Hallym Aripiprazole 1 mg Tablet

Adult dose

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 drug may be adjusted within the range of 10-30 mg once daily. The dose should not be increased before 2 weeks, the time required to reach steady state. Maintenance treatment: The efficacy of this drug for maintenance treatment of schizophrenia was demonstrated in a clinical trial assessing relapse compared with placebo at a dose of 15 mg once daily in patients with schizophrenia who had been stabilized with other antipsychotic drugs for at least 3 months. Patients should be reevaluated regularly to determine the need for maintenance treatment. Switching from another antipsychotic: When switching from an existing antipsychotic drug to this drug, it is most appropriate to initiate this drug while gradually reducing the dose of the existing drug. The period of overlap between antipsychotic drugs should be minimized in most cases. Treatment of manic and mixed episodes associated with bipolar disorder Adults: The recommended initial 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 once daily according to clinical response. Doses above 30 mg once daily have not been evaluated in clinical trials. Maintenance treatment: The efficacy of maintenance treatment for bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this drug for at least 6 weeks (15 mg or 30 mg once daily as monotherapy). Patients should be reevaluated regularly to determine the need for maintenance treatment. 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 drug as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg once daily. The dose 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 reevaluated regularly to determine the need for maintenance treatment. Dosage adjustment considering CYP450 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): 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

Schizophrenia — Adolescents (13-17 years): The recommended dose is 10 mg once daily, with or without food. Doses of 10 mg and 30 mg once daily have been studied in adolescent patients (13-17 years). In these studies, 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 once daily was not more effective than a dose of 10 mg once daily. Treatment of manic and mixed episodes associated with bipolar disorder — 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 once daily in children (10-17 years) with bipolar I disorder. The initial dose is 2 mg once 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 — Children (6-17 years): This drug has demonstrated efficacy at doses of 5 mg to 15 mg once daily in children (6-17 years) with autistic disorder. The recommended initial dose is 1 mg or 2 mg once daily, and the dose should be increased to 5 mg once daily and, if needed, thereafter to 10 mg or 15 mg once daily. Dose adjustments up to 5 mg once daily should be made gradually at intervals of at least 1 week. The dose of this drug should be individualized according to tolerability and response. Tourette's disorder — Children (6-18 years): This drug has demonstrated efficacy at doses of 2 mg to 20 mg once daily in children (6-18 years) with Tourette's disorder. The initial dose is 2 mg once daily, and the dose should be gradually increased in 5mg increments at intervals of at least 2 weeks. The dose of this drug 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 major depression or other psychiatric disorders. Therefore, when prescribing to patients in this age group, the physician should carefully evaluate the need for treatment and the risks involved. Close monitoring for suicidal tendencies or changes in behavior is essential during the initial months of treatment or when adjusting the dosage. Family members or caregivers should also closely monitor the patient's condition and consult a doctor immediately if any abnormal signs are observed. This medication is not approved for the treatment of pediatric depression and therefore should not be used in this population. This medication can cause a rare but life-threatening condition known as Neuroleptic Malignant Syndrome; immediate medical attention is required if symptoms such as high fever, muscle rigidity, or altered mental state occur. It can lead to tardive dyskinesia, which is an irreversible movement disorder, so periodic checks for symptoms are necessary, especially in older adults and females who are at higher risk. Administration to elderly patients with dementia can increase the risk of cerebrovascular accidents (such as stroke) and mortality; therefore, this medication should not be used in this patient group. It may affect blood sugar control, and diabetic patients or those with risk factors for diabetes should regularly monitor their blood sugar levels and report any abnormal symptoms to a physician promptly. There is a risk of venous thromboembolism during treatment with this medication, so patients with thromboembolic risk factors should take preventive measures. This medication should not be administered to patients with hypersensitivity or hereditary lactose intolerance. Caution is advised when administering to patients with orthostatic hypotension, a history of seizures, cognitive impairment, or motor skills decline, as drowsiness or dizziness may occur. There may be a decreased ability to regulate body temperature, so excessive exercise or exposure to high-temperature environments should be avoided. Special attention is needed for patients with dysphagia or those at high risk for aspiration pneumonia. Since patients with mental disorders inherently have a risk of suicide, high-risk patients should be administered the minimum effective dose under close supervision. Common side effects during treatment may include nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, fatigue, drowsiness, changes in appetite, weight gain, extrapyramidal symptoms, etc. When side effects occur, closely observe the severity and changes in symptoms, and consult with healthcare professionals as necessary. Regular health check-ups are necessary as there may be weight gain or cardiac adverse reactions with prolonged use.

Suicidal thoughts, suicidal behavior, anxiety, restlessness, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, hyperthermia, muscle rigidity, changes in mental state, irregular pulse, abnormal blood pressure, tachycardia, sweating, arrhythmia, increased serum creatine phosphokinase, myoglobinuria, acute renal failure, tardive dyskinesia, stroke, transient ischemic attack, somnolence, drowsiness, incontinence, excessive salivation, dizziness, hyperglycemia, ketoacidosis, hyperosmolar coma, venous thromboembolism, itching, urticaria, orthostatic hypotension, positional dizziness, fainting, seizures, convulsions, impaired judgment, thought disorder, impairment of motor skills, drowsiness, dysphagia, insomnia, constipation, headache, nausea, vomiting, increased appetite, nasopharyngitis, weight gain, extrapyramidal disorder, fatigue, sedation, tremor, restlessness, anxiety, sore throat, cough, pain, limb pain, muscular rigidity, myalgia, muscle spasms, blurred vision, attention disorder, upper respiratory infection, arthralgia, myalgia, hypersalivation, fever, salivation, decreased appetite, dysmenorrhea, rhinorrhea, rash, weakness, peripheral edema, chest pain, facial edema, vascular edema, hypothermia, hepatitis, jaundice, hypersensitivity, falls, self-harm, heatstroke, increased serum creatine phosphokinase, weight loss, increased liver enzymes, increased blood urea, increased serum bilirubin, increased serum creatinine, prolonged QT interval on electrocardiogram, increased serum prolactin, increased blood glucose, increased serum lactate dehydrogenase, increased glycosylated hemoglobin, increased GGT, decreased appetite, hyperlipidemia, diabetes mellitus, hypokalemia, hyponatremia, hypoglycemia, thirst, diabetic ketoacidosis, muscle rigidity, muscle weakness, muscle tension, reduced movement, rhabdomyolysis, coordination disorders, speech disorders, Parkinsonism, cogwheel rigidity, memory disturbances, cerebrovascular accident, reduced exercise capability, tardive dyskinesia, decreased muscle tone, increased muscle tone, akinesia, metabolic syndrome, hypomotility, grand mal seizure, chorea, suicidal thoughts, aggressiveness, 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, irregular menstruation, chest pain, gynecomastia, priapism, dyspnea, congestion, aspiration pneumonia, hyperhidrosis, rash, itching, photosensitivity reaction, hair loss, urticaria, back pain, epistaxis, dry eyes, ejaculation disorders, stuttering, hyperactivity, sleep disorders, palpitations, ocular motor seizures, numbness, abnormal thoughts, hallucinations, dyspepsia, hypersalivation, urinary disorders, intentional tremor

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White oblong tablet

Package unit

30 tablets/bottle, 100 tablets/bottle