrolyte imbalances, and those with a history of seizures require careful assessment and monitoring before administration. During treatment, side effects such as drowsiness, anxiety, constipation, nausea, vomiting, low blood pressure, and weight gain may occur, and if there are abnormal symptoms, medical consultation should be sought immediately. This medication can interact with other drugs, requiring caution when co-administered with drugs that can induce cardiac arrhythmias, dopaminergic drugs, and alcohol. There is insufficient experience regarding its use during pregnancy, and its safety for the fetus is not established; therefore, nursing should be discontinued or the medication stopped as it can be transmitted through breast milk. In case of overdose, symptoms such as drowsiness, sedation, coma, low blood pressure, and extrapyramidal symptoms may occur. As no specific antidote exists, appropriate treatment should be sought immediately at a medical institution. This medication should be kept out of reach of children, and it is safer not to transfer it to other containers.

High fever, muscle rigidity, autonomic nervous system anxiety, consciousness impairment, extrapyramidal symptoms, tremors, rigidity, bradykinesia, sialorrhea, inability to sit still, movement disorders, drowsiness, acute muscle hypertonia, spasmodic torticollis, ocular motor seizures, jaw opening disorder, delayed dyskinesia, seizures, insomnia, anxiety, agitation, dysregulation of orgasm, constipation, nausea, vomiting, dry mouth, increased serum prolactin levels, galactorrhea, amenorrhea, gynecomastia, mastalgia, erectile dysfunction, anhedonia, hyperglycemia, hypotension, bradycardia, allergic reactions, weight gain, increased liver enzymes, immediate hypersensitivity urticaria, bronchospasm, drug reaction (DRESS), neuroleptic malignant syndrome, Torsades de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest, sudden death, pulmonary embolism, venous thromboembolism, angioedema, urticaria, benign pituitary tumor, leukopenia, neutropenia, agranulocytosis, hypertriglyceridemia, hypercholesterolemia, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, confusion, extrapyramidal disorder, hyperkinesia, increased muscle tone, speech disorders, dizziness, dystonia, headache, movement disorders, thought disturbances, delirium, weakness, transfer of breast milk, increased sweating, visual disturbances, frequent urination, drowsiness, anxiety (agitation), thought disturbances, delirium, weakness, increased sweating, visual disturbances, frequent urination, agitation, increased muscle tone, decreased muscle tone, tremors, sleepiness, dyspnea, eating disorders, drowsiness, sedation, coma, hypotension

This medication should be stored in a tightly sealed container to prevent contamination from air and moisture. Additionally, it is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle