Quetiapine Fumarate 200 mg Tablets

Adult dose

1. Schizophrenia Adults: This medication is taken twice daily, regardless of meals. 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. 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 adult patients with schizophrenia. Patients should be reassessed regularly to determine whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medication is taken twice daily, regardless of meals. 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, with increases of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medication is taken once daily at bedtime, regardless of meals. The total daily dose for the first 4 days should reach 50 mg on day 1, 100 mg on day 2, 20-0 mg on day 3, and 300 mg on day 4. In the pivotal clinical trials of this medication, 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 medication, reduction to as low as 200 mg has been 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 300～800 mg/day, given twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults: As with other antipsychotics, this medication should be administered with caution to older adults, particularly when starting treatment. Older patients should start this medication 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: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because quetiapine is primarily metabolized in the liver, it should be administered cautiously to patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

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

This drug is primarily used for the treatment of psychiatric disorders, particularly helping with various mental health issues like depression, schizophrenia, and bipolar disorder. When taking this medication, there may be an increased risk of suicidal thoughts or behavior, especially in young patients aged 18 to 24, thus careful assessment and ongoing monitoring by the physician are needed. Blood sugar levels may increase or diabetic symptoms may worsen, so individuals with diabetes or a family history of diabetes should regularly monitor their blood sugar and consult a healthcare professional immediately if any abnormal symptoms occur. Serious neurological symptoms such as muscle rigidity, high fever, or changes in consciousness may appear. If these symptoms occur, discontinue the medication immediately and visit a hospital. Long-term use may lead to abnormal movements, so if any unusual movements are felt, consult a doctor. Particular caution is required in elderly patients as this medication may increase the risk of mortality. This medication may lower white blood cell counts in the blood, increasing susceptibility to infections, so it is important to inform medical staff immediately if fever or infection symptoms occur. Patients with cardiovascular or cerebrovascular disease should carefully monitor their blood pressure or heart condition while taking this medication. The risk of thrombosis may increase during drug treatment; thus, if symptoms such as leg pain, swelling, or difficulty breathing occur, visit a hospital immediately. Dizziness or drowsiness may occur when first taking this medication, hence caution is advised when driving or operating dangerous machinery. Women who are pregnant or nursing should consult a doctor before taking this medication, as withdrawal symptoms may occur in newborns. Avoid sudden changes in dosage during treatment, and taper off gradually to minimize side effects when discontinuing. This drug may have intensified side effects when taken together with other central nervous system drugs or alcohol, so caution is necessary when used in combination. Severe drowsiness, low blood pressure, or heart issues may occur with overdose, necessitating immediate emergency treatment. The safety of this medication has not been established in children or adolescents, and its use is not recommended for them. It is important to consult a healthcare professional immediately if there are any unusual symptoms or discomfort during treatment.

• 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 to prevent air or moisture from entering, and it is advisable to keep it in a cool place below 30 degrees Celsius. This way, the effectiveness of the medication can be well maintained and deterioration can be prevented.

Appearance

White, round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle