Beavil 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 may be adjusted within the range of 10-30 mg per day. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance therapy: The efficacy of this drug as maintenance therapy for schizophrenia was demonstrated in a clinical trial evaluating relapse versus placebo at a dose of 15 mg per day 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 therapy. Switching from another antipsychotic: When switching from an existing antipsychotic to this drug, it is most appropriate to initiate this drug while gradually reducing the dose of the existing agent. 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 adjunctive therapy with lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg per day based on clinical response. Doses exceeding 30 mg per day have not been evaluated in clinical trials. Maintenance therapy: The efficacy of maintenance therapy for bipolar I disorder was demonstrated in a clinical trial in patients stabilized on this drug (as monotherapy at 15 mg or 30 mg per day) for at least 6 weeks. Patients should be reassessed periodically to determine the need for maintenance therapy. 4. 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 previously administered dose; however, when discontinuing a concomitant CYP3A4 inducer, 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 therapy 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 another 2 days. Thereafter, the dose was increased in increments of 5 mg. However, a dose of 30 mg per day was not more effective than a dose of 10 mg per day. Maintenance therapy has not been evaluated in adolescents with schizophrenia. Patients should be reassessed periodically to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored regularly and carefully. Treatment of manic and mixed episodes associated with bipolar disorder—Children (10-17 years): The recommended dose as 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 children (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 another 2 days. Thereafter, the dose should be increased in increments of 5 mg. Maintenance therapy has not been evaluated in pediatric patients with bipolar I disorder. Patients should be reassessed periodically to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored regularly and carefully. Tourette’s disorder—Children (6-18 years): Efficacy 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, followed by gradual increases in increments of 5 mg at intervals of at least 2 weeks. The dose of this drug 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 periodically to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored regularly and carefully.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with depression or other psychiatric disorders, so it is important to discuss with a doctor before administration and to closely monitor the patient's condition during treatment. This medication can cause a rare but serious side effect called neuroleptic malignant syndrome, so if symptoms such as high fever, muscle rigidity, or changes in consciousness occur, immediate medical attention should be sought. Long-term use may result in irreversible tardive dyskinesia, which occurs more frequently in the elderly, thus it's important to use the minimal effective dose for the shortest duration possible. In elderly patients with dementia, there is an increased risk of serious cerebrovascular events such as stroke, so it is recommended not to use it in such cases. This medication may elevate blood sugar levels, so diabetic patients should regularly monitor and manage their blood glucose, and patients at risk for diabetes should also be cautious. There is a risk of thrombosis, as this medication can lead to the formation of vascular thrombi known as venous thromboembolism, so it is essential to assess the risk and take preventive measures for patients with risk factors for thrombosis before administration. It should not be administered to patients with hypersensitivity to this medication or lactose intolerance. Caution should be exercised when administering to patients with orthostatic hypotension, history of seizures, cognitive and motor function impairment, temperature regulation issues, or dysphagia, and continuous monitoring is needed during administration. During treatment with this medication, drowsiness, dizziness, insomnia, anxiety, akathisia, and extrapyramidal symptoms may occur, so care should be taken when driving or operating hazardous machinery. Weight gain, gastrointestinal symptoms (nausea, vomiting, constipation), headache, and fatigue may frequently occur; if these symptoms persist or worsen, consulting with a healthcare professional is recommended. There may be occurrences of suicidal thoughts or behaviors, worsening depression, and changes in abnormal behavior during treatment, so it is crucial for patients and caregivers to closely monitor these changes and immediately inform the doctor.

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

This medication should be stored in a tightly closed container to prevent air or moisture exposure, ideally at room temperature between 1 and 30 degrees Celsius. This helps maintain the efficacy and safety of the medication.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle