Arabil Tablet 1mg (Aripiprazole (Micronized))

Adult dose

1. Adults with schizophrenia 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 a 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 maintenance treatment of schizophrenia with this drug was demonstrated in a clinical trial of relapse prevention versus placebo at a dose of 15 mg once daily in patients with schizophrenia who had been stabilized on another antipsychotic for at least 3 months. When switching from another antipsychotic to this drug, it is generally most appropriate to start this drug while gradually reducing the dose of the existing medication. The period of concomitant use of most antipsychotics should be minimized. 2. Treatment of manic and mixed episodes associated with bipolar disorder in adults As monotherapy or adjunctive therapy with lithium or valproate, the recommended initial dose is 15 mg once daily, with or without food. The dose may be increased to 30 mg per day according to clinical response. Doses above 30 mg per day have not been evaluated in clinical trials. Maintenance therapy: The efficacy of maintenance treatment in bipolar I disorder was demonstrated in a clinical trial in patients stabilized on this drug (15 mg or 30 mg once daily as monotherapy) for at least 6 weeks. 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 drug as adjunctive treatment for major depressive disorder has been established at doses of 2~15mg per day. The dose should be increased gradually by no more than 5mg at intervals of at least 1 week. 6. Dose adjustment for CYP450 interactions Dose adjustment is recommended for CYP2D6 poor metabolizers and patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or strong CYP3A4 inducers (see Table 1). When a concomitant medication is discontinued, adjust the dose of aripiprazole to the original dose; when a CYP3A4 inducer is discontinued, adjust the dose over 1~2 weeks. Thereafter, the dose may be adjusted according to clinical response. 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

Adolescents with schizophrenia (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 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. A dose of 30 mg per day was not more effective than 10 mg per day. Pediatric patients with bipolar I disorder (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 and 30 mg per day. The initial dose is 2 mg per day, increased to 5 mg after 2 days and to 10 mg after another 2 days. Thereafter, the dose should be increased in 5 mg increments. Pediatric patients with irritability associated with autistic disorder (6-17 years): Efficacy has been demonstrated at doses of 5 mg to 15 mg per day. The recommended initial dose is 1 mg or 2 mg per day and should be increased to 5 mg per day, and, if necessary, thereafter to 10 mg or 15 mg per day. Dose adjustments up to 5 mg per day should be made gradually at intervals of at least 1 week. Pediatric patients with Tourette's disorder (6-18 years): Efficacy has been demonstrated at doses of 2 mg to 20 mg per day. The initial dose is 2 mg per day, with gradual increases in 5 mg increments at intervals of at least 2 weeks.

This medication may increase the risk of suicidal ideation in pediatric, adolescent, and young adult patients with major depressive disorder or other psychiatric disorders, thus physicians should carefully assess the risks and benefits when prescribing this medication. Patients of all ages should be closely monitored for any changes in mood, suicidal thoughts, or behaviors during treatment, and family members or caregivers should also watch closely. Appropriate screening is required before prescribing this medication to patients suspected of having bipolar disorder, as manic symptoms or mixed episodes may occur, which requires caution. This medication can cause a serious side effect known as neuroleptic malignant syndrome, which necessitates immediate contact with healthcare professionals if symptoms such as high fever, muscle rigidity, changes in mental status, or autonomic nervous system abnormalities occur. Prolonged use may increase the risk of irreversible tardive dyskinesia; therefore, it should be used at the minimum effective dose and for the shortest duration necessary, with immediate consultation with a physician if symptoms arise. In elderly patients with dementia-related mental disorders, there is an increased risk of cerebrovascular accidents such as stroke and higher mortality rates associated with this medication, thus its use is not recommended. It can affect blood glucose control, so diabetic patients or those with risk factors should regularly monitor their blood sugar levels. There is a risk of venous thromboembolism, so patients with thrombotic risk factors should have careful assessment and preventive measures before and during the use of this medication. It should not be administered to patients with hypersensitivity to this medication or specific genetic issues such as lactose intolerance. Caution is needed in patients with orthostatic hypotension, seizure history, or cognitive and motor impairment, and symptoms such as drowsiness or dizziness may occur, thus avoiding driving or operating dangerous machinery is advised. Thermoregulatory ability may be impaired, thus caution is needed during excessive exercise or exposure to high-temperature environments. Patients with dysphagia should be monitored carefully for the risk of aspiration pneumonia. Common side effects during treatment may include nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, akathisia, drowsiness, fatigue, weight gain, nasopharyngitis, increased appetite, sedation, tremor, restlessness, blurred vision, excessive salivation, myalgia, arthralgia, musculoskeletal stiffness, palpitations, increased blood sugar, elevated blood pressure, decreased appetite, fever, thirst, polyuria, nocturia, dysmenorrhea, runny nose, itching, hair loss, hirsutism, thrombocytopenia, leucopenia... It is important to consult healthcare professionals immediately if any severe or persistent adverse reactions occur.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Therefore, it is important to avoid direct sunlight and not to place it in excessively hot or cold areas.

Appearance

White rectangular tablets

Package unit

30 tablets/bottle, 100 tablets/bottle