Boryeong Aripiprazole Tablet 5 mg

Adult dose

Adults with schizophrenia: The recommended initial dose is 10 mg or 15 mg once daily, with or without food. For the treatment of schizophrenia, the dose may be adjusted within the range of 10-30 mg per day. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance therapy for adults with schizophrenia: The efficacy of maintenance treatment for schizophrenia was established in a clinical trial comparing relapse rates with placebo at a dose of 15 mg per day in patients with schizophrenia who had been stabilized on another antipsychotic medication for at least 3 months. Patients should be reassessed regularly to determine the need for maintenance therapy. Switching from another antipsychotic: When switching from an existing antipsychotic medication to this medication, it is most appropriate to start this medication while gradually reducing the dose of the existing medication. The period of overlap with most antipsychotic medications should be minimized. Treatment of manic and mixed episodes associated with bipolar disorder, adults: The recommended initial dose, as monotherapy or adjunctive therapy with lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg per day according to clinical response. Doses exceeding 30 mg per day have not been evaluated in clinical trials. Maintenance therapy for adults with bipolar disorder: The efficacy of maintenance therapy for bipolar I disorder was established in a clinical trial in patients stabilized with this medication for at least 6 weeks (as monotherapy at 15 mg or 30 mg per day). Patients should be reassessed regularly to determine the need for maintenance therapy. Adjunctive treatment for major depressive disorder, adults: The recommended initial dose for adults taking an existing antidepressant is 2~5mg once daily, with or without food. The efficacy of this medication as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg per day. The dose should be increased gradually in increments of 5mg or less, at intervals of at least 1 week. Maintenance therapy for adults with major depressive disorder: Maintenance therapy as an adjunctive treatment for major depressive disorder has not been evaluated. Patients should be reassessed regularly to determine the need for maintenance therapy. CYP2D6 poor metabolizers: 1/2 of the usual dose Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): 1/2 of the usual dose Strong CYP3A4 inducers (e.g., carbamazepine, rifampin): 2 times the usual dose over 1~2 weeks However, when aripiprazole is used as adjunctive treatment for major depressive disorder, it should be administered without dose adjustment.

Child dose

Adolescents with schizophrenia (13-17 years): The recommended dose is 10 mg per day, with or without food. Doses of 10 mg and 30 mg per day have been studied in adolescents (13-17 years). The initial daily dose was 2 mg, increased to 5 mg after 2 days and then to 10 mg after another 2 days. Thereafter, the dose was increased in increments of 5 mg. However, a dose of 30 mg per day was not more effective than a dose of 10 mg per day. Maintenance therapy has not been evaluated in adolescents with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. Treatment of manic and mixed episodes associated with bipolar disorder, children (10-17 years): The recommended dose as monotherapy is 10 mg per day, with or without food. Efficacy has been demonstrated at doses of 10 mg or 30 mg per day in children (10-17 years) with bipolar I disorder. The initial dose is 2 mg per day, increased to 5 mg after 2 days and then to 10 mg after another 2 days. Thereafter, the dose should be increased in increments of 5 mg. Maintenance therapy has not been evaluated in children with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. Irritability associated with autistic disorder, children (6-17 years): Efficacy has been demonstrated in children (6-17 years) with autistic disorder at doses of 5 mg to 15 mg per day. The recommended initial dose is 1mg or 2mg per day, increased to 5 mg per day and, if necessary, thereafter to 10 mg or 15 mg per day. Dose adjustments up to 5 mg per day should be made gradually at intervals of at least 1 week. The dose of this medication should be individualized according to tolerability and response. Maintenance therapy has not been evaluated in children with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. Tourette's disorder, children (6-18 years): Efficacy has been demonstrated in children (6-18 years) with Tourette's disorder at doses of 2 mg to 20 mg per day. The initial dose is 2 mg per day, with gradual increases in increments of 5mg at intervals of at least 2 weeks. The dose of this medication should be individualized according to tolerability and response. Maintenance therapy has not been evaluated in children with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly.

This drug may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses. During treatment with this medication, the patient's condition should be closely monitored, and family members or guardians should watch for changes in the patient's behavior. This drug may rarely cause a serious side effect known as neuroleptic malignant syndrome, which includes symptoms such as high fever, muscle rigidity, changes in mental state, and autonomic instability. If such symptoms occur, the medication should be stopped immediately and medical attention sought. Long-term use of this medication may lead to tardive dyskinesia, an irreversible extrapyramidal symptom. This is particularly more common in elderly patients and women. If symptoms appear, consultation with a doctor may be necessary for medication adjustment. Using this drug in elderly patients with dementia may increase the risk of cerebrovascular events such as strokes and death. Therefore, this medication is not safely prescribed to patients with dementia. This drug may raise blood sugar levels, so patients with diabetes or those at risk for diabetes should regularly monitor their blood sugar. If symptoms of hyperglycemia appear, they should notify healthcare professionals immediately. While taking this medication, the risk of thrombosis may increase, so patients with risk factors for thrombosis should be carefully managed. This drug should not be administered to patients with certain genetic lactose intolerance nor to those with hypersensitivity. Patients with orthostatic hypotension, a history of seizures, or impaired judgment or motor abilities should use this medication with caution, as dizziness or drowsiness may occur during treatment. Care should be taken when driving or operating dangerous machinery. This drug may impair the ability to regulate body temperature, so excessive exercise or exposure to high-temperature environments should be avoided, along with proper hydration and management. Caution should be exercised when using this medication in patients at risk of dysphagia or aspiration pneumonia. While taking this medication, symptoms like anxiety, agitation, insomnia, aggression, and impulsive behavior may appear. If these symptoms worsen, consultation with healthcare professionals is necessary. Common side effects reported during treatment include nausea, vomiting, constipation, headaches, dizziness, drowsiness, fatigue, weight gain, increased salivation, tremors, akathisia, and more. The risk of side effects may vary according to dosage and treatment duration, so it is essential to take the lowest effective dose for the shortest duration as directed by a physician. If any unusual symptoms or side effects occur, consult a doctor immediately for appropriate action.

• Suicidal thoughts
• suicidal behavior
• anxiety
• agitation
• panic attacks
• insomnia
• irritability
• hostility
• aggression
• impulsivity

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1°C and 30°C at room temperature.

Appearance

Blue rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle