Aripiprazole 2 mg (Aripiprazole (unclassified))

Adult dose

1. Schizophrenia 1) 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 once daily. The dose should not be increased before 2 weeks, which is the time required to reach steady state. - Maintenance therapy: The efficacy of maintenance therapy with this medicine for schizophrenia was established in a clinical trial evaluating 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 regularly to determine the need for maintenance therapy. 3) Switching from another antipsychotic When switching from an existing antipsychotic to this medicine, it is most appropriate to begin treatment with this medicine while gradually reducing the dose of the existing medicine. The period of concomitant use of most antipsychotics should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder 1) 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 once daily based on clinical response. Doses exceeding 30 mg once daily were not evaluated in clinical trials. - Maintenance therapy: The efficacy of maintenance therapy in bipolar I disorder was established in a clinical trial in patients stabilized with this medicine for at least 6 weeks (as monotherapy at 15 mg or 30 mg once daily). Patients should be reassessed regularly to determine the need for maintenance therapy. 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 medicine as adjunctive treatment for major depressive disorder has been established at 2~15mg once daily. The dose of this medicine should be increased gradually, in increments of no more than 5mg at intervals of at least 1 week. - Maintenance therapy: 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. 6. Dosage adjustments for 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). When concomitant medication is discontinued, adjust the aripiprazole dose to the dose used before concomitant treatment; when discontinuing a concomitant CYP3A4 inducer, adjust over 1~2 weeks. The dose may then be adjusted according to clinical response. (See the “Interactions” section of Precautions for Use.) Table 1. Dosage adjustments 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 of the usual dose Strong CYP2D6 inhibitor (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin) 1/2 of 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 dose adjustment.

Child dose

1. Schizophrenia 2) Adolescents (13-17 years) - The recommended dose is 10 mg once daily, with or without food. Doses of 10 mg and 30 mg once daily 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. Subsequent increases were made in 5 mg increments. However, a dose of 30 mg once daily was not more effective than 10 mg once daily. - Maintenance therapy has not been evaluated in adolescent patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 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 and regularly. 2. Treatment of manic and mixed episodes associated with bipolar disorder 2) Children (10-17 years) - The recommended dose as monotherapy is 10 mg once daily, with or without food. Efficacy has been established at doses of 10 mg or 30 mg once daily in pediatric patients (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. Subsequent increases should be made in 5 mg increments. - Maintenance therapy has not been evaluated in pediatric patients with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. 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 and regularly. 4. Irritability associated with autistic disorder - Children (6-17 years) - Efficacy of this medicine has been established at doses of 5 mg to 15 mg once daily in pediatric patients (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 medicine should be individualized according to tolerability and response. - Maintenance therapy has not been evaluated in pediatric patients with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. 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 and regularly. 5. Tourette’s disorder - Children (6-18 years) - Efficacy of this medicine has been established at doses of 2 mg to 20 mg once daily in pediatric patients (6-18 years) with Tourette’s disorder. The initial dose is 2 mg once daily, with gradual increases in 5 mg increments at intervals of at least 2 weeks. The dose of this medicine should be individualized according to tolerability and response. - Maintenance therapy has not been evaluated in pediatric patients with Tourette’s disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. 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 and regularly.

This medication may increase the risk of suicidal thoughts or behaviors when administered to children or young adults with depression or psychiatric disorders; therefore, healthcare providers should carefully consider this and patients and guardians should be monitored closely. This drug may cause a rare but fatal side effect known as Neuroleptic Malignant Syndrome; if symptoms such as high fever, muscle rigidity, or changes in mental status occur, healthcare providers should be notified immediately. Long-term use may lead to irreversible extrapyramidal symptoms, so it is advisable to use the lowest possible dose and duration and to consult healthcare providers if symptoms occur. In elderly patients with dementia, administering this drug may increase the risk of stroke or death, so caution should be exercised or the drug should be avoided in such cases. Patients with diabetes or those at risk for hyperglycemia should manage their blood sugar well, as this medication may elevate blood glucose levels; they should be alert for symptoms of high blood sugar. This medication may increase the risk of thromboembolism; therefore, patients with risk factors for thromboembolism should be monitored carefully before and during treatment. Administration is contraindicated in patients with hypersensitivity or specific genetic lactose intolerance. This drug may cause orthostatic hypotension; therefore, patients with unstable blood pressure or cardiovascular disorders should use it cautiously. Patients with a history of seizures or at high risk for seizures need to be careful when taking this drug. Drowsiness or cognitive impairment may occur, so it is advisable to avoid driving or operating dangerous machinery while taking this medication. The ability to regulate body temperature may be diminished; thus, caution should be taken to avoid excessive exercise or exposure to high-temperature environments. Patients with swallowing difficulties may be at risk for aspiration pneumonia and should use this medication cautiously. Patients should be closely monitored for any changes in mental symptoms such as worsening depression, suicidal impulses, anxiety, restlessness, and aggression during treatment, and if adverse signs occur, they should consult a physician immediately. Pediatrics and adolescents may experience higher rates of adverse reactions; therefore, careful observation is required during treatment. During this medication, side effects such as nausea, vomiting, constipation, headache, dizziness, insomnia, fatigue, changes in appetite, and weight gain may occur, and patients should inform healthcare providers of any symptoms that arise. Symptoms of movement disorders such as akathisia, tremors, and extrapyramidal symptoms may appear, necessitating careful observation. This medication should be started at the minimum dose and adjusted gradually, with regular assessments of the patient's condition during long-term use. If the side effects or changes in symptoms are severe or persistent, consideration should be given to discontinuing the drug or adjusting the dose.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is advisable to store the medication at room temperature, neither too hot nor too cold, preferably between 1 to 30 degrees Celsius.

Appearance

Green oval tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle