Hallym Aripiprazole Tablet 10 mg

Adult dose

1. Schizophrenia Adults The recommended starting 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 daily. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment: The efficacy of this medication for maintenance treatment of schizophrenia was demonstrated in a clinical trial evaluating relapse compared with placebo at a dose of 15 mg daily in patients with schizophrenia who had been stabilized on other antipsychotic medications for at least 3 months. Patients should be reassessed regularly to determine the need for maintenance treatment. Switching from another antipsychotic medication When switching from an existing antipsychotic medication to this medication, it is most appropriate to begin this medication while gradually reducing the dose of the existing medication. The period of overlapping treatment with most antipsychotic medications should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder Adults The recommended starting 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 daily according to clinical response. Doses exceeding 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 medication (15 mg or 30 mg daily as monotherapy) for at least 6 weeks. Patients should be reassessed regularly to determine the need for maintenance treatment. 3. Adjunctive treatment of major depressive disorder - Adults The recommended starting dose for adults taking an existing antidepressant is 2~5mg once daily, with or without food. The efficacy of this medication as adjunctive treatment of major depressive disorder has been established at doses of 2~15mg daily. The dose should be increased gradually in increments of 5mg or less, at intervals of at least 1 week. Maintenance treatment: Maintenance treatment as an adjunct for major depressive disorder has not been evaluated. Patients should be reassessed regularly to determine the need for maintenance treatment. 6. Dose adjustment considering CYP450 interactions Dose adjustment is recommended for patients who are CYP2D6 poor metabolizers and patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or strong CYP3A4 inducers (see Table 1). If concomitant medication is discontinued, adjust the aripiprazole dose to the previously administered dose; when a CYP3A4 inducer is discontinued, adjust the dose over 1~2 weeks. The dose may thereafter be adjusted according to clinical response. (See Precautions, Interactions.) CYP2D6 poor metabolizers: 1/2 the usual dose Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): 1/2 the usual dose Strong CYP3A4 inducers (e.g., carbamazepine, rifampin): twice 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 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 another 2 days. Thereafter, the dose was increased in 5 mg increments. However, a dose of 30 mg daily was not more effective than 10 mg daily. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be reassessed regularly 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 another 2 days. Thereafter, the dose should be increased in 5 mg increments. Maintenance treatment has not been evaluated in children with bipolar I disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Irritability associated with autistic disorder in children (6-17 years) This medication has demonstrated efficacy at doses of 5 mg to 15 mg daily in children (6-17 years) with autistic disorder. The recommended starting dose is 1mg or 2mg daily, and should be increased to 5 mg daily; if necessary, it may then be increased 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 medication should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with autistic disorder. Patients should be reassessed regularly to determine the need for maintenance treatment. Children with Tourette's disorder (6-18 years) This medication has demonstrated efficacy 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 5mg increments at intervals of at least 2 weeks. The dose of this medication should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with Tourette's disorder. Patients should be reassessed regularly to determine the need for maintenance treatment.

This drug carries an increased risk of suicidal thoughts or behavior in children, adolescents, and young adults suffering from major depressive disorder or other psychiatric conditions; therefore, physicians should carefully evaluate the benefits and risks when prescribing. Patients of all ages should be closely monitored for worsening depression, suicidal thoughts, or unusual behavior during the initial treatment and after any dosage changes, and family members or caregivers should also keep a careful watch. This medication is not approved for treating pediatric depression. It may cause a serious side effect known as Neuroleptic Malignant Syndrome, which presents symptoms such as high fever, muscle rigidity, changes in mental state, and autonomic instability. If this syndrome is suspected, administration should be immediately stopped, and the patient requires hospitalization for intensive treatment and monitoring. Long-term use may lead to Tardive Dyskinesia, an irreversible and involuntary movement disorder, so it is crucial to administer the minimum effective dose for the shortest duration possible. Use in elderly patients with dementia may increase the risk of cerebrovascular accidents, including strokes, and mortality, so it should be avoided in these cases. Diabetic patients or those at risk of diabetes should regularly monitor their blood glucose levels during treatment and consult healthcare professionals immediately if symptoms of hyperglycemia occur. This medication may cause orthostatic hypotension, so patients with hypotension or cardiovascular diseases should use it with caution. Those with a history of seizures or at high risk for seizures should also be cautious when using this medication. It may induce drowsiness, dizziness, and impaired judgment, so care should be taken when driving or operating hazardous machinery. Caution is advised when administering this medication to patients at risk of dysphagia or aspiration pneumonia. Symptoms such as anxiety, agitation, aggression, and impulsivity may occur during treatment; if unusual behavior arises, consultation with healthcare professionals is recommended. This medication should not be administered to patients with hypersensitivity or certain genetic lactose intolerance. Common side effects may include weight gain, gastrointestinal symptoms (nausea, vomiting, constipation), headache, insomnia, fatigue, tremors, muscle stiffness, and others. Cardiac abnormalities (increased heart rate, changes in electrocardiogram) or anomalies in blood glucose and liver function tests may also require regular monitoring. If any adverse reactions occur during treatment, patients should consult their physician immediately for appropriate intervention.

• Suicidal thoughts
• suicidal behavior
• anxiety
• restlessness
• panic attacks
• insomnia
• hypersensitivity
• hostility
• aggression
• impulsiveness

This medication may be sensitive to air or moisture and should be stored in a tightly closed container. It is advisable to maintain storage at room temperature between 1 to 30 degrees Celsius to preserve potency.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle