Seroafin Tablet 25mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medicine 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. Depending on each patient's clinical response and tolerability, 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 regularly reassessed to determine whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medicine 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, in increments of no more than 200mg per day. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medicine 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 pivotal 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 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 the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting treatment. Elderly patients should start treatment with 25 mg/day of this medicine, with gradual increases of 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: 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 to patients with known hepatic impairment. Patients with renal or hepatic impairment should start treatment with 25 mg/day of this medicine, 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 medicine have not been established in children and adolescents.

This medication is used for the treatment of psychiatric disorders and can increase the risk of suicide associated with depression, so caution is required when administering it to children, adolescents, and young adults. During the use of this medication, blood sugar levels may increase, so patients with diabetes or at risk of hyperglycemia should regularly monitor blood glucose and observe symptoms. There is a risk of a serious side effect known as neuroleptic malignant syndrome, so if symptoms such as high fever, muscle stiffness, or changes in mental status occur, medical consultation should be sought immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if unusual movements are observed, dosage adjustment or discontinuation should be considered. In elderly patients with dementia, the risk of death may be increased, so its use is not recommended. Decreased blood cell counts, particularly neutropenia and agranulocytosis, may rarely occur, so if symptoms of infection appear, medical personnel should be notified immediately. Patients with cerebrovascular or cardiovascular diseases should use this medication cautiously due to the risk of stroke or hypotension. There is also a risk of venous thrombosis, so caution is needed in patients with thromboembolic risk factors. This medication metabolizes in the liver, so patients with impaired liver function should start at a low dose, monitoring their condition and gradually increasing the dosage. Pregnant or nursing women should consult a physician as this medication may affect a fetus or newborn. Common side effects include drowsiness, dizziness, dry mouth, weight gain, etc., so caution is required when driving or operating dangerous machinery. Abruptly discontinuing this medication may lead to withdrawal symptoms, so the dosage should be gradually reduced according to the physician's instructions. The co-administration of this medication with other central nervous system depressants or alcohol may worsen side effects, so medical personnel should be informed of other medications. Additionally, there may be interactions when used with certain antidepressants or antifungal medications, so attention should be paid to concomitant drugs. This medication is not recommended for children and adolescents, as safety and efficacy have not been established. In the elderly, it should be initiated at a low dose, carefully monitored, and gradually increased. In cases of overdose, severe drowsiness, hypotension, and tachycardia may occur, and since no specific antidote exists, appropriate treatment should be sought immediately at a medical facility. When storing this medication, keep it out of the reach of children and do not transfer it to another container.

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

This medication should be stored in a sealed container to prevent exposure to air or moisture and kept at a cool temperature below 30 degrees Celsius. This helps maintain the drug's effectiveness.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle