Myeongmun Quetiapine Tablet (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medicine is taken 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on each patient's clinical response and tolerability, the dose may be adjusted within 150～750 mg/day. - Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine whether maintenance treatment is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medicine is taken twice daily, with or without food. Whether used as monotherapy or as 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 200 mg per day. Depending on each patient's clinical response and 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: This medicine is taken once daily at bedtime, with or without food. The total daily dose should reach 300 mg by day 4, with doses of 50 mg on day 1, 100 mg on day 2, and 200 mg on day 3. 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 at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. (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 for 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 a range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance treatment. 3. Elderly patients : As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start at 25 mg/day and the dose should be increased gradually by 25～50 mg per day; the effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment : Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Patients with renal or hepatic impairment should start at 25 mg/day and the dose should be increased gradually by 25～50 mg per day until an effective dose is reached.

Child dose

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

This drug may increase the risk of suicidal thoughts and behavior in young patients with major depressive disorder or psychiatric illnesses, therefore close monitoring by a physician is required during treatment. Furthermore, blood glucose levels may increase while taking this medication, so patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar. A serious side effect known as Neuroleptic Malignant Syndrome may occur rarely, thus symptoms such as high fever, muscle rigidity, and changes in mental state should be observed closely. Long-term use may result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia, and if abnormal symptoms appear, consultation with a physician should be sought immediately. In elderly patients with dementia, this drug may increase the risk of death, so it must be used with great caution. Severe neutropenia or agranulocytosis may occur with a sudden drop in white blood cells, so it is crucial to inform healthcare professionals promptly if any signs of infection arise. Patients at risk for cerebrovascular diseases may have an increased risk of stroke, therefore caution is advised. This medication can increase the risk of venous thromboembolism, so patients with thrombotic risk factors should consult a physician before use. Patients with cardiovascular diseases or hypotension may experience symptoms like orthostatic hypotension, so it's recommended to start with a low dose and monitor their condition upon initiation of treatment. Severe skin reactions such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis may occur; thus, if symptoms like skin rash or fever develop, use should be discontinued immediately and the patient should visit the hospital. This medication should not be given to patients with specific genetic lactose intolerance, nor to those in a coma or using certain central nervous system depressants, or those receiving epinephrine. Patients with compromised liver function, cardiovascular disease, a history of seizures, older adults, pregnant or breastfeeding women should use this medication carefully, particularly considering possible effects on the fetus in pregnant women. Abrupt discontinuation of this medication may result in withdrawal symptoms or worsen psychiatric symptoms; therefore, doses should be gradually reduced. Various side effects like drowsiness, dizziness, dry mouth, weight gain, and lipid abnormalities in the blood may occur, so consultation with a physician is advised if any abnormal symptoms arise. Care should be taken when driving or operating dangerous machinery, and taking this medication with alcohol or other central nervous system depressants may exacerbate side effects. Lastly, there are interactions with certain medications, so if taking other drugs, it is essential to inform a physician or pharmacist.

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

Store this medication in a tightly closed container to protect it from air and moisture, and it is recommended to keep it in a cool place at or below 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle