Aripiprazole 15 mg (Aripiprazole (Micronized))

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, this medicine may be adjusted within a dose range of 10-30 mg per day. The dose should not be increased before 2 weeks have elapsed, as this is the time required to reach steady state. - Maintenance treatment: The efficacy of maintenance treatment for schizophrenia with this medicine was demonstrated in a clinical trial comparing relapse rates with placebo at a dose of 15 mg per day in patients with schizophrenia who had been stabilized on another antipsychotic medication for at least 3 months. Patients should be reassessed regularly to determine whether maintenance treatment is needed. Switching from another antipsychotic medication When switching from an existing antipsychotic medication to this medicine, it is most appropriate to start this medicine while gradually reducing the dose of the existing medication. The period of overlap between most antipsychotic medications should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder Adults - For monotherapy or adjunctive therapy with lithium or valproate, the recommended initial dose is 15 mg once daily, with or without food. 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 for bipolar I disorder was demonstrated in a clinical trial in patients stabilized after receiving this medicine (as monotherapy at 15 mg or 30 mg per day) for at least 6 weeks. Patients should be reassessed regularly to determine whether maintenance treatment is needed. 3. 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 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 regularly to determine whether maintenance treatment is needed. 6. Dose adjustments considering CYP450 interactions - Dose adjustment is recommended for patients who are CYP2D6 poor metabolizers and patients taking a CYP3A4 inhibitor, a CYP2D6 inhibitor, or a strong CYP3A4 inducer (see Table 1). If a concomitant medication is discontinued, adjust the dose of aripiprazole to the previously administered dose; if 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. Dose adjustment for CYP2D6 poor metabolizers and patients taking a CYP2D6 inhibitor, CYP3A4 inhibitor, or CYP3A4 inducer Dose adjustment factor / Aripiprazole dose CYP2D6 poor metabolizer / 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 treatment 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 patients (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 5 mg increments. However, a dose of 30 mg per day was not more effective than a dose of 10 mg per day. Bipolar disorder, children (10-17 years): - The recommended dose for 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 pediatric patients (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 a further 2 days. Thereafter, the dose should be increased in 5 mg increments. 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 per day; increase to 5 mg per day and, if necessary, thereafter 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. 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, and the dose is gradually increased in 5mg increments at intervals of at least 2 weeks. The dose of this medicine should be individualized according to tolerability and response.

This drug is primarily used for the treatment of psychiatric disorders, particularly effective in depression, schizophrenia, and bipolar disorder. However, there may be an increased risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so close monitoring of symptoms deterioration or abnormal behavior changes is required during the initial treatment. Family members or guardians should also carefully observe the patient and immediately consult medical staff if any unusual symptoms occur. This medication is not approved for the treatment of pediatric depression. A serious side effect, Neuroleptic Malignant Syndrome, which can be fatal, may occur; therefore, if symptoms such as high fever, muscle rigidity, changes in mental status, or autonomic instability appear, medical staff should be informed immediately. If this syndrome is suspected, the administration of the drug should be stopped and appropriate treatment should be sought. Tardive Dyskinesia, which is an irreversible extrapyramidal syndrome, may occur with long-term use, especially in elderly patients. This medication should be used at the minimum effective dose for the shortest duration possible, and if symptoms occur, adjustments in medication should be considered in consultation with the healthcare provider. In patients with dementia, there is an increased risk of cerebrovascular accidents, such as stroke, and higher mortality; therefore, this medication is not recommended for patients with dementia-related psychiatric disorders. When administered to elderly patients, particular care should be taken for fall risk, drowsiness, and swallowing difficulties. This medication may raise blood sugar levels; hence, diabetic patients should regularly check their blood glucose control status, and patients with risk factors for diabetes should also be monitored closely from the beginning. The risk of venous thromboembolism is also present, so patients with thrombotic risk factors should be observed closely before and during administration. Patients with allergic reactions or genetic issues such as lactose intolerance should not use this medication. Patients with orthostatic hypotension, a history of seizures, or cognitive and motor function impairment should be administered with caution, as this medication may cause drowsiness or dizziness, necessitating caution while driving or operating machinery. Antipsychotics can reduce the ability to regulate body temperature, so excessive heat exposure or dehydration should be avoided. During treatment, common side effects such as nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, drowsiness, fatigue, weight gain, and hypersalivation may occur. If any abnormal motor symptoms or mental changes such as suicidal thoughts occur during the treatment, immediate consultation with a healthcare professional is essential. This medication must be taken exactly as prescribed by a physician, and it is crucial to report any side effects or unusual symptoms to a professional immediately.

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

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1°C to 30°C at room temperature.

Appearance

Yellow round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle