Aripiprazole Tablet 10 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, the dose of this medicine may be adjusted within a range of 10-30 mg daily. The dose should not be increased before 2 weeks, which is the time needed to reach steady state. Maintenance treatment: The efficacy of this medicine for maintenance treatment of schizophrenia was demonstrated in a clinical trial assessing relapse versus placebo at a dose of 15 mg daily in patients with schizophrenia who had been stabilized on another antipsychotic for at least 3 months. Patients should be reassessed periodically to determine the need for maintenance treatment. Switching from another antipsychotic: When switching from an existing antipsychotic to this medicine, it is generally most appropriate to initiate this medicine while gradually reducing the dose of the existing product. The period of overlap with most antipsychotics 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 with lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg daily based on clinical response. Doses above 30 mg daily have not been evaluated in clinical trials. Maintenance treatment: The efficacy of this medicine for maintenance treatment of bipolar I disorder was demonstrated in a clinical trial in patients stabilized after receiving this medicine (as monotherapy at 15 mg or 30 mg daily) for at least 6 weeks. Patients should be reassessed periodically to determine the need for maintenance treatment. 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 of major depressive disorder has been established at doses of 2~15mg daily. This medicine should be titrated gradually 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 reassessed periodically to determine the need for maintenance treatment. 6. Dose adjustment considering CYP450 interactions Dose 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; if 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.) Table 1. Dose adjustment in CYP2D6 poor metabolizers and patients taking a CYP2D6 inhibitor, CYP3A4 inhibitor, or CYP3A4 inducer CYP2D6 poor metabolizers: 1/2 the usual dose Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): 1/2 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

1. Schizophrenia — Adolescents (13-17 years): The recommended dose is 10 mg daily, with or without food. Doses of 10 mg and 30 mg daily have been 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 another 2 days. Thereafter, the dose was increased in increments of 5 mg. However, a dose of 30 mg daily was not more effective than 10 mg daily. 2. Treatment of manic and mixed episodes associated with bipolar disorder — 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 another 2 days. Thereafter, the dose should be increased in increments of 5 mg. 4. 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 daily in children (6-17 years) with autistic disorder. The recommended initial dose is 1mg or 2mg daily, titrated to 5 mg daily and, if needed, 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. 5. Tourette's disorder — Children (6-18 years): The efficacy of this medicine has been demonstrated 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 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 behavior in children, adolescents, and young adults with major depressive disorder or psychiatric conditions. Therefore, during the treatment with this medication, the patient's condition should be closely monitored, and family members or caregivers should be vigilant for any unusual behaviors in the patient and consult a doctor if necessary. This medication can rarely cause a severe side effect known as neuroleptic malignant syndrome, characterized by high fever, muscle rigidity, changes in consciousness, and irregular heartbeat. If these symptoms occur, immediate treatment is necessary. Long-term use may lead to irreversible extrapyramidal symptoms, and if symptoms develop, the patient should consult a doctor for possible medication adjustment. Elderly patients with dementia are at increased risk for serious vascular issues such as stroke, hence the use of this medication is not recommended. Blood sugar levels may increase or diabetes symptoms may worsen, so diabetic patients should regularly check their blood glucose levels. This medication may affect blood circulation and increase the risk of thrombosis, hence caution is advised in patients with risk factors for thrombosis. Patients with known allergic reactions to this medication or lactose intolerance should not take it. Patients with orthostatic hypotension or a history of seizures should be careful while driving or operating hazardous machinery, as judgment or motor skills may be impaired. Severe drowsiness or difficulty swallowing may occur, especially in elderly patients who should be cautious of falls or aspiration pneumonia. Possible side effects during treatment include nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia, restlessness, drowsiness, fatigue, changes in appetite, and weight gain. If any unusual symptoms are severe or suddenly appear, the patient should immediately consult a doctor to evaluate whether to adjust or discontinue the medication.

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, to maintain the effectiveness of the medication, it is important to store it at a temperature between 1 and 30 degrees Celsius.

Appearance

Pink, rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle