Aripiprazole 5 mg (Aripiprazole (Unrefined))

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 of this drug may be adjusted within the range of 10-30 mg/day. The dose should not be increased before 2 weeks, which is the time required to reach steady state. Maintenance treatment: The efficacy of this drug for maintenance treatment of schizophrenia was established in a clinical trial evaluating relapse compared with placebo at a dose of 15 mg/day in patients with schizophrenia who had been stabilized with other antipsychotic drugs for at least 3 months. Patients should be reassessed regularly to determine the need for maintenance treatment. Switching from another antipsychotic: When switching from an existing antipsychotic drug to this drug, it is most appropriate to start this drug while gradually reducing the dose of the existing drug. The period of overlap between most antipsychotic drugs 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, with or without food. The dose may be increased to 30 mg/day according to clinical response. Doses exceeding 30 mg/day have not been evaluated in clinical trials. Maintenance treatment: The efficacy of maintenance treatment in bipolar I disorder was established in a clinical trial in patients stabilized with this drug (15 mg or 30 mg/day as monotherapy) 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 existing 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 2~15mg/day. This drug should be gradually increased in increments of 5mg or less at intervals of at least 1 week. Maintenance treatment: Maintenance treatment for adjunctive therapy of major depressive disorder has not been evaluated. Patients should be reassessed regularly 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). If concomitant medication is discontinued, adjust the aripiprazole dose to the previously administered dose; however, when a concomitant 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.) Table 1. Dosage adjustment for CYP2D6 poor metabolizers and patients taking a CYP2D6 inhibitor, CYP3A4 inhibitor, or CYP3A4 inducer Dosage adjustment factor / Aripiprazole dose CYP2D6 poor metabolizer / 1/2 times the usual dose Strong CYP2D6 inhibitor (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin) / 1/2 times the usual dose Strong CYP3A4 inducer (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 dosage adjustment.

Child dose

Adolescents with schizophrenia (13-17 years): The recommended dose is 10 mg once daily, with or without food. Doses of 10 mg and 30 mg once daily were studied in patients with schizophrenia aged 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 daily dose of 30 mg was not more effective than a daily dose of 10 mg. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. Long-term safety has not been established with respect to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully and regularly.\nTreatment of manic and mixed episodes associated with bipolar disorder in children (10-17 years): As monotherapy, the recommended dose is 10 mg once daily, with or without food. Efficacy has been demonstrated at doses of 10 mg or 30 mg once daily in pediatric patients aged 10-17 years with bipolar I disorder. The initial dose is 2 mg once daily, 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 treatment has not been evaluated in pediatric patients with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Long-term safety has not been established with respect to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully and regularly.\nIrritability associated with autistic disorder in children (6-17 years): This medication has demonstrated efficacy at doses of 5 mg to 15 mg once daily in pediatric patients aged 6-17 years with autistic disorder. The recommended initial dose is 1 mg or 2 mg once daily, and the dose should be increased to 5 mg once daily; if needed, it may then be increased to 10 mg or 15 mg once daily. Dose adjustments up to 5 mg once daily 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 treatment has not been evaluated in pediatric patients with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Long-term safety has not been established with respect to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully and regularly.\nTourette's disorder in children (6-18 years): This medication has demonstrated efficacy at doses of 2 mg to 20 mg once daily in pediatric patients aged 6-18 years with Tourette's disorder. The initial dose is 2 mg once daily, 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 treatment has not been evaluated in pediatric patients with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Long-term safety has not been established with respect to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored carefully and regularly.

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depression or other psychiatric disorders. Therefore, clinicians should carefully assess the clinical necessity and risks when prescribing this medication. Patients taking this medication must be closely monitored for the worsening of their condition, suicidal tendencies, or abnormal behavioral changes, and family members or guardians should also monitor the patient's status closely and consult a physician immediately if abnormalities occur. Before administering this medication to patients suspected of having bipolar disorder, appropriate screening tests to assess the risk of bipolar disorder should be performed, and caution is advised as mixed episodes or manic symptoms may occur during treatment. Though rare, this medication may cause a serious side effect known as Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle rigidity, altered mental status, or autonomic nervous system abnormalities occur, treatment should be stopped immediately and medical attention should be sought. Prolonged use may result in tardive dyskinesia, which is an irreversible abnormal movement disorder, so it should be used at the lowest possible dose and for the shortest duration, and consultation with a physician should occur if symptoms arise. In elderly patients with dementia, the use of this medication may increase the risk of death and vascular adverse reactions such as stroke, therefore it is not recommended for dementia patients. During treatment, blood sugar may increase or diabetes may worsen, so patients with diabetes or risk factors should regularly monitor blood sugar and be attentive to symptoms. There is a risk of venous thromboembolism, so thrombotic risk factors should be assessed before and during treatment with this medication, and necessary preventive measures should be taken. This medication should not be administered to patients with hypersensitivity or lactose intolerance, and caution is advised for patients with hereditary lactose-related conditions. Patients at risk of orthostatic hypotension, seizure history, cognitive and motor function impairment, temperature regulation issues, and dysphagia should be administered this medication carefully, especially during the initial treatment and when adjusting the dose, and side effects should be closely monitored. Patients taking this medication may experience various side effects such as drowsiness, dizziness, insomnia, anxiety, agitation, extrapyramidal symptoms, etc., and caution is needed when driving or operating dangerous machinery. Common adverse reactions during treatment include nausea, vomiting, constipation, headache, dizziness, fatigue, weight gain, and these should be discussed with a physician if they are severe or persistent. This medication may induce suicidal thoughts or actions in patients with psychiatric disorders that inherently carry a risk of suicide, therefore patients should be closely monitored during treatment. Metabolic and cardiovascular changes such as weight gain and increased heart rate may occur, making regular health check-ups necessary.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1°C and 30°C to preserve the drug's effectiveness and safety.

Appearance

Blue, rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle