Beabilly Tablet 15mg (Aripiprazole (Micronized))

Adult dose

1. Schizophrenia 1) Adults - The recommended initial 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 per day. The dose should not be increased before 2 weeks, the time required to reach steady state. - Maintenance therapy: The efficacy of this drug as maintenance therapy for schizophrenia was demonstrated in a clinical trial evaluating relapse versus placebo at a dose of 15 mg per day in patients with schizophrenia who had been stabilized on another antipsychotic for at least 3 months. Patients should be reassessed periodically to determine the need for maintenance therapy. 3) Switching from another antipsychotic When switching from an existing antipsychotic to this drug, it is most appropriate to initiate this drug while gradually reducing the dose of the existing agent. The period of overlap with most antipsychotics should be minimized. ２. Treatment of manic and mixed episodes associated with bipolar disorder 1) Adults - The recommended initial dose, as monotherapy or adjunctive therapy with lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased to 30 mg per day based on clinical response. Doses exceeding 30 mg per day have not been evaluated in clinical trials. - Maintenance therapy: The efficacy of maintenance therapy for bipolar I disorder was demonstrated in a clinical trial in patients stabilized on this drug (as monotherapy at 15 mg or 30 mg per day) for at least 6 weeks. Patients should be reassessed periodically to determine the need for maintenance therapy. 4. 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). If concomitant medication is discontinued, adjust the dose of aripiprazole to the previously administered dose; however, when discontinuing a concomitant CYP3A4 inducer, 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. Dose adjustment for CYP2D6 poor metabolizers and patients taking a CYP2D6 inhibitor, CYP3A4 inhibitor, or CYP3A4 inducer Dose adjustment factor Aripiprazole dose CYP2D6 poor metabolizer 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 2) Adolescents (13-17 years) - The recommended dose is 10 mg once daily, with or without food. Doses of 10 mg and 30 mg per day were 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 a dose of 10 mg per day. - Maintenance therapy has not been evaluated in adolescents with schizophrenia. Patients should be reassessed periodically to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored regularly and carefully. ２. Treatment of manic and mixed episodes associated with bipolar disorder 2) Children (10-17 years) - The recommended dose as monotherapy is 10 mg once daily, with or without food. Efficacy has been demonstrated at doses of 10 mg or 30 mg per day in children (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 periodically to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored regularly and carefully. 3. Tourette’s disorder - Children (6-18 years) - Efficacy 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, followed by gradual increases in increments of 5 mg at intervals of at least 2 weeks. The dose of this drug 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 periodically to determine the need for maintenance therapy. Long-term safety has not been established with respect to the emergence of suicidal symptoms, growth, maturation, and cognitive and behavioral development; therefore, patients should be monitored regularly and carefully.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorders or other psychiatric disorders, so the physician should carefully evaluate the patient's condition before using this medication. After starting treatment, the patient's condition should be closely monitored, and family members or caregivers should also be vigilant for any abnormal behaviors such as suicidal tendencies or worsening depression. This medication can cause a serious side effect known as Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle rigidity, altered consciousness, or irregular heartbeat occur, medical personnel should be notified immediately. Prolonged use may lead to irreversible abnormal movement symptoms known as tardive dyskinesia, so consultation with a doctor should be sought if symptoms arise. In elderly patients with dementia, there may be increased risk of cerebrovascular accidents such as stroke; therefore, this medication is not used in patients with dementia-related mental disorders. This medication may raise blood glucose levels, so patients with diabetes or those at risk for diabetes should regularly monitor and manage their blood sugar levels. There is a risk of venous thromboembolism; thus, careful observation and preventive measures are needed for patients with risk factors for thrombosis, both before and during use of this medication. This medication is not administered to patients with hypersensitivity to it or lactose intolerance. Patients with orthostatic hypotension, seizure history, cognitive impairment, temperature regulation disorders, and dysphagia should use this medication cautiously, and care should be taken during driving or operating hazardous machinery. While taking this medication, various side effects such as nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia, drowsiness, fatigue, appetite changes may occur, so if abnormal symptoms persist, medical personnel should be consulted. Particularly at the beginning of treatment or during dosage changes, the risk of side effects is higher, so careful monitoring is required.

Suicidal thoughts, suicidal behavior, anxiety, restlessness, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, akathisia, hypomania, mania, hyperthermia, rigidity, changes in mental status, irregular pulse, blood pressure fluctuations, tachycardia, sweating, arrhythmia, increased serum creatine phosphokinase levels, myoglobinuria, acute renal failure, tardive dyskinesia, stroke, transient ischemic attack, drowsiness, somnolence, incontinence, excessive salivation, dizziness, hyperglycemia, ketoacidosis, hyperosmolar coma, venous thromboembolism, pruritus, urticaria, orthostatic hypotension, position-related dizziness, syncope, seizures, convulsions, cognitive impairment, thought disorders, impaired motor skills, increased appetite, nausea, vomiting, constipation, headache, fatigue, decreased appetite, pharyngitis, weight gain, extrapyramidal disorders, tremors, sedation, agitation, fidgeting, sore throat, cough, pain, limb pain, musculoskeletal stiffness, myalgia, muscle cramps, blurred vision, attention disorders, upper respiratory tract infection, arthralgia, muscular tension disorders, dyskinesia, hypersomnia, dysmenorrhea, rhinorrhea, rash, asthenia, peripheral edema, chest pain, facial edema, angioedema, hypothermia, hepatitis, jaundice, hypersensitivity, falls, self-harm, heat stroke, increased serum creatine phosphokinase levels, weight loss, increased liver enzymes, elevated blood urea, increased bilirubin levels, elevated serum creatinine, QT prolongation on ECG, elevated serum prolactin, increased blood sugar, increased lactate dehydrogenase, increased hemoglobin A1c, elevated GGT, anorexia, hyperlipidemia, diabetes mellitus, hypokalemia, hyponatremia, hypoglycemia, polyuria, diabetic ketoacidosis, rigidity, muscle weakness, muscle tension, decreased movement, coordination disorders, speech disorders, Parkinsonism, cogwheel rigidity, memory disorders, cerebrovascular accident, reduced physical activity, tardive dyskinesia, hypotonia, hypertonia, akinesia, myoclonic jerks, increased frequency of movements, suicidal thoughts, aggression, loss of libido, hostility, suicide attempts, increased libido, anger, sexual arousal disorder, delirium, deliberate self-harm, suicide, tics, thoughts of murder, tension, sleepwalking, urinary retention, polyuria, nocturia, erectile dysfunction, amenorrhea, menstrual irregularity, chest pain, gynecomastia, priapism, dyspnea, congestion, aspiration pneumonia, hyperhidrosis, rash, pruritus, phototoxic reactions, alopecia, urticaria, dry tongue, tongue spasms, sleep talking, hirsutism, increased serum insulin, decreased serum prolactin, hiccups, eosinophilia, systemic drug reactions, restless legs syndrome, blood sugar fluctuations, pathological gambling, hypersexuality, anaphylactic reactions, angioedema, laryngeal spasms, oropharyngeal spasms, stuttering, hyperactivity, sleep disorders, palpitations, ocular myoclonus, numbness, abnormal sensations, hallucinations, dyspepsia, drooling, urination disorders, intentional tremors, agitation, psychosis, personality disorders, aggressive responses, inappropriate laughter, talking to oneself, rigidity, fractures, death, depression

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance

Yellow round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle