Aripiprazole Tablets 10mg (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 the range of 10-30 mg daily. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment: The efficacy of maintenance treatment with this medicine for schizophrenia was demonstrated in a clinical trial assessing relapse at a dose of 15 mg daily versus placebo in patients with schizophrenia who had been stabilized with another antipsychotic for at least 3 months. Patients should be periodically reassessed to determine the need for maintenance treatment. 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 concomitant use of most antipsychotics should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder Adults The recommended initial dose, as monotherapy or adjunctive therapy to lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg daily according to clinical response. Doses above 30 mg daily have not been 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 medicine (as monotherapy at 15 mg or 30 mg daily) for at least 6 weeks. 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 medicine as an adjunctive treatment for major depressive disorder has been established at doses of 2~15mg daily. This medicine should be gradually increased 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 periodically reassessed to determine the need for maintenance treatment. 6. Dosage adjustment considering CYP450 interactions Dosage 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; when 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. Dosage 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

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 were 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 a further 2 days. Thereafter, the dose was increased in increments of 5 mg. However, a dose of 30 mg daily was not more effective than a dose of 10 mg daily. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be periodically reassessed to determine the need for maintenance treatment. 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 a further 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 periodically reassessed to determine the need for maintenance treatment. Irritability associated with autistic disorder in children (6-17 years): This medicine has been shown to be effective 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; increase to 5 mg daily and, if necessary, 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 periodically reassessed to determine the need for maintenance treatment. Children with Tourette's disorder (6-18 years): This medicine has been shown to be effective 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 increments of 5mg at intervals of 2 weeks or longer. 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 periodically reassessed to determine the need for maintenance treatment.

This medication may increase the risk of suicidal thoughts or actions in children, adolescents, and young adults with major depressive disorder or psychiatric conditions. Therefore, patients taking this medication should be closely monitored for suicidal tendencies or behavioral changes, especially during the initial months. Family members or guardians should also carefully observe the patient's condition and immediately inform healthcare professionals of any unusual signs. This medication should be administered with caution in patients suspected of having bipolar disorder, as it may exacerbate symptoms of bipolar disorder. Additionally, it can cause serious side effects known as neuroleptic malignant syndrome, which can include severe muscle rigidity, high fever, and changes in mental status. Immediate medical attention is necessary if these symptoms occur. Long-term use can lead to irreversible tardive dyskinesia, so it should be used at the minimum effective dose and for the shortest duration, with ongoing monitoring of the patient's condition. In elderly patients with dementia, there is an increased risk of cerebrovascular events such as stroke and increased mortality, and this medication is not recommended for treating dementia-related psychiatric disorders. Diabetic patients with poorly controlled blood sugar levels should frequently check their blood glucose status while taking this medication, and should consult healthcare professionals if symptoms of hyperglycemia occur. This medication may increase the risk of thrombosis due to blood circulation problems, so careful management is needed in patients with thrombosis risk factors both before and during treatment. It should be used cautiously in patients with orthostatic hypotension, a history of seizures, or impaired judgment or motor skills, and they should be careful when driving or operating dangerous machinery. Common side effects may include drowsiness, dizziness, anxiety, insomnia, tremors, vomiting, constipation, among others; if these symptoms are severe, healthcare professionals should be consulted. Additionally, during treatment with this medication, weight gain, blood glucose changes, and heart rhythm abnormalities may occur, so regular monitoring is necessary. This medication contains lactose; therefore, it should not be taken by patients with lactose intolerance, and administration should be avoided in individuals with hypersensitivity. Finally, this medication is not approved for the treatment of depression in children and adolescents, so special caution is required in this age group.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at a temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer duration.

Appearance

Pink oblong tablet

Package unit

30 tablets, 100 tablets