EcuMin Tablet 200 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

The safety and efficacy of this medication have not been established in children and adolescents.

This medication can increase the risk of suicidal thoughts or behavior in young patients with major depressive disorder or other psychiatric conditions, so caution is required. Special care and monitoring are required for children, adolescents, and young adults. This medication may raise blood sugar levels, and patients with diabetes or at risk for diabetes should regularly test their blood sugar and observe for symptoms. In severe cases, it could lead to ketoacidosis or coma, and if any abnormal symptoms appear, immediate consultation with healthcare professionals is necessary. A rare but serious side effect known as Neuroleptic Malignant Syndrome may occur; if symptoms like high fever, muscle rigidity, or altered consciousness appear, the medication should be discontinued and immediate treatment sought. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so dosage adjustment or discontinuation should be considered if symptoms occur. The use of this medication in elderly patients with dementia is not recommended due to an increased risk of death. This medication can cause blood dyscrasias such as neutropenia and agranulocytosis, so regular monitoring of white blood cell counts is required, and healthcare professionals should be informed immediately if infection symptoms arise. Patients with a risk of cerebrovascular disease require caution, and the risk of venous thrombosis should be assessed and managed in advance. In patients with cardiovascular disease or hypotension, orthostatic hypotension may occur, so care should be taken when changing positions gradually, and dosage adjustment is needed if symptoms arise. Severe skin reactions may rarely occur; if symptoms like rash, skin peeling, or fever occur, medication should be stopped immediately. This medication is not to be given to individuals allergic to specific components, those in a comatose state, patients taking certain central nervous system depressants, patients receiving epinephrine, or patients with diabetes. Caution is required when administering to patients with impaired liver function, cardiovascular diseases, the elderly, pregnant women, and breastfeeding mothers, with the need for dosage adjustment and continuous monitoring of their condition. During treatment, side effects such as drowsiness, dizziness, dry mouth, weight gain, and changes in blood glucose and lipid levels may occur, so caution is necessary. This medication acts on the central nervous system and can induce drowsiness and decreased attention, so caution is required when driving or operating hazardous machinery. The effects may be augmented when taken with other central nervous system depressants or alcohol. There is a risk of serotonin syndrome, so symptoms should be closely monitored when used in conjunction with specific antidepressants. Use during pregnancy may affect the fetus and lead to neonatal withdrawal symptoms, so pregnant women should consult a physician before taking and breastfeeding mothers should avoid taking it. Overdose may result in severe drowsiness, hypotension, anticholinergic symptoms, etc., and there is no specific antidote, so supportive treatment based on symptoms is required. Therefore, regular medical care and monitoring during the use of this medication are crucial, and if adverse symptoms arise, consultation with medical professionals should be sought immediately.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also best to store it in a cool place below 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle