Quetiapine Tablets 200 mg (Quetiapine Fumarate)

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, 200 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 medication should be used cautiously in children, adolescents, and young adults with depression or psychiatric disorders, as it may increase the risk of suicidal thoughts or actions. Blood sugar levels may rise during treatment with this medication, so diabetic patients or those at risk for diabetes should frequently monitor and manage their blood sugar levels. This medication can rarely cause neuroleptic malignant syndrome, characterized by severe muscle rigidity, high fever, and changes in mental state, requiring immediate medical treatment if symptoms occur. Long-term use may cause tardive dyskinesia, leading to involuntary movements of the face or body; consult a doctor if abnormal symptoms arise. Special caution is necessary for elderly patients with dementia, as the risk of death may increase. Severe neutropenia or agranulocytosis, characterized by a dramatic decrease in white blood cells, may occur, necessitating immediate medical attention for any signs of infection. Patients at risk for cerebrovascular disease may experience an increased risk of stroke, requiring careful oversight. This medication may increase the risk of thrombosis, so patients with risk factors for thrombosis should be closely monitored. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension and should adjust doses gradually while monitoring their condition. Severe rash or desquamation, fever or other severe skin reactions may occur rarely; discontinue use immediately and seek medical help if any abnormal symptoms arise. This medication should not be used in patients with allergies to specific components, in comatose patients, those on certain medications, or those with diabetes. Patients with impaired liver function may experience increased blood levels, requiring starting at a lower dose while monitoring closely. Women who are pregnant or breastfeeding should consult a doctor before use, as it may affect the fetus or newborn. Discontinuing this medication suddenly may lead to withdrawal symptoms, so taper doses gradually. Common side effects include drowsiness, dizziness, dry mouth, weight gain, and others; caution is advised when driving or operating machinery. In case of overdose, severe drowsiness, hypotension, tachycardia may occur; there is no specific antidote, so immediate medical treatment is required. Caution should be exercised when taking this medication with other CNS medications or alcohol, as side effects may be aggravated. Drug interactions can alter blood levels of this medication, so inform the doctor of any concurrent medication use.

• 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 air and moisture, and it is important to keep it in a cool place below 30 degrees Celsius. This will help maintain the medication's effectiveness and prevent degradation.

Appearance

White circular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle