Seroquel Tablets 100 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 the range of 150～750 mg/day according to each patient's clinical response and tolerability. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine 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. The dose may be adjusted within the range of 200～800 mg/day according to each patient's clinical response and tolerability; 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 should reach 300 mg by day 4: 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials have shown 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. The dose may be adjusted within the range of 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance treatment. 3. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start this medicine at 25 mg/day, with gradual increases of 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment The clearance of quetiapine after oral administration 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 this medicine at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

4. Children and adolescents The safety and efficacy of this medicine have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behaviors in young patients with major depressive disorder or psychiatric conditions, so careful judgment by the physician and close observation of the patient and caregiver are necessary during its use. Blood glucose may rise during treatment, possibly worsening diabetes; therefore, patients with diabetes or a family history of diabetes should have regular blood glucose checks and carefully observe for symptoms of hyperglycemia. Rare but serious adverse effects known as neuroleptic malignant syndrome may occur; if symptoms such as high fever, muscle rigidity, or changes in mental status develop, medical personnel should be informed immediately. Prolonged use may result in extrapyramidal symptoms or tardive dyskinesia, so if abnormal movement symptoms occur, consult a doctor. Elderly patients with dementia may be at an increased risk of death due to the use of this drug, and extra caution is required during administration. Severe blood-related conditions like severe neutropenia or agranulocytosis may occur, thus regular monitoring of white blood cell counts is necessary, and immediate action should be taken if any signs of infection arise. Patients at risk for cerebrovascular disease should be cautious, as the risk of stroke and other vascular diseases may increase with this medication. There is a risk of venous thromboembolism; therefore, patients with thrombotic risk factors should be monitored closely before and after taking this medication. Patients with cardiovascular disease or hypotension may experience side effects like orthostatic hypotension, so initial dose adjustment and monitoring are necessary. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may occur, and any signs of rash or fever should be reported to a doctor immediately. This medication should not be administered to patients with certain genetic disorders, and pregnant or nursing women should use it cautiously due to the potential risks to the fetus or newborn. In case of overdose, symptoms such as drowsiness, sedation, hypotension, and tachycardia may occur, and since there is no specific antidote, immediate medical attention is required. This drug may cause drowsiness and dizziness; caution should be exercised when driving or operating hazardous machinery. Additionally, combining this medication with other central nervous system drugs or alcohol may exacerbate side effects; hence, concomitant use should be approached with care. When discontinuing treatment, the dosage should be gradually reduced to prevent withdrawal symptoms or worsening of symptoms due to sudden cessation.

• 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 protect it from exposure to air or moisture, preferably at a cool temperature below 30 degrees Celsius. Doing so helps maintain the drug's effectiveness for a longer duration.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle