Arabil Tablet 2 mg (Aripiprazole (Unmodified))

Adult dose

1. Schizophrenia Adults: The recommended initial dose is 10 mg or 15 mg once daily, regardless of meals. For the treatment of schizophrenia, the dose of this medicine may be adjusted within a range of 10-30 mg per day. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment: The efficacy of maintenance treatment for schizophrenia was demonstrated in a clinical trial assessing relapse versus placebo at a dose of 15 mg once daily in patients with schizophrenia who had been stabilized on another antipsychotic for at least 3 months. Patients should be reassessed periodically to determine the need for maintenance treatment. Switching from another antipsychotic: When switching from an existing antipsychotic to this medicine, it is most appropriate to initiate this medicine while gradually reducing the dose of the existing medication. The period of concomitant use of most antipsychotics should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder Adults: The recommended initial dose, as monotherapy or as adjunctive therapy to lithium or valproate, is 15 mg once daily, regardless of meals. The dose may be increased to 30 mg per day according to clinical response. Doses above 30 mg per day have not been evaluated in clinical trials. Maintenance treatment: The efficacy of maintenance treatment in bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this medicine (15 mg or 30 mg per day as monotherapy) for at least 6 weeks. Patients should be reassessed periodically to determine the need for maintenance treatment. 3. Adjunctive treatment of major depressive disorder — Adults The recommended initial dose for adults taking an existing antidepressant is 2~5mg once daily, regardless of meals. The efficacy of this medicine as an adjunctive treatment for major depressive disorder has been established at doses of 2~15mg per day. The dose should be increased gradually, by no more than 5mg at intervals of at least 1 week. Maintenance treatment: Maintenance treatment as an adjunct for major depressive disorder has not been evaluated. Patients should be reassessed periodically to determine the need for maintenance treatment. 6. Dosage adjustment considering CYP450 interactions Dosage adjustment is recommended for patients who are CYP2D6 poor metabolizers and for patients taking a CYP3A4 inhibitor, a CYP2D6 inhibitor, or a strong CYP3A4 inducer (see Table 1). When concomitant medication is discontinued, adjust the dose of aripiprazole to the previous dose; when a CYP3A4 inducer is discontinued, adjust the dose over 1~2 weeks. The dose may then be adjusted according to clinical response (see Precautions for Use, Interactions). Table 1. Dosage adjustment in CYP2D6 poor metabolizers and patients taking a CYP2D6 inhibitor, CYP3A4 inhibitor, or CYP3A4 inducer CYP2D6 poor metabolizers: 1/2 the usual dose Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): 1/2 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

1. Schizophrenia — Adolescents (13-17 years): The recommended dose is 10 mg once daily, regardless of meals. Doses of 10 mg and 30 mg per day have been studied in adolescent patients (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 5 mg increments. However, 30 mg per day was not more effective than 10 mg per day. Maintenance treatment has not been evaluated in adolescents with schizophrenia. Patients should be reassessed periodically to determine the need for maintenance treatment. Since long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. 2. Treatment of manic and mixed episodes associated with bipolar disorder — Children (10-17 years): The recommended dose as monotherapy is 10 mg once daily, regardless of meals. 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 periodically to determine the need for maintenance treatment. Since long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. 4. Irritability associated with autistic disorder — Children (6-17 years): The efficacy of this medicine 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 1mg or 2mg once daily, increased to 5 mg per day, and thereafter, if needed, 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 medicine should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in pediatric patients with autistic disorder. Patients should be reassessed periodically to determine the need for maintenance treatment. Since long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. 5. Tourette's disorder — Children (6-18 years): The efficacy of this medicine 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, with gradual increases in 5mg increments at intervals of at least 2 weeks. The dose of this medicine 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 periodically to determine the need for maintenance treatment. Since long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly.

This medication may increase the risk of suicide in children, adolescents, and young adults with depression or psychiatric disorders, so careful monitoring is necessary during use. If mood changes, suicidal thoughts, or abnormal behaviors occur during treatment, immediate notification to medical staff is essential, and family members or caregivers should closely observe the patient. This medication may cause a serious neurological side effect known as Neuroleptic Malignant Syndrome. If symptoms such as high fever, muscle rigidity, altered consciousness, or irregular heartbeats occur, immediate treatment is required. Prolonged use may result in tardive dyskinesia, which presents as involuntary abnormal movements, and if such symptoms appear, consultation with healthcare professionals is recommended. In elderly patients with dementia, this medication should not be used as it may increase the risk of stroke and mortality related to cerebrovascular accidents. Due to the potential for elevated blood sugar or worsening diabetes, diabetic patients or those at risk should have their blood sugar monitored regularly. There is a risk of venous thromboembolism, which can cause blood circulation disorders; precautions should be taken for patients with thrombotic risk factors. Patients allergic to this medication or those with lactose intolerance should not take it. Caution is advised when driving or operating dangerous machinery while taking this medication, as it may cause orthostatic hypotension (decrease in blood pressure upon standing) and impair judgment or physical ability. Temperature regulation may be impaired, so take care in hot conditions or during intense exercise. Elderly patients or those with dementia at risk for dysphagia (difficulty swallowing) or aspiration pneumonia should be particularly cautious. Patients at risk of suicide need particularly careful monitoring and management at the initiation of treatment, and should be prescribed the minimum effective dose to prevent overdose. Side effects may include nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia, drowsiness, fatigue, changes in appetite, weight gain, tremors, muscle stiffness, excessive salivation, etc. If any unusual symptoms or discomfort occur during medication, immediate consultation with healthcare professionals is needed.

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

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius, maintaining room temperature.

Appearance

Green rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle