Samsun Aripiprazole Tablets 10 mg

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 per day. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance therapy: The efficacy of this medicine as maintenance therapy for schizophrenia was demonstrated in a clinical trial comparing relapse rates with placebo at a dose of 15 mg per day in patients with schizophrenia who had been stabilized on other antipsychotic drugs for at least 3 months. Patients should be reassessed regularly to determine the need for maintenance therapy. Switching from another antipsychotic: When switching from an existing antipsychotic to this medicine, it is generally most appropriate to start this medicine while gradually reducing the dose of the existing medication. The period of overlapping treatment with most antipsychotics should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder - Adults For monotherapy or adjunctive therapy with lithium or valproate, the recommended initial dose is 15 mg once daily, with or without food. The dose may be increased to 30 mg per day based on clinical response. Doses above 30 mg per day 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 with this medicine (as monotherapy at 15 mg or 30 mg per day) for at least 6 weeks. 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 adult patients 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 per day. 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 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). When a concomitant medicine is discontinued, adjust the dose of aripiprazole to the previous dose; however, when a concomitant 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 of Precautions for Use.) Table 1. Dose 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 treatment for major depressive disorder, it should be administered without dose adjustment.

Child dose

Schizophrenia - Adolescents (13-17 years): The recommended dose is 10 mg per day, with or without food. Doses of 10 mg and 30 mg per day have been studied in adolescent patients (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 per day was not more effective than 10 mg per day. 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 regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly. Treatment of manic and mixed episodes associated with bipolar disorder - Children (10-17 years): The recommended dose for monotherapy is 10 mg per day, with or without food. Efficacy has been demonstrated at doses of 10 mg or 30 mg per day in pediatric patients (10-17 years) with bipolar I disorder. The initial dose is 2 mg per day, 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 pediatric patients with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly. Irritability associated with autistic disorder - Children (6-17 years): The efficacy of this medicine has been demonstrated at doses of 5 mg to 15 mg per day in pediatric patients (6-17 years) with autistic disorder. The recommended initial dose is 1mg or 2mg per day, and should be increased to 5 mg per day; if needed, it may then be increased to 10 mg or 15 mg per day. Dose adjustments up to 5 mg per day 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 pediatric patients with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with regard to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be carefully monitored regularly. Tourette's disorder - Children (6-18 years): The efficacy of this medicine has been demonstrated at doses of 2 mg to 20 mg per day in pediatric patients (6-18 years) with Tourette's disorder. The initial dose is 2 mg per day, 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 pediatric patients with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance therapy. Long-term safety has not been established with regard 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 or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; therefore, physicians should carefully evaluate the necessity and risks of treatment. During the first few months of treatment or when adjusting the dosage, the patient's condition should be closely monitored, and family members or caregivers should also watch for changes in the patient's behavior. This medication is not approved for the treatment of pediatric depression, and caution should be exercised when administering it to patients suspected of having bipolar disorder as manic or mixed symptoms may occur. There may be serious side effects such as neuroleptic malignant syndrome during treatment, and if symptoms such as high fever, muscle rigidity, or changes in mental state occur, immediate medical attention should be sought. Long-term use may lead to tardive dyskinesia, which is an irreversible abnormal movement disorder; therefore, it should be administered at the minimum effective dose for the shortest duration, and discontinuation should be considered if symptoms arise. In elderly patients with dementia, there is an increased risk of cerebrovascular accidents such as strokes and increased mortality; hence, this medication is not approved for the treatment of dementia-related psychosis. Patients with diabetes or at risk of hyperglycemia should periodically check their blood sugar levels and consult medical personnel immediately if hyperglycemic symptoms develop. This medication may cause orthostatic hypotension; therefore, caution is advised when used in patients with cardiovascular diseases or those at risk of hypotension. It should be administered carefully to patients with a history of seizures or a high risk of seizures, and due to potential impairment of judgment or motor skills, driving or operating hazardous machinery should be avoided. Special caution is needed for elderly patients at risk of swallowing difficulties or aspiration pneumonia. This medication should not be administered to hypersensitive patients, nor to patients with lactose intolerance. Common side effects that may occur during treatment include nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, drowsiness, fatigue, and weight gain; patients should consult a physician if symptoms are severe. If unusual changes in behavior, worsening depression, or suicidal impulses occur during treatment, medical personnel should be informed immediately.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle