Serokel Tablet 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the clinical response and drug tolerability of each patient, 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 drug is taken twice daily, with or without food. As monotherapy or as adjunctive therapy with 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 200mg per day. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day, and the effective daily dose is 400～800 mg. (2) Treatment of depression 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 the pivotal 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, 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. Depending on the clinical response and tolerability of each patient, the twice-daily dose may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotics, this drug should be administered with caution to elderly patients, particularly when initiating treatment. Treatment should be started at 25 mg/day and gradually increased by 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 following 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. In patients with renal or hepatic impairment, treatment should be started at 25 mg/day and gradually increased by 25～50 mg per day until the effective dose is reached.

Child dose

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

This medication is used to treat psychiatric disorders, particularly effective in conditions such as depression, mania, and schizophrenia. During the use of this medication, suicidal thoughts or behaviors may increase, so young patients aged 18 to 24 require careful observation by a physician. It may raise blood sugar levels, causing patients at risk for diabetes or hyperglycemia to monitor their blood sugar regularly and observe symptoms. Serious neuroleptic malignant syndrome could occur, presenting with symptoms such as muscle rigidity, high fever, and changes in consciousness; therefore, immediate consultation with medical personnel is advised if these symptoms appear. Long-term use may lead to tardive dyskinesia, an involuntary movement disorder, and if symptoms appear, dose adjustments or discontinuation should be considered. Particular caution is required when using this medication in elderly patients with dementia due to an increased risk of mortality. Severe neutropenia or agranulocytosis may occur, necessitating regular blood tests to monitor the condition. Patients at risk for strokes may experience an increased risk of cerebrovascular disease when using this medication; thus, it should be used cautiously. Due to the risk of thrombosis, preventive measures should be taken if other risk factors for thrombosis are present. Patients with cardiovascular disease or low blood pressure may experience dizziness or orthostatic hypotension symptoms, especially during initial dosing. Rarely, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; if symptoms like skin rash or fever appear, discontinue use immediately and consult a physician. This medication should not be administered to patients with allergies to specific ingredients, in a coma, taking certain central nervous system depressants, receiving epinephrine, or to diabetic patients. Patients with impaired liver function should start with a low dose and gradually increase while closely monitoring their condition. Women who are pregnant or nursing should consult with a doctor as this medication can affect the fetus or newborn. Drowsiness or dizziness may occur during use; it is advisable to avoid driving or operating dangerous machinery. Abrupt discontinuation of this medication may lead to withdrawal symptoms or worsened symptoms; therefore, tapering off should be done following a physician’s directions.

• 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 air or moisture from entering and should be kept in a cool place below 30 degrees Celsius. This helps maintain the medication's effectiveness for a long time.

Appearance

White round film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)