Akhansol Tablet 100 mg (Amisulpride)

Adult dose

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 medication may cause a serious side effect known as Neuroleptic Malignant Syndrome; thus, if symptoms such as high fever or muscle rigidity occur, immediate consultation with a healthcare professional is necessary. Extreme caution is required when administered to patients with Parkinson's disease, as symptoms may worsen. This medication can prolong the QT interval, which is part of cardiac electrical activity, increasing the risk of arrhythmia. Therefore, patients with heart disease or electrolyte imbalances must undergo testing before administration. In elderly dementia patients, there may be an increased risk of death, so special care is needed. Patients with a risk of thromboembolism should be closely monitored for thrombosis when this medication is administered. This medication may increase prolactin levels, so patients with a history or family history of breast cancer should have regular check-ups. If a pituitary tumor is suspected, imaging tests should be performed for confirmation, and if a tumor is found, the use of this medication should be discontinued. Patients who have hypersensitivity to this medication, specific kidney function disorders, women who are pregnant or breastfeeding, and children under 15 years old should not use this medication. Elderly patients, those with impaired kidney function, heart disease, and patients with hypokalemia should exercise extra caution when using this medication. This medication may cause various side effects such as drowsiness, anxiety, constipation, nausea, and excessive lactation. If any unusual symptoms occur, the healthcare professional should be informed. Particular attention should be paid to rare side effects such as decreased blood cell count, serious allergic reactions, and cardiac arrhythmias. The risk may increase when this medication is taken with other arrhythmogenic drugs, dopamine agents, or alcohol; therefore, it is crucial to consult with a doctor. Safety has not been established during pregnancy, and unusual symptoms may appear in newborns. Thus, women who are pregnant or may become pregnant should avoid using this medication. If breastfeeding, the medication can be transmitted through breast milk, necessitating discontinuation of breastfeeding or stopping the medication. This medication is not recommended for children under 15 or elderly patients over 65, and special caution is needed in these cases. In case of overdose, symptoms such as drowsiness, hypotension, and coma may occur, requiring immediate emergency treatment. Since there is no antidote, appropriate treatment according to symptoms is necessary. This medication should be kept out of reach of children and should not be transferred to other containers.

High fever, muscle rigidity, autonomic nervous system anxiety, impaired consciousness, increased creatine phosphokinase levels, extrapyramidal symptoms, tremors, rigidity, hypokinesia, sialorrhea, inability to sit still, dystonia, drowsiness, acute muscle tone disorder, tonic seizures, oculomotor seizures, jaw opening disturbance, delayed movement disorders, seizures, insomnia, anxiety, restlessness, hyperesthesia, constipation, nausea, vomiting, dry mouth, increased serum prolactin levels, excessive milk secretion, amenorrhea, gynecomastia, mastalgia, erectile dysfunction, anhedonia, hyperglycemia, hypotension, bradycardia, allergic reactions, weight gain, elevated liver enzymes, immediate-type urticaria, bronchospasm, eosinophilia, systemic symptoms, neuroleptic malignant syndrome, Torsade de pointes, ventricular tachycardia, ventricular arrhythmias, ventricular fibrillation, cardiac arrest, sudden death, pulmonary embolism, venous thromboembolism, deep venous thrombosis, angioedema, urticaria, benign pituitary tumor, leukopenia, neutropenia, agranulocytosis, hypertriglyceridemia, hypercholesterolemia, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, confusion, extrapyramidal disorders, hyperactivity, tension, oculomotor seizures, speech disorders, dizziness, muscle rigidity, headache, movement disorder, thought disorder, delirium, weakness, breastfeeding during the period of weight gain, visual disturbances, frequent urination, restlessness, hypertonia, hypotonia, tremors, drowsiness, dyspnea, eating disorders, drowsiness, sedation, coma, hypotension, extrapyramidal symptoms

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

White round tablet

Package unit

60 tablets (10 tablets/PTP x6)