Aripikojung 5 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 medication 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 treatment: The efficacy of this medication for maintenance treatment of schizophrenia was demonstrated in a clinical trial evaluating relapse versus placebo at a dose of 15 mg once daily in patients with schizophrenia who had been stabilized with another antipsychotic medication for at least 3 months. Patients should be periodically reassessed to determine the need for maintenance treatment. Switching from another antipsychotic medication: When switching from an existing antipsychotic medication to this medication, it is most appropriate to initiate this medication while gradually reducing the dose of the existing medication. The period of overlapping treatment with most antipsychotic medications 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 to 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 were not evaluated in clinical trials. Maintenance treatment: The efficacy of maintenance treatment in bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this medication for at least 6 weeks (15 mg or 30 mg once daily as monotherapy). Patients should be periodically reassessed 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 medication as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg per day. The dose should be gradually increased in increments of no more than 5mg 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 periodically reassessed to determine the need for maintenance treatment. 6. Dose adjustment considering CYP450 interactions Dose adjustment is recommended for patients who are CYP2D6 poor metabolizers and patients taking a CYP3A4 inhibitor, CYP2D6 inhibitor, or strong CYP3A4 inducer (see Table 1). If concomitant medication is discontinued, adjust the aripiprazole dose 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 “Interactions” 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 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 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 once daily, 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 an additional 2 days. Thereafter, the dose was increased in increments of 5 mg. However, 30 mg per day was not more effective than 10 mg per day. 2. 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 an additional 2 days. Thereafter, the dose should be increased in increments of 5 mg. 4. Irritability associated with autistic disorder — Children (6-17 years): This medication has demonstrated efficacy at doses of 5 mg to 15 mg per day in children (6-17 years) with autistic disorder. The recommended initial dose is 1 mg or 2 mg per day, and it should be increased to 5 mg per day, and, if needed, thereafter to 10 mg or 15 mg per day. Dose adjustment up to 5 mg per day should be gradual, with intervals of at least 1 week. The dose of this medication should be individualized according to tolerability and response. 5. Tourette's disorder — Children (6-18 years): This medication has demonstrated efficacy at doses of 2 mg to 20 mg per day in children (6-18 years) with Tourette's disorder. The initial dose is 2 mg per day, with gradual increases in increments of 5 mg at intervals of at least 2 weeks. The dose of this medication should be individualized according to tolerability and response.

This medication may increase the risk of suicidal thoughts or actions in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses, so it must be discussed thoroughly with a physician before use. The patient's condition should be closely monitored at the beginning of treatment, and family members or caregivers should also carefully observe any changes in the patient's behavior. This medication is not approved for the treatment of pediatric depression and should be used cautiously in children. Additionally, although rare, it can cause a serious condition known as neuroleptic malignant syndrome, which can present with symptoms such as high fever, muscle rigidity, and altered mental status; immediate medical attention should be sought if these occur. Long-term use may result in irreversible tardive dyskinesia, and any symptoms should prompt consultation with a doctor. In elderly patients with dementia, there is an increased risk of cerebrovascular accidents such as stroke and mortality associated with this medication, requiring special caution. Diabetic patients should regularly monitor their blood glucose levels as it may affect glucose control, and report any symptoms of hyperglycemia to healthcare professionals immediately. This medication can affect blood circulation and increase the risk of venous thromboembolism, so patients with risk factors for thrombosis must consult a doctor prior to use. Patients with hypersensitivity or genetic issues such as lactose intolerance should not take this medication. Caution is needed for patients with orthostatic hypotension, a history of seizures, and cognitive and motor function impairment, as drowsiness may affect driving or operating machinery. It may affect thermoregulation, requiring caution in high-temperature environments or during vigorous exercise, and patients with dysphagia require special management to reduce the risk of aspiration pneumonia. This medication should not be used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Possible side effects include nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia, drowsiness, fatigue, weight gain, etc. Symptoms should be monitored; if severe or persistent, a doctor should be consulted. Continuous observation is necessary for suicidal tendencies, worsening depression, and abnormal behavioral changes during treatment.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees. Proper storage will help maintain the drug's effectiveness and safety.

Appearance

Blue rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle