Serotapin 300 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine 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 daily dose of 300～400 mg. The dose may be adjusted within the range of 150～750 mg/day according to each patient's clinical response and tolerability. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. Whether used 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, in increments of no more than 200 mg per day. The dose may be adjusted within the range of 200～800 mg/day according to each patient's clinical response and tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose should reach 300 mg by day 4: 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, 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. The dose may be adjusted within the range of 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance treatment. 3. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start this medicine 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 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.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults; therefore, careful judgment from a physician and vigilant observation from patients and guardians are necessary during use. While taking this medication, blood sugar levels may rise, leading to symptoms of diabetes or hyperglycemia, so patients with diabetes or risk factors should monitor their blood sugar levels regularly and pay close attention to symptoms. Neuroleptic malignant syndrome, a rare but serious side effect, may occur. If symptoms such as high fever, muscle rigidity, or changes in consciousness occur, immediate medical attention is required. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if unusual movements or symptoms arise, consider adjusting the dosage or discontinuation. In elderly patients with dementia, there may be an increased risk of death associated with the use of this medication, warranting special caution. Hematological abnormalities such as severe neutropenia or agranulocytosis may occur, so if the white blood cell count drops, administration should be stopped immediately and symptoms of infection should be monitored closely. In patients at risk for cerebrovascular diseases, the likelihood of stroke may be increased, necessitating cautious administration. As there is a risk of venous thromboembolism, patients with risk factors for thrombosis should be assessed prior to use and preventive measures should be taken. Side effects such as orthostatic hypotension may occur in patients with cardiovascular diseases or hypotension, requiring dosage adjustment and monitoring of their condition. Serious skin adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may occur, so if rashes, fever, or lymphadenopathy present, the medication should be discontinued immediately. This drug should not be used in patients with certain conditions or diseases (e.g., comatose state, certain genetic lactase deficiency, patients with a history of diabetes). For patients with impaired liver function, cardiovascular diseases, and the elderly, it is advisable to start at a lower dose and gradually increase while monitoring carefully. Women who are pregnant or breastfeeding should carefully consider the risks and benefits before administration as it may affect the fetus or newborn, and breastfeeding is recommended to be avoided during treatment. This medication may cause central nervous system side effects such as drowsiness, dizziness, and decreased attention, so caution is advised when driving or operating dangerous machinery. Potential interactions leading to exacerbated side effects may occur when taken with other central nervous system depressants, alcohol, or other specific medications; therefore, consult a physician before combining. Sudden discontinuation of this medication may result in withdrawal symptoms; therefore, dosage should be gradually reduced under a physician's direction when discontinuing.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

Store this medication in a tightly sealed container to prevent air or moisture from entering. Additionally, it is important to keep it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle