Solian 200 mg (Amisulpride)

Adult dose

○ Adults 1) For acute psychotic episodes, 400 ~ 800mg per day is recommended, and up to 1,200mg per day may be administered. Do not use doses exceeding 1,200mg per day, 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 per day. Generally, 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 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 used. 2) Patients with renal impairment Because this medicine is excreted by the kidneys, reduce the dose by half in patients with 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 is a type of antipsychotic and requires various precautions during use. Firstly, there is a risk of a serious side effect called Neuroleptic Malignant Syndrome, which may present as high fever, muscle rigidity, and altered consciousness, so patients on high-dose therapy should be particularly cautious. Additionally, there may be a risk of rhabdomyolysis, and immediate consultation with medical personnel is required if symptoms occur. In patients with Parkinson's disease, the symptoms may worsen; hence, it should only be used with caution when absolutely necessary. Regarding the heart, there may be an increased risk of arrhythmia due to QT interval prolongation, so patients with bradycardia or electrolyte imbalances should undergo ECG testing before administration. There is a potential increased risk of stroke and mortality in elderly patients with dementia, thus extra caution is necessary. Also, in patients with thromboembolic risk factors, the possibility of thrombosis should be closely monitored. This drug can raise prolactin levels, increasing the risk of breast cancer and pituitary tumors, therefore patients with relevant medical history require regular examinations. Patients with hypersensitivity or certain conditions (such as pheochromocytoma, severe renal impairment, prolactin-dependent tumors, etc.), children under 15 years of age, pregnant or lactating women should not use this medication. Elderly patients, those with mild to moderate renal impairment, patients with heart disease, and those with hypokalemia require even more careful monitoring during administration. This medication can cause various side effects including drowsiness, blurred vision, insomnia, anxiety, and weight gain; caution should be taken while driving or operating machinery. Particularly, when taken with alcohol, it may enhance the sedative effect which can be dangerous. This medication may interact with several other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. The safety of this medication during pregnancy has not been established, and infants may show abnormal symptoms, so it should be avoided in pregnant or lactating women. In case of overdose, severe symptoms may occur and immediate medical attention is required, as there is no specific antidote. Finally, it is important to store this medication out of reach of children and not to transfer it to another container.

High fever, muscle stiffness, autonomic nervous system anxiety, consciousness impairment, rhabdomyolysis, increased creatine kinase levels, increased serum prolactin levels, excessive milk secretion, amenorrhea, gynecomastia, breast pain, erectile dysfunction, anhedonia, benign pituitary tumors, hyperglycemia, hypertriglyceridemia, hypercholesterolemia, hyponatremia, inappropriate secretion of antidiuretic hormone syndrome, insomnia, anxiety, restlessness, orgasmic dysfunction, confusion, tremor, rigidity, hypokinesia, hypersalivation, inability to sit still, dyskinesia, drowsiness, acute muscle tonicity disorder, abnormal delayed movement, seizures, malignant syndrome due to muscle relaxants, akathisia, restless legs syndrome, blurred vision, bradycardia, prolonged QT interval, Torsade de pointes, ventricular arrhythmias, ventricular fibrillation, cardiac arrest, sudden death, hypotension, hypertension, pulmonary embolism, deep vein thrombosis, nasal congestion, aspiration pneumonia, constipation, nausea, vomiting, dry mouth, hepatocellular damage, angioedema, urticaria, osteopenia, osteoporosis, urinary retention, falls due to impaired body balance, neonatal drug withdrawal syndrome, weight gain, increased liver enzymes, immediate-type urticaria, bronchospasm, drug reactions accompanied by eosinophilia and systemic symptoms, extrapyramidal syndrome, hyperkinesia, tension increase, oculomotor seizures, speech disorder, dizziness, muscle tonicity disorder, headache, movement disorder, thought disorder, delirium, weakness, milk transfer, gynecomastia, hyperprolactinemia, gastrointestinal diseases, increased sweating, increased salivation, visual disturbances, frequent urination, dizziness

This medication may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius room temperature to preserve its efficacy over time.

Appearance

White or almost white round tablets

Package unit

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