Aripiprazole 5 mg Tablet (Aripiprazole (Unrefined))

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. Patients should be reassessed periodically to determine the need for maintenance treatment. Switching from another antipsychotic When switching from an existing 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 acute 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. Patients should be reassessed periodically 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 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. Patients should be reassessed periodically to determine the need for maintenance treatment. 6. 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 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 the Interactions section under Precautions for Use.) Table 1. Dose adjustment in CYP2D6 poor metabolizers and patients taking a CYP2D6 inhibitor, CYP3A4 inhibitor, or CYP3A4 inducer 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. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be reassessed periodically to determine the need for maintenance treatment. Long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, cognitive development, or behavioral development; therefore, patients should be monitored carefully and regularly. Children with bipolar disorder (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. Maintenance treatment has not been evaluated in children with bipolar I disorder. Patients should be reassessed periodically to determine the need for maintenance treatment. Long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, cognitive development, or behavioral development; therefore, patients should be monitored carefully and regularly. 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. The dose of this medicine should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with autistic disorder. Patients should be reassessed periodically to determine the need for maintenance treatment. Long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, cognitive development, or behavioral development; therefore, patients should be monitored carefully and regularly. 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. The dose of this medicine should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with Tourette's disorder. Patients should be reassessed periodically to determine the need for maintenance treatment. Long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, cognitive development, or behavioral development; therefore, patients should be monitored carefully and regularly.

This drug should be used with caution in children, adolescents, and young adults with depression or psychiatric disorders, as there may be an increased risk of suicidal thoughts or behaviors. While taking this drug, patients should be closely monitored for changes in mental state, suicidal tendencies, or abnormal behavioral changes, and family members or caregivers should also observe the patient carefully. Serious side effects, known as Neuroleptic Malignant Syndrome, may occur. If high fever, muscle rigidity, mental changes, or autonomic instability symptoms appear, immediate medical attention should be sought. Long-term use may result in irreversible abnormal movement symptoms; therefore, it should be administered at the minimum effective dose and duration, with regular monitoring for symptoms. In elderly patients with dementia, there is an increased risk of serious cerebrovascular accidents such as stroke, so this medication should be used with great caution. This drug may affect blood sugar control; therefore, diabetic patients or individuals at risk should regularly check their blood sugar and closely monitor for abnormal symptoms. There is a risk of thrombosis; patients with risk factors for thrombosis should assess the risks and take preventive measures before using this medication. Orthostatic hypotension, dizziness, and fainting risks exist, so care should be taken when getting up slowly from sitting or lying down. Patients with a history of seizures or high seizure risk should be particularly cautious while taking this medication. This drug may cause drowsiness or impaired judgment, so caution is advised when driving or operating dangerous machinery. There is a risk of swallowing difficulties or aspiration pneumonia, so special care should be taken with the elderly or patients with compromised swallowing functions. This drug should not be administered to patients with hypersensitivity or lactose intolerance. Common adverse reactions during administration may include nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia, drowsiness, fatigue, weight gain, extrapyramidal symptoms, etc. If severe adverse symptoms or new symptoms arise, immediate consultation with a physician is necessary. This drug requires special caution when used in children and adolescents, and changes in weight or behavior should be closely monitored. Adherence to prescribed dosage and duration is essential, and caution is needed to avoid discontinuation or dosage increases without consultation.

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

This drug should be stored in a sealed container to protect it from air and moisture. It should also be kept away from extremely hot or cold environments and ideally stored at normal room temperatures between 1 degree and 30 degrees.

Appearance

Blue rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle