Aripiprazole 15 mg Tablets (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 medicine may be adjusted within a range of 10-30 mg daily. The dose should not be increased before 2 weeks, which is the time needed to reach steady state. Maintenance treatment: The efficacy of this medicine for maintenance treatment of schizophrenia was demonstrated in a clinical trial assessing relapse versus placebo at a dose of 15 mg daily in patients with schizophrenia who had been stabilized on another antipsychotic for at least 3 months. When switching from another antipsychotic to this medicine, it is generally most appropriate to initiate this medicine while gradually reducing the dose of the existing product. 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 as adjunctive therapy with lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg daily based on clinical response. Doses above 30 mg daily have not been evaluated in clinical trials. Maintenance treatment: The efficacy of this medicine for maintenance treatment of bipolar I disorder was demonstrated in a clinical trial in patients stabilized after receiving this medicine (as monotherapy at 15 mg or 30 mg daily) for at least 6 weeks. 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 medicine as adjunctive treatment of major depressive disorder has been established at doses of 2~15mg daily. This medicine should be titrated gradually in increments of 5mg or less at intervals of at least 1 week. Maintenance treatment: Maintenance treatment as adjunctive therapy for major depressive disorder has not been evaluated. CYP2D6 poor metabolizers: 1/2 the usual dose Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): 1/2 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

Adolescents with schizophrenia (13-17 years): The recommended dose is 10 mg daily, with or without food. Doses of 10 mg and 30 mg daily 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 daily was not more effective than 10 mg daily. Treatment of manic and mixed episodes associated with bipolar disorder in children (10-17 years): The recommended dose as monotherapy is 10 mg daily, with or without food. Efficacy has been demonstrated at doses of 10 mg or 30 mg daily in children (10-17 years) with bipolar I disorder. The initial dose is 2 mg daily, 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. Children with irritability associated with autistic disorder (6-17 years): The efficacy of this medicine has been demonstrated at doses of 5 mg to 15 mg daily in children (6-17 years) with autistic disorder. The recommended initial dose is 1mg or 2mg daily, titrated to 5 mg daily and, if needed, thereafter to 10 mg or 15 mg daily. Dose adjustments up to 5 mg daily should be made gradually at intervals of at least 1 week. Children with Tourette's disorder (6-18 years): The efficacy of this medicine has been demonstrated at doses of 2 mg to 20 mg daily in children (6-18 years) with Tourette's disorder. The initial dose is 2 mg daily, with gradual increases in 5mg increments at intervals of at least 2 weeks.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions. Therefore, when administering it to patients in this age group, physicians should carefully evaluate the risks and benefits. All patients taking this medication across all age groups should be closely monitored for worsening depression, suicidal tendencies, or unusual behavioral changes. Family members or caregivers should also meticulously observe the patient and consult a physician if any abnormal signs occur. This medication is not approved for the treatment of pediatric depression. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, which includes symptoms such as high fever, muscle rigidity, changes in mental status, and autonomic dysregulation. If these symptoms appear, medication should be discontinued immediately, and appropriate treatment and monitoring are necessary. Long-term use of this medication can cause tardive dyskinesia, a form of irreversible movement disorder, particularly in the elderly, increasing the risk. If this symptom occurs, consultation with a physician regarding medication adjustment should be considered. Caution is needed when using this medication in elderly patients with dementia, as it may increase the risk of cerebrovascular accidents, including strokes, and mortality. This medication can elevate blood glucose levels, so patients with diabetes or risk factors for diabetes should regularly check their blood glucose control. If symptoms of hyperglycemia (thirst, polyuria, polyphagia, weakness, etc.) occur, they should be reported to healthcare personnel immediately. The risk of thrombosis may increase while taking this medication, thus patients with risk factors for thrombosis require careful management before and during use. Patients with allergy reactions to this medication or certain genetic conditions, such as lactose intolerance, should not be administer it. Patients with orthostatic hypotension, a history of seizures, impaired judgment, temperature regulation disorders, or dysphagia should use this medication cautiously, especially when driving or operating machinery. Side effects such as drowsiness, dizziness, anxiety, insomnia, tremors, muscle rigidity, nausea, vomiting, constipation, weight gain, and others may occur during treatment. If any abnormal symptoms persist or worsen, consultation with a physician is advised.

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

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This will help to preserve its efficacy for a longer period.

Appearance

Yellow round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle