Serotipin 100 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This drug is taken 2 times 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. 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 adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder Adults: This drug is taken 2 times daily, with or without food. As monotherapy or as adjunctive therapy to mood stabilizers (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. Treatment of depression associated with bipolar disorder Adults: This drug is taken once daily at bedtime, with or without food. 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 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, reduction to as low as 200 mg has been shown to be possible in clinical trials. 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 be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300～800 mg/day, administered 2 times daily. It is important to use the minimum effective dose for maintenance therapy. Elderly patients: As with other antipsychotic drugs, this drug should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start this drug at 25 mg/day, with gradual increases of 25～50 mg per day; the effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine 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 drug at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

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

This medication may increase the risk of suicidal thoughts or actions in young patients with major depressive disorder or psychiatric conditions, so careful monitoring is necessary when prescribing it to patients aged 18 to 24. Additionally, this drug can elevate blood sugar levels, so diabetes patients or those with risk factors for diabetes should periodically check their blood sugar control status. Neuroleptic malignant syndrome, a serious side effect, can occur rarely; therefore, immediate consultation with a doctor is necessary if symptoms such as high fever, muscle rigidity, or changes in mental status occur. Long-term use may result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia; thus, if abnormal symptoms appear, dosage adjustments or discontinuation should be considered. Use is not recommended in elderly patients with dementia, as there may be an increased risk of death. This drug may affect blood cell counts, particularly causing neutropenia; therefore, attention to infection symptoms and regular blood tests are necessary. Careful use is required for patients with a history of cardiovascular disease or cerebrovascular disease due to potential increases in orthostatic hypotension and risk of cerebrovascular disease. There is a risk of venous thromboembolism; thus, patients with thrombotic risk factors should be closely monitored before and after administration. This drug is metabolized in the liver, so patients with impaired liver function should start at a low dose and be monitored closely. Women who are pregnant or nursing should consult a doctor before administration, as it may affect the fetus or newborn, and should avoid use during breastfeeding. Safety and efficacy have not been established in children and adolescents, and their use is not advised. Overdose may cause drowsiness, sedation, and hypotension; thus, immediate emergency treatment is necessary, and there is no specific antidote. This drug affects the central nervous system and may cause drowsiness or dizziness, necessitating caution when driving or operating dangerous machinery. Moreover, concurrent use with other central nervous system depressants or alcohol may enhance these effects; caution is advised with co-administration. This drug should not be administered to patients with hypersensitivity to certain components, those in a comatose state, or those on specific drugs concurrently.

• 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 ingress, preferably in a cool place below 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for a longer period.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle