Aripico Tablets 1 mg (Aripiprazole (unmodified))

Adult dose

1. Schizophrenia 1) 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 once daily. 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 was demonstrated in a clinical trial comparing placebo with a dose of 15 mg once daily in patients with schizophrenia who had been stabilized on another antipsychotic for at least 3 months. Patients should be reassessed regularly to determine the need for maintenance therapy. 3) Switching from another antipsychotic When switching from an existing antipsychotic to this medicine, it is most appropriate to start 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 1) Adults - The recommended initial dose, whether used 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 once daily according to clinical response. Doses greater than 30 mg once daily 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 on this medicine for at least 6 weeks (15 mg or 30 mg once daily as monotherapy). Patients should be reassessed regularly to determine the need for maintenance therapy. 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 for major depressive disorder has been established at doses of 2~15mg once daily. The dose should be gradually increased in increments of 5mg or less, at intervals of at least 1 week. - Maintenance therapy: Maintenance therapy as an adjunctive treatment for major depressive disorder has not been evaluated. Patients should be reassessed regularly to determine the need for maintenance therapy. 6. Dose adjustment for CYP450 interactions - Dose adjustment is recommended for CYP2D6 poor metabolizers and patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or strong CYP3A4 inducers (see Table 1). When a concomitant medicine is discontinued, adjust the aripiprazole dose to the previously administered dose; when a CYP3A4 inducer is discontinued, adjust over 1~2 weeks. Thereafter, the dose may be adjusted according to clinical response. (See the “Interactions” section of Precautions for Use.) Table 1. Dose adjustment for CYP2D6 poor metabolizers and patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers Dose adjustment factor Aripiprazole dose CYP2D6 poor metabolizer 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

2) Adolescents (13-17 years) - The recommended dose is 10 mg once daily, with or without food. Doses of 10 mg and 30 mg once 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 another 2 days. Thereafter, the dose was increased in increments of 5 mg. However, the 30 mg daily dose was not more effective than the 10 mg daily dose. - Maintenance therapy has not been evaluated in adolescents with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly. 2) 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 once daily in children (10-17 years) with bipolar I disorder. The initial dose is 2 mg once 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 therapy has not been evaluated in children with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly. 4. Irritability associated with autistic disorder - Children (6-17 years) - Efficacy of this medicine has been demonstrated at doses of 5 mg to 15 mg once daily in children (6-17 years) with autistic disorder. The recommended initial dose is 1 mg or 2 mg once daily, and should be increased to 5 mg once daily; if needed, it may then be increased to 10 mg or 15 mg once daily. Dose adjustments up to 5 mg once 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 therapy has not been evaluated in children with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly. 5. Tourette's disorder - Children (6-18 years) - Efficacy of this medicine has been demonstrated at doses of 2 mg to 20 mg once daily in children (6-18 years) with Tourette's disorder. The initial dose is 2 mg once daily, with gradual increases in increments of 5mg at intervals of at least 2 weeks. The dose of this medicine should be individualized according to tolerability and response. - Maintenance therapy has not been evaluated in children with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly.

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions; therefore, the physician should carefully assess before prescribing this medication. Additionally, all patients taking this medication should be closely monitored for signs of suicidal tendencies or changes in mental state during the early stages of treatment, and family members or caregivers should also closely observe the patient's condition and consult healthcare professionals immediately if there are any unusual signs. This medication can cause serious side effects known as Neuroleptic Malignant Syndrome, which can present as emergency situations with symptoms such as high fever, muscle rigidity, changes in mental state, unstable blood pressure and pulse. If symptoms are suspected, immediate treatment is required. Long-term use may lead to irreversible abnormal movement symptoms known as tardive dyskinesia; thus, this medication should be used at the minimum effective dose and for the shortest duration, and any symptoms should be discussed with a physician. Elderly patients with dementia may have an increased risk of cerebrovascular events and mortality; therefore, this medication should not be used for the treatment of dementia-related psychiatric conditions, and if prescribed, special caution is required. Patients with diabetes or are at risk of hyperglycemia should regularly check their blood sugar levels while taking this medication and inform healthcare professionals immediately if hyperglycemic symptoms arise. Furthermore, this medication may increase the risk of thrombosis; therefore, patients with risk factors for thrombosis should be monitored closely and receive preventive measures both before and during administration. This medication should not be given to patients with allergic reactions or lactose intolerance, and should be administered with caution to patients with orthostatic hypotension, seizure history, and cognitive or motor function impairments. Drowsiness and dizziness may occur during treatment, so caution is needed when driving or operating dangerous machinery. This medication may commonly cause side effects such as weight gain, gastrointestinal symptoms (nausea, vomiting, constipation), headache, insomnia, anxiety, tremors, muscle rigidity; consult your physician if symptoms are severe.

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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius. This will help to preserve the effectiveness and safety of the medication for a longer period.

Appearance

White oblong tablet

Package unit

30 tablets/bottle, 100 tablets/bottle