Quetiapine Tablets 200 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This drug 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, adjust to the usual effective dose of 300～400 mg daily. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 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 drug is taken twice daily, with or without food. As monotherapy or 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. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depressive episodes associated with bipolar disorder: - Adults: This drug is taken once daily at bedtime, with or without food. The total daily dose 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 drug, 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. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, 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 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, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults : As with other antipsychotics, this drug should be administered with caution to older adults, particularly when starting treatment. Older patients should start this drug 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 : After oral administration of quetiapine, clearance 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 in patients with known hepatic impairment. Patients with renal or hepatic impairment should start this drug at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

Safety and efficacy have not been established in children and adolescents.

This medication may increase the risk of suicidal ideation and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions; therefore, physicians should carefully assess risks and benefits when administering it to patients in these age groups. This drug can increase blood glucose in patients with diabetes or risk factors for diabetes, so blood glucose levels should be checked periodically and symptoms of hyperglycemia should be closely monitored. Rarely, serious side effects known as neuroleptic malignant syndrome may occur; if symptoms such as high fever, muscle rigidity, or changes in mental status appear, prompt medical attention should be sought. Long-term use may lead to extrapyramidal symptoms and tardive dyskinesia; if abnormal movement symptoms occur, consideration should be given to dose adjustment or discontinuation. The use of this medication is not recommended in elderly patients with dementia due to an increased risk of mortality. Severe agranulocytosis or neutropenia may occur, so consultation with a physician should be sought immediately if symptoms of infection develop. Patients at risk for cerebrovascular disease may have an increased risk of stroke, hence careful monitoring during use is required. There is a risk of venous thromboembolism; patients with risk factors for thrombosis should be pre-screened and take preventive measures. In patients with cardiovascular disease or hypotension, orthostatic hypotension may occur, necessitating caution during initial dosage adjustment and dose escalation. Severe skin reactions may occur; if widespread rash, fever, or lymphadenopathy occurs, the medication should be stopped immediately and a physician notified. This medication should not be administered to patients with hypersensitivity to specific ingredients, patients in a coma, those receiving central nervous system depressants, those receiving epinephrine, patients with diabetes, and those with lactose intolerance. In patients with impaired liver function, cardiovascular disease, seizure disorders, elderly patients, those at risk for suicide, pregnant or nursing women, careful administration is necessary; dose adjustments and monitoring of conditions are important. During administration of this drug, common side effects such as drowsiness, dizziness, dry mouth, weight gain, extrapyramidal symptoms, and others may occur, therefore symptoms that may affect daily living should be noted. In case of overdose, symptoms such as drowsiness, hypotension, and tachycardia may occur, and there is no specific antidote, so appropriate treatment should be sought immediately at a hospital. Caution is required when driving or operating hazardous machinery, and the combination with alcohol or central nervous system depressants may significantly exacerbate drowsiness or reduced reactions. During pregnancy, use should only occur when the necessity is clear, as it may affect the fetus; nursing mothers are advised to avoid breastfeeding while on this medication. There are many drug interactions, so if other medications are being taken, one must definitely consult a physician or pharmacist to use safely.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• elevated 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 protect from air and moisture, and it is best kept at a cool temperature below 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle