Solian 400 mg (Amisulpride)

Adult dose

○ Adults 1) For an acute psychotic episode, 400 ~ 800mg daily is recommended, and up to 1,200mg daily may be administered. Do not use doses exceeding 1,200mg daily, as 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 daily. In general, when the daily dose is 400 mg or less, administer orally once daily; when the daily dose exceeds 400 mg, administer in 2 divided doses. Dose titration is not required when starting treatment with this medicine. The dose should be adjusted according to the individual patient'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 As this medicine is excreted by the kidneys, reduce the dose by half in patients with renal impairment when creatinine clearance is 30∼60 mL/min, and reduce the dose to 1/3 when creatinine clearance is 10∼30 mL/min. In the absence of specific data, 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; therefore, if symptoms such as high fever or muscle rigidity occur, treatment with the drug should be discontinued immediately. Additionally, this drug may exacerbate symptoms in patients with Parkinson's disease; therefore, it should be used cautiously in these patients. It can affect the heart and may prolong the QT interval, increasing the risk of arrhythmias; hence, patients with heart disease or those with a long QT interval should be particularly cautious. In elderly patients with dementia, this drug may increase the risk of stroke or death, necessitating careful monitoring and administration in such individuals. Due to the risk of thromboembolism, patients with risk factors for thrombosis should be careful, and monitoring is required for patients with a history of elevated prolactin levels, as this could increase the risk of breast cancer or pituitary tumors. This drug should not be administered to patients with specific diseases or conditions such as pheochromocytoma, severe renal impairment, pregnant or breastfeeding women, or children under 15 years old. Elderly patients, those with mildly impaired renal function, patients with heart diseases, and those with hypokalemia should exercise additional caution when using this medication. While taking this medication, symptoms such as drowsiness or blurred vision may occur, requiring caution during driving or operating machinery, and using it with alcohol may exacerbate these effects. There are numerous interactions with other medications, so it is essential to consult a specialist before combining it with medications that may induce arrhythmias or dopaminergic drugs. It is safest for pregnant or breastfeeding women to avoid using this medication, as using it during pregnancy may lead to abnormal symptoms in newborns, who should be closely monitored. In cases of overdose, symptoms such as drowsiness, sedation, coma, hypotension, and extrapyramidal symptoms may occur, necessitating immediate medical attention for appropriate treatment. This medication should be kept out of reach of children and should not be transferred to other containers to maintain quality.

Leukopenia, Neutropenia, Agranulocytosis, Allergic reactions, Increased serum prolactin levels, Galactorrhea, Amenorrhea, Gynecomastia, Breast pain, Erectile dysfunction, Decreased sensitivity, Benign pituitary tumor, Hyperglycemia, Hypertriglyceridemia, Hypercholesterolemia, Hyponatremia, Syndrome of inappropriate antidiuretic hormone secretion, Insomnia, Anxiety, Nervousness, Hyperarousal dysfunction, Confusion, Extrapyramidal symptoms, Tremor, Rigidity, Reduced movement, Sialorrhea, Inability to sit still, Dyskinesia, Drowsiness, Acute muscle rigidity, Typically, during long-term use, regular involuntary movements of the tongue and/or face, Seizures, Neuroleptic malignant syndrome, Akathisia, Restless legs syndrome, Blurred vision, Bradycardia, QT interval prolongation, Torsades de pointes, Ventricular arrhythmia, Ventricular fibrillation, Cardiac arrest, Sudden death, Hypotension, Hypertension, Pulmonary embolism, Venous thromboembolism, Deep vein thrombosis, Nasal congestion, Aspiration pneumonia, Constipation, Nausea, Vomiting, Dry mouth, Hepatocellular injury, Angioedema, Urticaria, Photosensitivity reaction, Osteopenia, Osteoporosis, Rhabdomyolysis, Increased serum creatine phosphokinase levels, Urinary retention, Falls resulting from drug adverse reactions that interfere with body balance, Neonatal drug withdrawal syndrome, Weight gain, Elevated liver enzymes, Immediate-type urticaria, Bronchospasm, Drug reactions accompanied by eosinophilia and systemic symptoms, Extrapyramidal disorder, Hyperactivity, Tremor, Increased muscle tone, Ocular movement seizures, Speech disorders, Dizziness, Dystonia, Headache, Movement disorders, Drowsiness, Anxiety, Thought disorders, Delirium, Weight gain, Weakness, Breast milk transfer during the breast-feeding period, Gynecomastia, Hyperprolactinemia, Nausea, Vomiting, Gastrointestinal disorders, Increased sweating, Increased salivation, Visual disturbances, Frequent urination, Dizziness, Headache, Anxiety, Thought disorders, Delirium, Weakness, Increased sweating, Visual disturbances, Frequent urination, Drowsiness, Sedation, Coma, Hypotension, Extrapyramidal symptoms

This medicine must be stored in a tightly sealed container to protect it from exposure to air and moisture. It is important to maintain a temperature between 1 to 30 degrees Celsius.

Appearance

White rectangular film-coated tablets

Package unit

60 tablets (10 tablets/blister * 6), 30 tablets/bottle, 100 tablets/bottle