Aripiprazole Calming 1 mg (Aripiprazole (Unmodified))

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 medicine 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 therapy: The efficacy of maintenance therapy with this medicine for schizophrenia was demonstrated in a clinical trial evaluating relapse at a dose of 15 mg once daily versus placebo in patients with schizophrenia who had been stabilized with another antipsychotic for at least 3 months. Patients should be reevaluated regularly to determine the need for maintenance therapy. 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 drug. The period of overlap between most antipsychotics should be minimized. Treatment of manic and mixed episodes associated with bipolar disorder - Adults The recommended initial dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 15 mg once daily, with or without food. The dose may be increased up to 30 mg once daily according to clinical response. Doses greater than 30 mg once daily have not been evaluated in clinical trials. Maintenance therapy: The efficacy of maintenance therapy in bipolar I disorder was demonstrated in a clinical trial in patients stabilized with this medicine 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 therapy. Adjunctive treatment of major depressive disorder - Adults The recommended initial dose for adults taking an antidepressant is 2~5mg once daily, with or without food. The efficacy of this medicine as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg once daily. The dose should be increased gradually in increments of 5mg or less at intervals of at least 1 week. Maintenance therapy: Maintenance therapy for adjunctive treatment of major depressive disorder has not been evaluated. Patients should be reevaluated regularly to determine the need for maintenance therapy. 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 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 once daily was not more effective than a dose of 10 mg once daily. Treatment of manic and mixed episodes associated with bipolar disorder - Pediatric patients (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 pediatric patients (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 increments of 5 mg. Irritability associated with autistic disorder - Pediatric patients (6-17 years) The efficacy of this medicine has been demonstrated at doses of 5 mg to 15 mg once daily in pediatric patients (6-17 years) with autistic disorder. The recommended initial dose is 1 mg or 2 mg once daily, increased to 5 mg once daily and, if needed, then increased 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 medicine should be individualized according to tolerability and response. Tourette's disorder - Pediatric patients (6-18 years) The efficacy of this medicine has been demonstrated at doses of 2 mg to 20 mg once daily in pediatric patients (6-18 years) with Tourette's disorder. The initial dose is 2 mg once daily, gradually increased in increments of 5 mg at intervals of at least 2 weeks. The dose of this medicine 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 depressive disorder or other psychiatric disorders. Therefore, clinicians should carefully assess the risks and benefits before prescribing this medication to patients in this age range. Furthermore, all patients taking this medication should be closely monitored for suicidal tendencies or behavioral changes at the start of treatment and during any dosage changes. Family members or caregivers should also be vigilant in observing the patient's condition, and should consult healthcare professionals immediately if any unusual signs are noticed. This medication is not approved for the treatment of depressive disorders in children, and appropriate diagnosis and screening are necessary before use in suspected bipolar disorder patients. Serious side effects known as neuroleptic malignant syndrome may occur while taking this medication, so if symptoms such as high fever, muscle rigidity, altered consciousness, or autonomic nervous system disturbances arise, immediate treatment is required. Prolonged use may lead to tardive dyskinesia, an irreversible abnormal movement syndrome, hence patients on long-term treatment should be administered the lowest effective dose and monitored regularly for symptoms. In elderly patients with dementia-related psychiatric disorders, there may be an increased risk of stroke and cerebrovascular accidents, or death while using this medication. Therefore, its use is not approved for this population and caution is necessary. This medication may elevate blood glucose levels; thus, patients with diabetes or risk factors should regularly check their blood sugar control status. Moreover, there is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be cautioned before and during treatment. This medication should not be administered to patients with hypersensitivity or lactose intolerance, and caution should be exercised in patients with orthostatic hypotension, seizure history, impaired judgment, thermoregulation issues, or dysphagia. Common side effects such as drowsiness, dizziness, insomnia, anxiety, tremors, vomiting, constipation, headaches may occur, so caution should be taken when driving or operating hazardous machinery. This medication is also used for children and adolescents, but even in these cases, there is a possibility of side effects, so it should be strictly taken under physician's guidance. If any unusual symptoms or side effects appear during treatment, the patient must immediately consult healthcare professionals to receive appropriate care.

• Suicidal thoughts
• suicidal behavior
• anxiety
• restlessness
• panic attacks
• insomnia
• irritability
• hostility
• aggression
• impulsivity

This medication should be stored in a tightly sealed container to prevent the ingress of air or moisture, ideally at room temperature between 1°C and 30°C. This helps maintain the efficacy of the medication and prevent degradation.

Appearance

White round tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle