Boryung Aripiprazole Tablet 15 mg

Adult dose

Adults with schizophrenia: 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 maintenance treatment for schizophrenia was established 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 the need for maintenance therapy. Switching from another antipsychotic: When switching from an existing antipsychotic medication to this medication, it is most appropriate to start this medication while gradually reducing the dose of the existing medication. The period of overlap with most antipsychotic medications should be minimized. 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 according to 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 established in a clinical trial in patients stabilized with this medication for at least 6 weeks (as monotherapy at 15 mg or 30 mg per day). Patients should be reassessed regularly to determine the need for maintenance therapy. Adjunctive treatment for 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 medication as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg per day. The dose should be increased gradually in increments of 5mg or less, at intervals of at least 1 week. Maintenance therapy: Maintenance therapy as an adjunctive treatment for major depressive disorder has not been evaluated. Patients should be reassessed regularly to determine the need for maintenance therapy. Dose adjustment is recommended for CYP2D6 poor metabolizers and patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or strong CYP3A4 inducers (see Table 1). When concomitant medication is discontinued, adjust the aripiprazole dose to the previously administered dose; when discontinuing a concomitant CYP3A4 inducer, adjust the dose over 1~2 weeks. Thereafter, the dose may be adjusted according to clinical response (see ‘Drug interactions’ in Precautions for use). Table 1. Dose adjustment for CYP2D6 poor metabolizers and patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers CYP2D6 poor metabolizers: 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

Adolescents with schizophrenia (13-17 years): The recommended dose is 10 mg per day, with or without food. Doses of 10 mg and 30 mg per day 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 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 regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. Treatment of manic and mixed episodes associated with bipolar disorder, children (10-17 years): The recommended dose as monotherapy is 10 mg per day, 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 children with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. Irritability associated with autistic disorder, children (6-17 years): Efficacy has been demonstrated in children (6-17 years) with autistic disorder at doses of 5 mg to 15 mg per day. The recommended initial dose is 1mg or 2mg per day, increased 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 medication should be individualized according to tolerability and response. Maintenance therapy has not been evaluated in children with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly. Tourette's disorder, children (6-18 years): Efficacy has been demonstrated in children (6-18 years) with Tourette's disorder at doses of 2 mg to 20 mg per day. The initial dose is 2 mg per day, with gradual increases in increments of 5mg at intervals of at least 2 weeks. The dose of this medication should be individualized according to tolerability and response. Maintenance therapy has not been evaluated in children with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Since long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be monitored carefully and regularly.

This medication may increase the risk of suicidal thoughts or behaviors in children or adolescents with major depressive disorder or psychiatric disorders. Therefore, the patient's condition should be carefully monitored during the use of this drug, and family members or caregivers should also closely observe any changes in the patient's behavior. Additionally, this drug can cause a serious side effect known as neuroleptic malignant syndrome, which presents with symptoms such as high fever, muscle rigidity, alteration in mental status, and irregular pulse. If these symptoms occur, immediate medical attention is required, and treatment should be discontinued with appropriate measures taken. The risk of tardive dyskinesia, an irreversible movement disorder, may develop with long-term use of this medication, so it should be used at the minimum effective dose and duration. When administered to elderly patients with dementia, there is an increased risk of cerebrovascular events such as stroke and death, requiring special caution. Furthermore, this medication can elevate blood sugar levels, so diabetic patients or those with risk factors should regularly check their blood glucose control. The risk of thrombosis may also increase during the use of this drug, so patients with risk factors for thrombosis should be cautious. Allergic reactions may occur, so patients with hypersensitivity should not take this medication, and lactose-intolerant patients should also be careful. Symptoms like orthostatic hypotension, seizures, cognitive and motor function impairment, temperature regulation issues, and difficulty swallowing may arise during treatment, so consult a physician if these symptoms occur. This drug may cause drowsiness, insomnia, anxiety, tremors, headache, dyspepsia, and various side effects, so if abnormal symptoms persist or worsen, inform medical personnel. Finally, this drug should be administered with caution in patients at risk of suicide, and it is crucial to continuously monitor the patient's condition during treatment.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius (room temperature) to preserve the drug's efficacy and safety.

Appearance

Yellow round tablet

Package unit

30 tablets/bottle, 100 tablets/bottle