Ami-Tab 400 mg (Amisulpride)

Adult dose

○ Adults 1) Acute psychotic episode: The recommended dose is 400 ~ 800mg daily, and up to 1,200mg daily may be administered. Do not use doses exceeding 1,200mg daily, 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 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 it orally once daily; when the daily dose exceeds 400 mg, divide it into 2 doses per day. Dose titration is not required when starting 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 and a creatinine clearance of 30∼60 mL/min, and by 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 life-threatening side effect known as neuroleptic malignant syndrome, so if symptoms such as high fever or muscle rigidity appear, the medication should be discontinued immediately. Caution is particularly required in patients with Parkinson's disease, as it may exacerbate symptoms, and it should only be used when absolutely necessary. The drug can prolong the QT interval, which indicates electrical activity of the heart, increasing the risk of cardiac arrhythmias, so patients with heart disease or electrolyte imbalances should be thoroughly checked before administration. There is an increased risk of death when using this medication in elderly patients with dementia, so it should be administered with caution; caution is also necessary for patients at risk of stroke. Elevated prolactin levels in the blood may lead to breast-related disorders or pituitary tumors, so patients with such medical history require close monitoring. This medication should not be used by children under the age of 15, pregnant or breastfeeding women, or patients with severe kidney impairment. Elderly patients, those with mild to moderate kidney impairment, heart disease, or hypokalemia must be particularly careful during administration. This medication can cause various side effects, including drowsiness, anxiety, vomiting, constipation, and weight gain, so if any unusual symptoms occur, patients should inform healthcare professionals. Interactions may occur when taken with other heart-related medications or dopaminergic drugs, so consultation with a doctor is necessary before administration. Taking this medication with alcohol may enhance sedative effects, making it dangerous for driving or operating machinery, so alcohol should be avoided. The use during pregnancy may pose risks of abnormal symptoms in the fetus, so women who could become pregnant must consult with healthcare professionals. In cases of overdose, severe drowsiness, hypotension, or coma may occur, requiring immediate medical attention. This medication should be kept out of reach of children, and transferring it to another container may cause quality degradation or accidents, so caution is advised.

High fever, muscle rigidity, autonomic nervous dysfunction, altered consciousness, increased creatine phosphokinase levels, extrapyramidal symptoms, tremor, rigidity, hypokinesia, excessive salivation, inability to sit still, dyskinesia, drowsiness, acute muscle hypertonia, opisthotonus, eye movement seizures, trismus, delayed dyskinesia, seizures, insomnia, anxiety, restlessness, abnormalities in peak flow function, 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-type urticaria, bronchospasm, eosinophilia, drug reaction with systemic symptoms, neuroleptic malignant syndrome, Torsade 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, hyperactivity, tremor, hypertonia, eye movement seizures, speech disorders, dizziness, dystonia, headache, movement disorders, thought disorders, delirium, weakness, transfer to breast milk, gynecomastia, hyperprolactinemia, gastrointestinal disorders, increased sweating, visual disturbances, polyuria, restlessness, muscle hypertonia, muscle hypotonia, tremors, drowsiness, dyspnea, food intake disorders, drowsiness, sedation, coma, hypotension, extrapyramidal symptoms

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the effectiveness and prevent deterioration of the medication.

Appearance

White rectangular film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle