Quetiapine Tablets 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medication 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. 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 adult patients with schizophrenia. Patients should be reassessed regularly to determine whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medication 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, 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. (2) Treatment of depression associated with bipolar disorder: - Adults: This medication 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 the pivotal clinical trials of this medication, 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 medication, reduction to as low as 200 mg has been shown to be possible in clinical trials. (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, given twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults: As with other antipsychotics, this medication should be administered with caution to older adults, particularly when starting treatment. Older patients should start this medication 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: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because quetiapine is primarily metabolized in the liver, it should be administered cautiously to patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medication at 25 mg/day, 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 medication have not been established in children and adolescents.

This medication is primarily used to treat psychiatric disorders, particularly prescribed for depression, schizophrenia, and bipolar disorder. During the course of treatment, suicidal thoughts or behaviors may increase, so it is essential for young patients, particularly those between the ages of 18 and 24, to be closely monitored by a physician. It may affect blood sugar control, so diabetic patients or those with risk factors for diabetes should regularly monitor their blood sugar and consult medical personnel immediately if any abnormal symptoms arise. Serious side effects may occur, such as neuroleptic malignant syndrome characterized by severe muscle rigidity, high fever, and changes in mental status; if these symptoms occur, discontinue the medication immediately and visit a medical institution. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so consult a physician if any abnormal symptoms arise. In elderly patients with dementia, the use of this medication may increase the risk of death, so caution should be exercised. Rare blood-related adverse reactions such as severe neutropenia and agranulocytosis have been reported; if a low white blood cell count is observed, the medication should be discontinued, and symptoms of infection should be monitored closely. There may be an increased risk of cerebrovascular disease, so patients with risk factors for stroke should be monitored closely. There is also a risk of venous thromboembolism, so patients with thrombotic risk factors should be carefully monitored before and during treatment. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension when taking this medication, so care should be taken when standing up or experiencing dizziness. This medication may cause severe skin reactions, so discontinue use immediately if symptoms such as rash, fever, or lymph node swelling occur. Pregnant or breastfeeding women should use this medication cautiously, as it may affect the fetus or newborn; use should be avoided during breastfeeding unless necessary. This medication is not recommended for children and adolescents as safety and efficacy have not been established. In elderly patients, start at a low dose and closely monitor for symptoms of dizziness or hypotension. In case of overdose, symptoms such as drowsiness, sedation, and low blood pressure may appear, requiring immediate medical attention. Care should be taken when driving or operating hazardous machinery during the course of this medication, and the use of alcohol or central nervous system depressants may enhance side effects. Lastly, abrupt discontinuation of this medication may lead to withdrawal symptoms, so dosage should be gradually reduced according to a doctor's instructions.

• 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 sealed container to prevent air or moisture from entering and kept in a cool place below 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle