Aripiprazole 10 mg (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, 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. 1. Schizophrenia - 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 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. Treatment of manic and mixed episodes associated with 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. 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 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 medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depression or psychiatric disorders; therefore, careful consideration should be given by the prescribing physician before use. During treatment with this medication, patients and caregivers should closely monitor for worsening depression, suicidal risk, or unusual changes in behavior. For patients suspected of having bipolar disorder, appropriate tests to assess the risk of bipolar disorder should be conducted before the administration of this medication, as it may induce mania or mixed episodes. This medication can cause a severe side effect known as neuroleptic malignant syndrome; therefore, if symptoms such as high fever, muscle rigidity, or changes in mental state occur, immediate medical attention should be sought. Long-term use may lead to irreversible tardive dyskinesia, so it should be used at the lowest effective dose for the shortest duration, with regular monitoring of the patient's condition. Elderly patients with dementia may have an increased risk of cerebrovascular accidents, such as strokes; thus, the use of this medication is not recommended. Patients with diabetes or at risk of hyperglycemia should frequently check their blood sugar levels while taking this medication and consult a healthcare professional immediately if symptoms of hyperglycemia occur. This medication may increase the risk of thromboembolism; therefore, patients with risk factors for thrombosis should consult with their healthcare provider before use and take appropriate preventive measures. Patients with allergic reactions to this medication or experiencing genetic issues such as lactose intolerance should not use it. Orthostatic hypotension may occur, so blood pressure changes should be monitored, and if dizziness or fainting symptoms arise, immediate healthcare assistance should be sought. Patients with a history of seizures or at high risk for seizures should be closely monitored for the possibility of seizure occurrence during use. This medication may cause drowsiness or cognitive impairment, so caution should be exercised when driving or operating dangerous machinery. There may be decreased ability to regulate body temperature; thus, caution is advised during excessive exercise or exposure to hot environments. Patients with dysphagia are at risk for aspiration pneumonia, so extra caution is needed when using this medication. When prescribing this medication to patients with inherent suicidal risks, thorough monitoring and the use of the minimum effective dose is required. Common side effects include nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, drowsiness, fatigue, weight gain, extrapyramidal symptoms, etc. If adverse reactions occur, symptomatic consultation with a physician may be necessary to adjust or discontinue medication. Weight changes, blood sugar changes, irregular heartbeats, and blood pressure changes may occur during drug therapy, so regular checkups are recommended. This medication is also used in children and adolescents, but particular attention must be paid to observing for adverse reactions and effectiveness. If severe abnormal symptoms or side effects occur, inform healthcare professionals immediately to receive appropriate interventions.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle