AcuMin Tablet 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine twice daily, with or without food. The total daily dose for the first 4 days is 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. From Day 4 onward, adjust to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and drug tolerability. Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. As monotherapy or adjunctive therapy to a mood stabilizer (lithium or valproate), the total daily dose for the first 4 days is 100 mg on Day 1, 200 mg on Day 2, 300 mg on Day 3, and 400 mg on Day 4. The total daily dose may be increased to 800 mg by Day 6, in increments of no more than 200mg per day. Depending on each patient's clinical response and drug tolerability, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose for the first 4 days should reach 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. In confirmatory clinical trials of this medicine, doses of 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, 300 mg on Day 4, 400 mg on Day 5, and up to 600 mg on Day 8 were administered. The recommended daily dose is 300 mg. Antidepressant effects were observed with both 300 mg and 600 mg, but there was no additional benefit with 600 mg. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, reduction to as low as 200 mg was shown to be possible in clinical trials. (3) Prevention of recurrence of bipolar disorder: Adults: To prevent recurrence of manic, mixed, or depressive episodes associated with bipolar disorder, patients who responded to quetiapine during acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults As with other antipsychotics, this medicine should be administered cautiously to older adults, particularly at the start of treatment. Older patients should start with 25 mg/day of this medicine, with gradual increases of 25～50 mg daily; the effective dose in older adults may be lower than that in younger patients. 5. Patients with renal and hepatic impairment Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal and hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer cautiously to patients with known hepatic dysfunction. Patients with renal and hepatic impairment should start with 25 mg/day of this medicine and gradually increase by 25～50 mg daily to the effective dose.

Child dose

Children and adolescents: Safety and efficacy have not been established.

This drug should be used with caution in children, adolescents, and young adults with major depressive disorder or psychiatric conditions due to an increased risk of suicidal impulses and behaviors. Patients at risk of diabetes or hyperglycemia should have their blood sugar levels checked periodically, and patients and their families should be well-informed about symptoms of hyperglycemia. There is a risk of serious side effects known as Neuroleptic Malignant Syndrome, so if high fever, muscle rigidity, or changes in mental state occur, consult a doctor immediately. Prolonged use may lead to extrapyramidal symptoms and tardive dyskinesia, so dosage adjustment or discontinuation should be considered if abnormal symptoms appear. The use in elderly patients with dementia may increase the risk of death; therefore, administration is not recommended. Severe neutropenia or agranulocytosis may occur, so regular monitoring of white blood cell count is needed, and treatment should be initiated immediately for any signs of infection. Caution is needed for patients with a risk of cerebrovascular disease and there is a risk of venous thrombosis, so thrombotic risk factors should be identified and monitored. Patients with cardiovascular disease or hypotension must be observed carefully for dizziness or orthostatic hypotension symptoms, especially at the initial administration. Severe skin reactions may occur, so if symptoms like rash, fever, lymphadenopathy appear, immediate discontinuation of the medication is necessary. This drug should not be given to patients with certain diseases or on certain medications, and patients with impaired liver function should start at a low dose and gradually increase. Pregnant or nursing women should consult a specialist and use caution as there may be effects on the fetus and newborn. This medication commonly causes side effects such as drowsiness, dizziness, and dry mouth, and caution is advised when operating vehicles or machinery. Sudden discontinuation during treatment may cause withdrawal symptoms, so the dosage should be gradually reduced. Additionally, there may be interactions with other medications, so any medications being taken should be discussed with a doctor or pharmacist.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• reduced hemoglobin
• extrapyramidal symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is important to maintain a temperature below 30 degrees. Therefore, it is advisable to store it in a cool place avoiding direct sunlight.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle