Arabil Tablets 15 mg (Aripiprazole (Micronized))

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 daily. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment: The efficacy of maintenance treatment with this medicine for schizophrenia was demonstrated in a clinical trial assessing relapse at a dose of 15 mg daily versus placebo in patients with schizophrenia who had been stabilized with another antipsychotic for at least 3 months. Patients should be periodically reassessed to determine the need for maintenance treatment. Switching from another antipsychotic When switching from an existing antipsychotic to this medicine, it is most appropriate to initiate this medicine while gradually reducing the dose of the existing product. The period of concomitant use of most antipsychotics should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder Adults The recommended initial dose, as monotherapy or 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 above 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 medicine (as monotherapy at 15 mg or 30 mg daily) for at least 6 weeks. Patients should be periodically reassessed to determine the need for maintenance treatment. 3. Adjunctive treatment of major depressive disorder - Adults The recommended initial dose for adults taking an existing antidepressant is 2~5mg once daily, with or without food. The efficacy of this medicine as an adjunctive treatment for major depressive disorder has been established at doses of 2~15mg daily. This medicine should be gradually increased in increments of 5mg or less, at intervals of at least 1 week. Maintenance treatment: Maintenance treatment as adjunctive therapy for major depressive disorder has not been evaluated. Patients should be periodically reassessed to determine the need for maintenance treatment. 6. Dosage adjustment considering CYP450 interactions Dosage adjustment is recommended for CYP2D6 poor metabolizers and patients taking a CYP3A4 inhibitor, a CYP2D6 inhibitor, or a strong CYP3A4 inducer (see Table 1). If concomitant medication is discontinued, adjust the dose of aripiprazole 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 the “Interactions” section under Precautions for Use.) Table 1. Dosage 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 therapy for major depressive disorder, it should be administered without dose adjustment.

Child dose

1. Schizophrenia Adolescents (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 a further 2 days. Thereafter, the dose was increased in increments of 5 mg. However, a dose of 30 mg daily was not more effective than a dose of 10 mg daily. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be periodically reassessed to determine the need for maintenance treatment. 2. Treatment of manic and mixed episodes associated with bipolar disorder 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 a further 2 days. Thereafter, the dose should be increased in increments of 5 mg. Maintenance treatment has not been evaluated in children with bipolar I disorder. Patients should be periodically reassessed to determine the need for maintenance treatment. 4. Irritability associated with autistic disorder - Children (6-17 years) This medicine has been shown to be effective at doses of 5 mg to 15 mg daily in children (6-17 years) with autistic disorder. The recommended initial dose is 1mg or 2mg daily; increase to 5 mg daily and, if necessary, thereafter 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 medicine should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with autistic disorder. Patients should be periodically reassessed to determine the need for maintenance treatment. 5. Tourette's disorder - Children (6-18 years) This medicine has been shown to be effective 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 increments of 5mg at intervals of 2 weeks or longer. The dose of this medicine should be individualized according to tolerability and response. Maintenance treatment has not been evaluated in children with Tourette's disorder. Patients should be periodically reassessed to determine the need for maintenance treatment.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depression or psychiatric disorders, so the physician must carefully determine the necessity and risks of treatment. Patients of all ages taking this medication should be closely monitored for worsening of symptoms, suicidal tendencies, or unusual behavioral changes during the early stages of treatment. Family members or caregivers should also watch the patient closely. For patients suspected of having bipolar disorder, it is essential to screen for psychiatric and family history before administering this drug, and caution must be taken as manic or mixed episodes may occur during treatment. This medication can cause a serious side effect known as Neuroleptic Malignant Syndrome; if symptoms such as high fever, muscle rigidity, alterations in mental status, or autonomic nervous system dysregulation occur, treatment must be discontinued immediately, and professional care is needed. With prolonged use, irreversible tardive dyskinesia may occur, therefore the lowest effective dose and shortest duration of treatment should be used, and dose adjustments should be considered if symptoms appear. In elderly patients with dementia, this medication can increase the risk of cerebrovascular events such as stroke and death; therefore, it is not recommended for the treatment of dementia. This medication can affect blood sugar control, so patients with diabetes or those at risk for diabetes should regularly monitor blood sugar levels, and if hyperglycemic symptoms occur, testing should be conducted immediately. Due to the risk of venous thromboembolism, thrombotic risk factors should be assessed and preventative measures taken before and during the use of this medication. This medication should not be administered to patients with hypersensitivity to it or genetic issues such as lactose intolerance. Caution should be exercised when prescribing this drug to patients with orthostatic hypotension, a history of seizures, impaired cognition or motor skills, difficulty regulating body temperature, or swallowing difficulties, particularly during the initial stages of treatment and when adjusting doses. Common side effects include drowsiness, dizziness, anxiety, insomnia, restlessness, fatigue, and tremors, therefore caution should be exercised when driving or operating hazardous machinery. During treatment, adverse reactions such as nausea, vomiting, constipation, headache, fatigue, and weight gain may occur, and if the symptoms are severe or persistent, the patient should consult a physician. If adverse reactions occur during treatment, appropriate monitoring and dose adjustments should be made as necessary to ensure safe treatment.

