Hallym Aripiprazole Tablet 5 mg

Adult dose

Adults with schizophrenia: The recommended initial dose is 10 mg or 15 mg once daily, with or without food. For the treatment of schizophrenia, the dose may be adjusted within the range of 10-30 mg once daily. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment of schizophrenia in adults: The efficacy of this drug as maintenance treatment for schizophrenia 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 regularly reassessed to determine the need for maintenance treatment. Switching from another antipsychotic: When switching from an existing antipsychotic to this drug, it is most appropriate to initiate this drug while gradually reducing the dose of the existing medication. The period of concomitant use of most antipsychotics should be minimized. Treatment of manic and mixed episodes associated with bipolar disorder in adults: The recommended initial dose, as monotherapy or as adjunctive therapy to 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 exceeding 30 mg once daily have not been evaluated in clinical trials. Maintenance treatment of bipolar disorder in adults: The efficacy of maintenance treatment for bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this drug for at least 6 weeks (15 mg or 30 mg once daily as monotherapy). Patients should be regularly reassessed to determine the need for maintenance treatment. Adjunctive treatment of major depressive disorder in adults: The recommended initial dose for adults taking an existing antidepressant is 2~5mg once daily, with or without food. The efficacy of this drug as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg once daily. The dose should be increased gradually in increments of no more than 5mg at intervals of at least 1 week. Maintenance treatment of major depressive disorder in adults: Maintenance treatment as adjunctive therapy for major depressive disorder has not been evaluated. Patients should be regularly reassessed to determine the need for maintenance treatment. 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). When concomitant medication is discontinued, adjust the aripiprazole dose 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 ‘Interactions’ under Precautions for Use.) 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 once daily, with or without food. Doses of 10 mg and 30 mg once 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 5 mg increments. However, a dose of 30 mg once daily was not more effective than 10 mg once daily. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be regularly reassessed to determine the need for maintenance treatment. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, or cognitive and behavioral development; therefore, patients should be carefully monitored regularly. Treatment of manic and mixed episodes associated with bipolar disorder in 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 5 mg increments. Maintenance treatment has not been evaluated in pediatric patients with bipolar I disorder. Patients should be regularly reassessed to determine the need for maintenance treatment. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, or cognitive and behavioral development; therefore, patients should be carefully monitored regularly. Irritability associated with autistic disorder in children (6-17 years): Efficacy 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 1mg or 2mg once daily, increased to 5 mg once daily and, if needed, thereafter 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 should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in pediatric patients with autistic disorder. Patients should be regularly reassessed to determine the need for maintenance treatment. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, or cognitive and behavioral development; therefore, patients should be carefully monitored regularly. Tourette’s disorder in children (6-18 years): Efficacy 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 5 mg increments at intervals of at least 2 weeks. The dose should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in pediatric patients with Tourette’s disorder. Patients should be regularly reassessed to determine the need for maintenance treatment. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, or cognitive and behavioral development; therefore, patients should be carefully monitored regularly.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses. Therefore, the patient's condition should be monitored closely during treatment, and family members or caregivers should carefully observe for any changes. Furthermore, no increased risk of suicide has been reported in adults over 24 years of age, while older adults (over 65 years) show a tendency for reduced risk. Serious side effects such as neuroleptic malignant syndrome may occur when administering this medication; if there are symptoms like high fever, muscle rigidity, or changes in mental state, immediate consultation with medical personnel is necessary. Long-term use may result in irreversible side effects such as tardive dyskinesia, so it is crucial to administer the minimum effective dose for the least amount of time. In elderly patients with dementia, the risk of cerebrovascular accidents, including strokes, may increase, hence it is advisable not to use this medication in dementia patients. Patients with diabetes or those at risk for high blood sugar should regularly monitor their glycemic control, and if hyperglycemic symptoms occur, they should inform their healthcare provider immediately. This medication poses a risk of venous thromboembolism related to issues with blood circulation; therefore, patients with risk factors for thrombosis should exercise caution. Patients with hypersensitivity or lactose intolerance should not take this medication. Care should be taken when used for patients with orthostatic hypotension, history of seizures, or impaired judgment or motor skills, as drowsiness or dizziness may occur; thus, driving or operating dangerous machinery should be avoided. Additionally, there may be impaired thermoregulation, so caution is needed during excessive exercise or exposure to hot environments. During treatment, there is a risk of dysphagia or aspiration pneumonia, necessitating careful observation, especially in the elderly. This medication should not be used for the treatment of ADHD, and patients at risk for suicide should be prescribed the minimum dosage to prevent overdose. Side effects such as nausea, vomiting, constipation, headaches, dizziness, anxiety, insomnia, restlessness, drowsiness, fatigue, increased appetite, nasopharyngitis, weight gain, excessive salivation, tremors, sedation, restlessness, blurred vision, muscle pain, musculoskeletal stiffness, muscle spasm, pain, sore throat, cough, fever, thirst, malaise, decreased appetite, dysmenorrhea, runny nose, rash, hirsutism, dry tongue, tongue spasms, sleep talking, increased insulin levels in the blood, and increased creatine phosphate may occur. If these symptoms are severe or suddenly appear, contact medical staff immediately. There may be weight gain, so it is advisable to regularly check weight changes. Cardiac adverse reactions have also been reported, necessitating close monitoring for patients with heart conditions. This medication can have a wide range of side effects and risks, so it must be taken according to the doctor's instructions and regular check-ups and monitoring are necessary.

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

This medication should be stored in a tightly sealed container to protect it from air or moisture. Moreover, it is best to keep the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold places. This way, the medication's efficacy can be safely maintained.

Appearance

Blue rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle