Ecumin Tablet 300 mg (Quetiapine Fumarate)

Adult dose

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. 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. 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. 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. 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. 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

Safety and efficacy have not been established in pediatric and adolescent populations.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with depression or other psychiatric disorders; therefore, consultation with a physician should be conducted before administration. Patients receiving this medication should have their blood sugar levels regularly checked as they may rise, indicating diabetes or hyperglycemic symptoms. A serious side effect known as neuroleptic malignant syndrome may occur, so if high fever, muscle rigidity, or changes in mental status occur, immediate medical attention should be sought. Long-term use may cause extrapyramidal symptoms or tardive dyskinesia; if unusual symptoms arise, administration should be discontinued or adjusted. Caution is necessary when using this drug in elderly patients with dementia as it may increase the risk of death. Severe blood abnormalities such as agranulocytosis may occur, so if white blood cell counts decrease, administration should be stopped immediately. Patients at risk for cerebrovascular disease should be especially cautious as this medication may increase the risk of stroke. Due to the risk of venous thromboembolism, patients with thrombotic risk factors should take preventive measures while on this medication. Patients with cardiovascular disorders or hypotension may experience orthostatic hypotension, necessitating dosage adjustment if symptoms occur. Severe adverse skin reactions may rarely occur; if symptoms such as skin rash or fever develop, the medication should be stopped immediately. This medication should not be administered to specific patients (e.g., hypersensitive patients, comatose patients, patients taking specific central nervous system depressants, patients with diabetes, etc.). Caution is needed for patients with liver dysfunction, the elderly, patients with cardiovascular disease, or those with risk factors for diabetes; close monitoring of their condition is required. Pregnant or breastfeeding women should have adequate consultation with a physician as it may affect the fetus or newborn. Drowsiness or dizziness may occur while taking this medication, so driving or operating dangerous machinery should be avoided. There may be potential drug interactions, so it is essential to inform the healthcare provider of any other medications being taken. If treatment is stopped suddenly, withdrawal symptoms or worsening of symptoms may occur; therefore, the dosage should be gradually reduced. In the case of an overdose, immediate emergency treatment is required; there is no specific antidote, so treatment should be administered according to medical directives.

• 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 sealed container that is airtight and well-ventilated, and it is important to maintain a temperature below 30 degrees Celsius. Proper storage conditions will help preserve the medication's effectiveness for an extended period.

Appearance

White oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle