Boryung Aripiprazole Tablet 10mg

Adult dose

1. Schizophrenia - Adults 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, which is the time required to reach steady state. Maintenance treatment: The efficacy of maintenance treatment for schizophrenia was demonstrated in a clinical trial comparing a dose of 15 mg per day with placebo for relapse prevention 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 treatment. Switching from another antipsychotic medication When switching from an existing antipsychotic medication to this drug, it is most appropriate to start this drug while gradually reducing the dose of the existing medication. The period of concomitant administration of most antipsychotic medications should be minimized. 2. 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 depending on clinical response. Doses exceeding 30 mg per day were not evaluated in clinical trials. Maintenance treatment: The efficacy of maintenance treatment for bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this drug (as monotherapy at 15 mg or 30 mg per day) for at least 6 weeks. Patients should be reassessed regularly to determine the need for maintenance treatment. 3. Adjunctive treatment of major depressive disorder - Adults The recommended initial dose for adult patients taking an antidepressant is 2~5mg once daily, with or without food. The efficacy of this drug 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 no more than 5mg at intervals of at least 1 week. Maintenance treatment: Maintenance treatment as adjunctive therapy for major depressive disorder has not been evaluated. Patients should be reassessed regularly to determine the need for maintenance treatment. 6. Dose adjustment considering CYP450 interactions Dose adjustment is recommended for CYP2D6 poor metabolizers and patients taking a CYP3A4 inhibitor, a CYP2D6 inhibitor, or a strong CYP3A4 inducer (see Table 1). If concomitant medication is discontinued, adjust the aripiprazole dose to the previously administered dose; when a CYP3A4 inducer is discontinued, adjust the dose over 1~2 weeks. Thereafter, the dose may be adjusted according to clinical response. 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 therapy for major depressive disorder, it should be administered without dose adjustment.

Child dose

Schizophrenia - Adolescents (13-17 years) The recommended dose is 10 mg once daily, with or without food. Doses of 10 mg and 30 mg per day were studied in adolescent (13-17 years) patients. 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 5 mg increments. However, a dose of 30 mg per day was not more effective than a dose of 10 mg per day. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. Treatment of manic and mixed episodes associated with bipolar disorder - Children (10-17 years) The recommended dose as monotherapy is 10 mg once daily, 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 5 mg increments. Maintenance treatment has not been evaluated in pediatric patients with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Irritability associated with autistic disorder - Children (6-17 years) Efficacy has been demonstrated at doses of 5 mg to 15 mg per day in pediatric patients (6-17 years) with autistic disorder. The recommended initial dose is 1 mg or 2 mg per day, and the dose should be increased to 5 mg per day; if needed, it may then be increased 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 drug should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in pediatric patients with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Tourette's disorder - Children (6-18 years) Efficacy has been demonstrated at doses of 2 mg to 20 mg per day in pediatric patients (6-18 years) with Tourette's disorder. The initial dose is 2 mg per day, and the dose should be gradually increased in 5 mg increments at intervals of at least 2 weeks. The dose of this drug should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in pediatric patients with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance treatment.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders. Therefore, it is essential to closely monitor the patient's condition while taking this medication, and family members or guardians should also carefully observe any behavioral changes in the patient. Additionally, this medication can cause a serious side effect known as neuroleptic malignant syndrome, so if symptoms such as high fever, muscle rigidity, or changes in consciousness occur, immediate medical attention should be sought. Long-term use of this medication may lead to irreversible abnormal motor symptoms known as tardive dyskinesia, hence it is important to use the minimal effective dose for the shortest duration. Special caution is also necessary for dementia patients and the elderly, as there may be an increased risk of cerebrovascular accidents such as strokes. Diabetic patients or those at risk of hyperglycemia should regularly monitor their blood glucose levels, and patients with a risk of thrombosis should assess risk factors and take preventive measures before and during treatment with this medication. Furthermore, this medication should not be administered to patients with allergic reactions or lactose intolerance, and caution is needed for patients with orthostatic hypotension, seizure history, and cognitive or motor dysfunction. Drowsiness or dizziness may occur during treatment, so caution should be exercised when driving or operating hazardous machinery. Various side effects such as weight gain, gastrointestinal symptoms, headaches, insomnia, anxiety, tremors, and muscle rigidity may occur during treatment, and patients should consult healthcare professionals if any abnormal symptoms arise.

• Suicidal thoughts
• suicidal behavior
• anxiety
• restlessness
• panic attacks
• insomnia
• irritability
• hostility
• aggression
• impulsiveness

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature to safely preserve the drug's efficacy.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle