Quetiapine Tablets 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medicine 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 individual patient's clinical response and drug 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 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 medicine is taken twice 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. Depending on the individual patient's clinical response and drug tolerability, the dose may be adjusted within the range of 200～800 mg/day, and 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, 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 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, reduction to a minimum of 200 mg was 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 the range of 300～800 mg/day, administered twice daily. It is important to use the lowest 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 this medicine 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. 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

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

This medication is used for the treatment of psychiatric disorders and is not approved for use in children and adolescents, so it is advisable not to administer it. There may be an increase in suicidal thoughts or behaviors while taking this medication, especially in young adult patients aged between 18 and 24, necessitating careful judgment and continuous observation by a physician. Patients with diabetes or a family history of diabetes are at risk of increased blood sugar levels, so regular blood sugar checks should be done before and during treatment. This medication can rarely cause a serious side effect called neuroleptic malignant syndrome, and if symptoms such as high fever, muscle rigidity, or changes in mental status occur, immediate consultation with healthcare professionals is necessary. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms occur, dosage adjustment or discontinuation should be considered. Care should be taken in elderly patients with dementia, as there may be an increased risk of death. A decrease in blood cell counts, especially neutropenia or agranulocytosis, may occur, so if symptoms of infection or fever arise, healthcare professionals should be informed immediately. Patients with cardiovascular disease or cerebrovascular disease may have an increased risk of hypotension or thrombosis while taking this medication, so careful observation is necessary. This medication may affect the central nervous system, causing drowsiness or dizziness, so caution is advised when driving or operating dangerous machinery. Women who are pregnant or breastfeeding may affect the fetus or newborn, so they must consult with a doctor before taking this medication. During treatment, sudden discontinuation should be avoided, and dosage should be gradually reduced according to a physician's instructions to prevent acute withdrawal symptoms. Taking this medication alongside other central nervous system depressants or alcohol may worsen side effects, so caution is necessary when combined. In case of overdose, immediate medical intervention and intensive care are required as there is no specific antidote, and patients should not adjust their dosage on their own.

• 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 protect it from air and moisture, and it is important to maintain a temperature below 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance

Orange round film-coated tablets

Package unit

30 tablets (10 tablets/PTP × 3), 30 tablets/bottle, 200 tablets/bottle