Beavilil 5 mg Tablets (Aripiprazole (Microcrystalline))

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 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. 3) 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 acute manic and mixed episodes associated with bipolar disorder 1) 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 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 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 acute 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 behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions, necessitating close monitoring of the patient and caregiver at the start of treatment. This drug can cause a rare side effect known as neuroleptic malignant syndrome, characterized by symptoms such as high fever, muscle rigidity, altered consciousness, irregular heart rate, and blood pressure; immediate medical attention is required if any abnormal symptoms occur. Long-term use may lead to tardive dyskinesia, an irreversible movement disorder, therefore it should be used at the minimum effective dosage and duration, and consultation with a healthcare provider is necessary if symptoms arise. In dementia patients, there may be an increased risk of serious cerebrovascular accidents such as strokes; therefore, this drug should not be used in patients with dementia-related psychosis. This medication may raise blood sugar levels; patients with diabetes should regularly monitor their blood sugar levels, and those at risk for diabetes should be closely observed. There is a risk of venous thromboembolism; patients with thrombotic risk factors should evaluate and take preventive measures before and during the use of this drug. Allergic reactions may occur, so patients with hypersensitivity should not take this medication, and those with lactose intolerance should also refrain from using it. Patients with orthostatic hypotension, a history of seizures, or impaired cognitive or motor abilities should exercise caution when using this medication, as symptoms such as drowsiness or dizziness may occur, which could impair driving or operation of hazardous machinery. Temperature regulation ability may be decreased, so caution should be exercised during vigorous exercise or exposure to high temperature environments, and patients with swallowing difficulties are particularly at risk for aspiration pneumonia. Common side effects that may occur during treatment include anxiety, insomnia, restlessness, tremors, headache, nausea, vomiting, constipation, weight gain, and may require consultation with medical staff if these symptoms arise. Particular attention should be given to the risk of suicide or changes in mental state during early treatment or changes in dosage; patients and their families should be educated to recognize and report such changes promptly.

• Suicidal thoughts
• suicidal behavior
• anxiety
• nervousness
• panic attacks
• insomnia
• irritability
• hostility
• aggression
• impulsiveness

This medication should be stored in a sealed container to prevent air and moisture from entering, and should be kept at room temperature between 1 to 30 degrees Celsius. This helps maintain the efficacy of the medication for a longer time.

Appearance

Blue rectangular tablets

Package unit

30 tablets/bottle, 100 tablets/bottle