Quetiapine Tablets 200 mg (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 the individual patient's clinical response and drug tolerability, the dose may be adjusted within the range of 150～750 mg/day. 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: This medicine is taken twice daily, with or without food. As monotherapy or as adjunctive therapy to mood stabilizers (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, with increases of no more than 200mg per day. Depending on the individual patient's clinical response and drug tolerability, the dose may be adjusted within the range of 200～800 mg/day, and 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 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, reduction to a minimum of 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 lowest effective dose for maintenance therapy. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting treatment. Elderly patients should start this medicine at 25 mg/day, with gradual increases of 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 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.

This medication may increase the risk of suicidal thoughts or behaviors in younger patients with major depressive disorder or psychiatric conditions; therefore, careful monitoring by a physician and thorough observation by caregivers is required when using this medication. This medication can elevate blood sugar levels; thus, diabetic patients or those at risk for diabetes should regularly monitor blood sugar and be adequately informed about the symptoms of hyperglycemia. Rare and serious side effects known as neuroleptic malignant syndrome may occur; if symptoms such as high fever, muscle rigidity, or changes in mental status appear, immediate medical attention must be sought. Long-term use may cause tardive dyskinesia, which presents with abnormal movement symptoms, so if such symptoms arise, consideration for dose adjustment or discontinuation should be made. The risk of death may be increased in elderly patients with dementia; therefore, this medication is not recommended for treating dementia-related psychosis. This medication can cause severe agranulocytosis or neutropenia; thus, it should be discontinued if patients have low white blood cell counts, and attention to infection symptoms is necessary. In patients at risk for cerebrovascular diseases, there may be an increased risk of stroke, so it should be used cautiously. Venous thromboembolism risk exists; therefore, patients with thromboembolism risk factors should take preventive measures and be carefully monitored. Patients with cardiovascular diseases or hypotension should be aware of symptoms related to orthostatic hypotension during initial dosage adjustments. Severe skin reactions may occur; if extensive rashes, fever, lymph node swelling, or other symptoms arise, usage should be immediately discontinued. This medication should not be administered to patients with specific allergies or comatose states, those taking certain medications, diabetic patients, or patients with lactose intolerance. In certain patient groups, such as those with liver disorders, cardiovascular diseases, convulsive disorders, elderly patients, and pregnant women, it should be administered cautiously, and dosing should be adjusted slowly. Common side effects include drowsiness, dizziness, dry mouth, weight gain, and may involve close attention while driving or operating hazardous machinery. The risk of side effects may increase when co-administered with other central nervous system depressants, alcohol, or certain antidepressants, so physician instructions must be followed when co-administering. Pregnant or breastfeeding women should consult with a physician as this medication may affect the fetus or newborn.

• 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 closed container to prevent exposure to air or moisture, and it should be kept in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3), 30 tablets/bottle, 200 tablets/bottle