Suicidal thoughts, suicidal behavior, anxiety, restlessness, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, akathisia, hypomania, mania, hyperpyrexia, muscle rigidity, changes in mental state, autonomic nervous instability, increased serum creatine phosphokinase levels, myoglobinuria, acute renal failure, orthostatic hypotension, positional dizziness, syncope, seizures, convulsions, drowsiness, nausea, vomiting, constipation, headache, dizziness, anxiety, restlessness, extrapyramidal disorder, insomnia, tremors, sedation, fatigue, increased appetite, nasopharyngitis, weight gain, blurred vision, hypersalivation, fever, sialorrhea, decreased appetite, apathy, dysmenorrhea, rhinorrhea, rash, hemocytopenia, cardiopulmonary failure, bradycardia, cardiac arrest, atrioventricular block, atrial fibrillation, angina pectoris, palpitations, myocardial infarction, extrasystoles, sinus tachycardia, myocardial ischemia, eyelid edema, photophobia, diplopia, scotoma, gastroesophageal reflux disease, tongue swelling, esophagitis, pancreatitis, myasthenia, peripheral edema, chest pain, facial swelling, vascular edema, hypothermia, hepatitis, jaundice, hypersensitivity, falls, self-harm, heatstroke, increased serum creatine phosphokinase levels, weight loss, elevated liver enzymes, increased blood urea, increased serum bilirubin, increased serum creatinine, prolonged QT on electrocardiogram, elevated serum prolactin, increased blood glucose, elevated serum lactate dehydrogenase, increased glycated hemoglobin, increased GGT, decreased appetite, hyperlipidemia, diabetes, hyperglycemia, hypokalemia, hyponatremia, hypoglycemia, hypersomnia, diabetic ketoacidosis, muscle rigidity, muscle weakness, muscle tension, decreased movement, rhabdomyolysis, coordination abnormality, language disorders, Parkinsonism, cogwheel rigidity, memory disturbance, cerebrovascular accident, decreased physical activity, tardive dyskinesia, hypotonia, hypertonia, akinesia, muscular spasms, decreased movement, generalized tonic-clonic seizure, chorea, suicidal thoughts, aggression, loss of libido, hostility, suicide attempt, increased libido, anger, sexual arousal disorder, delirium, intentional self-harm, suicide, tics, thoughts of murder, anxiety, somnambulism, urinary retention, polyuria, nocturia, erectile dysfunction, amenorrhea, menstrual irregularity, chest pain, gynecomastia, priapism, dyspnea, congestion, aspiration pneumonia, hyperhidrosis, rash, pruritus, photosensitivity reaction, hair loss, urticaria, back pain, epistaxis, dry eye, ejaculation disorder, stuttering, hyperactivity, sleep disorder, palpitations, oculomotor seizures, numbness, abnormal thinking, hallucinations, gastrointestinal dysfunction, sialorrhea, urination disorders, intentional tremor, rigidity, restlessness, psychosis, personality disorder, aggressive response, inappropriate laughter, soliloquy, abnormal muscle tension, erythema, fracture, death, depression

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

Yellow circular tablet

Package unit

30 tablets, 100 tablets