Hanmira Aripiprazole Tablet 15mg

Adult dose

Adults with schizophrenia: 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. 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. 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. 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. 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. 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. 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.

This drug may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses. Therefore, the risks and benefits must be carefully assessed when administering this drug or other antidepressants, and patients and families should be closely monitored for suicidal tendencies or changes in behavior. While taking this medication, severe side effects such as Neuroleptic Malignant Syndrome may occur, so caution must be taken for high fever, muscle rigidity, changes in mental status, and autonomic dysfunction symptoms. If these symptoms appear, immediate notification to healthcare professionals is required, and treatment should be stopped, with appropriate symptomatic treatment potentially necessary. This medication carries a risk of irreversible tardive dyskinesia with long-term use; thus, it should be used at the minimum effective dose and for the shortest duration possible. Caution is particularly warranted in the elderly and women due to a higher risk of occurrence. Using this medication in elderly patients with dementia may increase the risk of cerebrovascular accidents such as strokes and death; thus, this drug is not recommended for dementia patients. This medication may increase the risk of hyperglycemia and diabetes; hence, patients with diabetes or risk factors must manage their blood sugar carefully and consult healthcare providers immediately if symptoms of hyperglycemia occur. Due to the risk of venous thromboembolism, it is important to identify risk factors for thrombosis and take preventive measures while taking this medication. This drug should not be administered to patients with hypersensitivity or lactose intolerance, and should be used cautiously in patients with orthostatic hypotension, seizure history, and cognitive and motor disturbances. Symptoms such as drowsiness, dizziness, insomnia, and anxiety may occur while taking this medication; hence, caution should be taken with driving or operating hazardous machinery. Common side effects during the use of this medication may include weight gain, nausea, vomiting, headache, tremors, akathisia, insomnia, and atypical symptoms; if abnormal symptoms occur, consult with healthcare professionals. Especially in children and adolescents, the incidence of adverse reactions is higher, necessitating careful monitoring of those taking this medication.

Suicidal thoughts, suicidal behavior, anxiety, restlessness, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, akathisia, hypomania, mania, hyperthermia, muscle rigidity, change in mental status, irregular pulse, blood pressure changes, tachycardia, sweating, deep vein thrombosis, increased serum creatine phosphokinase levels, myoglobinuria, acute renal failure, tardive dyskinesia, stroke, transient ischemic attack, somnolence, drowsiness, incontinence, excessive salivation, dizziness, hyperglycemia, ketoacidosis, hyperosmolar coma, venous thromboembolism, itching, urticaria, hypersensitivity reaction, orthostatic hypotension, positional dizziness, syncope, seizures, convulsions, drowsiness, nausea, vomiting, constipation, headache, akathisia, anxiety, insomnia, restlessness, extrapyramidal disorder, fatigue, increased appetite, nasopharyngitis, weight gain, sedation, tremors, blurred vision, hypersalivation, fever, sialorrhea, malaise, dysmenorrhea, runny nose, rash, hypoplastic anemia, cardiopulmonary failure, bradycardia, cardiac arrest, atrioventricular block, atrial fibrillation, angina, palpitations, myocardial infarction, ectopic beats, sinus tachycardia, myocardial ischemia, eyelid edema, photophobia, diplopia, scotoma, gastroesophageal reflux disease, tongue edema, esophagitis, pancreatitis, weakness, peripheral edema, chest pain, facial swelling, vascular edema, hypothermia, hepatitis, jaundice, allergic reaction, blood glucose fluctuations, pathological gambling, hypersexuality, hiccups, eosinophilia, systemic symptoms, restless legs syndrome, decreased serum prolactin, restlessness, psychosis, personality disorders, aggressive reactions, inappropriate laughter, soliloquy, stuttering, muscle tension disorders, erythema, fractures, death, hyperactivity, sleep disorders, ocular motor seizures, abnormal perceptions, numbness, intention tremor, hallucinations, gastrointestinal dysfunction, urination disorders, loss of appetite, hyperlipidemia, diabetes, hypokalemia, hyponatremia, hypoglycemia, diabetic ketoacidosis, muscle rigidity, muscle weakness, muscle tone, reduced movement, coordination disorders, speech disorders, Parkinsonism, cogwheel rigidity, memory disturbances, cerebrovascular accident, reduction in exercise, tardive dyskinesia, hypotonia, hypertonia, akinesia, myoclonus, excessive movement, suicidal thoughts, aggression, loss of libido, hostility, suicide attempts, increased libido, anger, sexual arousal disorder, delirium, deliberate self-harm, suicide, tics, thoughts of homicide, tension disorder, somnambulism, urinary retention, polyuria, nocturia, erectile dysfunction, amenorrhea, menstrual irregularities, chest pain, gynecomastia, priapism, dyspnea, congestion, aspiration pneumonia, hyperhidrosis, rash, itching, photosensitivity reaction, hair loss, urticaria, back pain, epistaxis, dry eye, ejaculation disorders

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius to preserve the efficacy of the medication for an extended period.

Appearance

Yellow round tablet

Package unit

30 tablets/bottle, 100 tablets/bottle