Arabil Tablet 5 mg (Aripiprazole (Unmodified))

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 of this medicine may be adjusted within the range of 10-30 mg daily. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment: The efficacy of maintenance treatment with this medicine for schizophrenia was demonstrated in a clinical trial assessing relapse at a dose of 15 mg daily versus placebo in patients with schizophrenia who had been stabilized with another antipsychotic for at least 3 months. Patients should be periodically reassessed 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 product. The period of concomitant use of most antipsychotics should be minimized. Treatment of manic and mixed episodes associated with bipolar disorder Adults: The recommended initial dose, as monotherapy or adjunctive therapy to lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg daily according to clinical response. Doses above 30 mg daily 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 (as monotherapy at 15 mg or 30 mg daily) for at least 6 weeks. Patients should be periodically reassessed to determine the need for maintenance treatment. Adjunctive treatment of 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 medicine as an adjunctive treatment for major depressive disorder has been established at doses of 2~15mg daily. This medicine should be gradually increased in increments of 5mg or less, 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 periodically reassessed to determine the need for maintenance treatment. Dosage adjustment considering CYP450 interactions: Dosage 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 dose of aripiprazole to the previous dose; when a CYP3A4 inducer is discontinued, adjust the dose over 1~2 weeks. Thereafter, the dose may be adjusted according to clinical response. (See the “Interactions” section under Precautions for Use.) 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

Adolescents with schizophrenia (13-17 years): The recommended dose is 10 mg daily, with or without food. Doses of 10 mg and 30 mg daily were 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 a further 2 days. Thereafter, the dose was increased in increments of 5 mg. However, a dose of 30 mg daily was not more effective than a dose of 10 mg daily. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be periodically reassessed to determine the need for maintenance treatment. Long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully on a regular basis. Treatment of manic and mixed episodes associated with bipolar disorder in children (10-17 years): The recommended dose as monotherapy is 10 mg daily, with or without food. Efficacy has been demonstrated at doses of 10 mg or 30 mg daily in children (10-17 years) with bipolar I disorder. The initial dose is 2 mg daily, increased to 5 mg after 2 days and then to 10 mg after a further 2 days. Thereafter, the dose should be increased in increments of 5 mg. Maintenance treatment has not been evaluated in children with bipolar I disorder. Patients should be periodically reassessed to determine the need for maintenance treatment. Long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully on a regular basis. Irritability associated with autistic disorder in children (6-17 years): This medicine has been shown to be effective at doses of 5 mg to 15 mg daily in children (6-17 years) with autistic disorder. The recommended initial dose is 1mg or 2mg daily; increase to 5 mg daily and, if necessary, thereafter to 10 mg or 15 mg daily. Dose adjustments up to 5 mg daily 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 children with autistic disorder. Patients should be periodically reassessed to determine the need for maintenance treatment. Long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully on a regular basis. Children with Tourette's disorder (6-18 years): This medicine has been shown to be effective at doses of 2 mg to 20 mg daily in children (6-18 years) with Tourette's disorder. The initial dose is 2 mg daily, with gradual increases in increments of 5mg at intervals of 2 weeks or longer. The dose of this medicine should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with Tourette's disorder. Patients should be periodically reassessed to determine the need for maintenance treatment. Long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully on a regular basis.

This medication can increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses. Therefore, during treatment, the patient's condition should be carefully monitored, and family members or guardians should also closely observe any behavioral changes in the patient. This medication is not approved for the treatment of pediatric depression. Additionally, this medication can rarely cause serious symptoms of neuroleptic malignant syndrome; therefore, if symptoms such as high fever, muscle rigidity, or altered consciousness occur, medical personnel must be notified immediately. Long-term use may lead to irreversible tardive dyskinesia symptoms, so it should only be used for the minimum dosage and duration as directed by a physician. In elderly patients with dementia, this medication may increase the risk of stroke or death, so it is not recommended for dementia patients. Patients with diabetes or those at risk of hyperglycemia should regularly monitor blood sugar levels while taking this medication and consult a healthcare professional immediately if symptoms of hyperglycemia appear. This medication may cause neurological side effects such as orthostatic hypotension, seizures, and drowsiness; therefore, caution is needed when driving or operating machinery. Furthermore, this medication should not be administered to patients with allergic reactions or lactose intolerance. Any unusual symptoms or suspected side effects should be discussed immediately with a physician.

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

Store this medication in a tightly sealed container to prevent exposure to air and moisture. It is recommended to maintain the storage temperature between 1°C and 30°C at room temperature. Proper storage will help ensure the long-term safety and efficacy of the medication.

Appearance

Blue rectangular tablet

Package unit

30 tablets, 100 tablets