Aripiprazole 5 mg Tablets

Adult dose

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 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 therapy for schizophrenia with this medicine was demonstrated in a clinical trial assessing relapse versus placebo at a dose of 15 mg once daily in patients with schizophrenia who had been stabilized with another antipsychotic 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 to this medicine, it is most appropriate to initiate this medicine while gradually reducing the dose of the existing product. The period of overlap of most antipsychotics 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 based on clinical response. Doses exceeding 30 mg per day have not been evaluated in clinical trials. Maintenance therapy: The efficacy of maintenance therapy in bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this medicine (as monotherapy at 15 mg or 30 mg once daily) for at least 6 weeks. Patients should be reassessed regularly to determine the need for maintenance therapy. 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 2~15mg per day. The dose should be increased gradually in increments of no more than 5mg at intervals of at least 1 week. Maintenance therapy: Maintenance therapy for adjunctive treatment of major depressive disorder has not been evaluated. Patients should be reassessed regularly to determine the need for maintenance therapy. CYP2D6 poor metabolizers: 1/2 the usual dose Potent CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) or potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): 1/2 the usual dose Potent CYP3A4 inducers (e.g., carbamazepine, rifampin): twice 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. If concomitant medications are discontinued, adjust the dose of aripiprazole to the previous dose; when discontinuing concomitant use of a CYP3A4 inducer, adjust the dose over 1~2 weeks. Thereafter, the dose may be adjusted according to clinical response.

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 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 5 mg increments. However, a dose of 30 mg per day was not more effective than a dose of 10 mg per day. Treatment of manic and mixed episodes associated with bipolar disorder, pediatric patients (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 pediatric patients (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 5 mg increments. Irritability associated with autistic disorder, pediatric patients (6-17 years): The efficacy of this medicine has been demonstrated at doses of 5 mg to 15 mg per day in pediatric patients (6-17 years) with autistic disorder. The recommended initial dose is 1mg or 2mg per day, and should be increased to 5 mg per day; if needed, it may then be increased 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 medicine should be individualized according to tolerability and response. Tourette's disorder, pediatric patients (6-18 years): The efficacy of this medicine 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, and the dose should be gradually increased in 5 mg 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 depression or psychiatric disorders; thus, a doctor should carefully consider use and patients or guardians must observe closely. This medication may cause a serious side effect known as neuroleptic malignant syndrome; if symptoms such as high fever, muscle rigidity, changes in mental state, or autonomic nervous system disturbances occur, inform medical personnel immediately. Long-term use may result in irreversible extrapyramidal symptoms, so it should be administered in the minimum effective dose for the shortest duration, and consult the doctor at the onset of any symptoms. In elderly patients with dementia, this medication may increase the risk of stroke or death; therefore, it is not approved for treating dementia-related psychosis and requires special caution. Side effects such as increased blood sugar have been reported; diabetic patients should regularly monitor their blood sugar control and consult medical personnel immediately if symptoms of hyperglycemia occur. This medication may increase the risk of thrombosis; thus, patients with risk factors for thrombosis should consult with a doctor before use and take appropriate preventive measures. Patients with hypersensitivity to this medication or genetic issues such as lactose intolerance should not use it. Patients with orthostatic hypotension, history of seizures, cognitive and motor function impairments must use this medication with extra caution; they should avoid driving or operating dangerous machinery if symptoms such as drowsiness or dizziness occur. Ability to regulate body temperature may be impaired, so caution is needed in situations of excessive exercise or exposure to high temperatures. Elderly patients at risk for dysphagia or aspiration pneumonia must be especially cautious when using this medication. During treatment, closely monitor for worsening depressive symptoms, suicidal impulses, anxiety, agitation, or aggressive behavior; if any abnormal symptoms occur, consult a doctor immediately. Common side effects during treatment may include nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, drowsiness, fatigue, appetite changes, and weight gain, so please be aware. Extrapyramidal symptoms, muscle tension abnormalities, tremors, or akathisia may occur, and if such symptoms arise, inform medical personnel immediately and receive appropriate measures. This medication can also be used in children and adolescents, but due to varying side effect rates by age, it should be taken according to a doctor's instructions. In case of overdose, visit the hospital immediately for appropriate treatment, and do not discontinue this medication arbitrarily; always follow a doctor's instructions for use.

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

Store this medication in a tightly sealed container to prevent exposure to air or moisture; it is safe to store at room temperature between 1 and 30 degrees Celsius. Storing this way helps maintain the medication's effectiveness for a longer time.

Appearance

Blue rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle