Samsung Aripiprazole Tablet 15 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. When switching from another 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

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. 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. 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. 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.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with depression or psychiatric disorders; thus, the physician must carefully consider the benefits and risks of treatment. After starting treatment, patients and families should closely monitor for suicidal tendencies or behavioral changes and consult medical personnel immediately if unusual symptoms occur. This medication has not been approved for the treatment of pediatric depression, and appropriate testing is necessary for patients suspected of bipolar disorder. Rarely, a serious side effect known as Neuroleptic Malignant Syndrome may occur, thus if high fever, muscle rigidity, or changes in mental status occur, treatment should be discontinued immediately and you should go to a hospital. Long-term use may result in irreversible movement disorders, therefore, the physician should prescribe the lowest effective dose for the shortest duration possible and regularly assess the patient's condition. In elderly patients with dementia, the risk of stroke and death may be increased, therefore the use of this medication is not recommended. Blood glucose levels may rise or diabetes may worsen, so patients with diabetes should regularly check their blood glucose levels, and patients at risk of diabetes should also be cautious. There is a risk of thrombosis, so patients with risk factors for thrombosis should be closely monitored before and during the use of this medication. Patients with allergies to this medication or lactose intolerance should not use it, and those with orthostatic hypotension, a history of seizures, or cognitive impairment should be administered with caution. There is a risk of accidents due to symptoms such as drowsiness when driving or operating dangerous machinery. Various side effects such as weight gain, headache, dizziness, insomnia, anxiety, dyspepsia, muscle cramps, etc. may occur while taking this medication, and if symptoms are severe, you should consult a doctor. If any unusual symptoms or side effects are suspected during the course of treatment, inform medical personnel immediately, and do not arbitrarily change or discontinue the prescribed dose.

• 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 and moisture. The storage temperature should be between 1 and 30 degrees Celsius, which will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle