BL Quetiapine Tablets 100 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 the dose 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 tolerability. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. 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 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 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. In the confirmatory clinical trial 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. Clinical trials indicate that the dose may be reduced to as low as 200 mg in patients who tolerate the medicine. (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 be maintained on the same dose. The dose may be adjusted within a range of 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. 3. Elderly patients In elderly patients, start this medicine at 25 mg/day and gradually increase by 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 In patients with renal or hepatic impairment, start this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

This medication may increase the risk of suicidal thoughts or behaviors in younger patients with major depressive disorder or psychiatric disorders; thus, physicians should carefully decide on its administration. Patients taking this medication may have an increased risk of elevated blood sugar levels, so those with diabetes or a family history of diabetes should monitor their blood sugar levels regularly. A serious side effect known as neuroleptic malignant syndrome may rarely occur, so if high fever, muscle rigidity, or changes in mental status arise, immediate medical consultation is necessary. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia; therefore, if abnormal movements appear, dosage adjustments or discontinuation should be considered. Elderly patients with dementia may have an increased risk of death, thus use of this medication is not recommended. Severe agranulocytosis or neutropenia may occur, and patients with low white blood cell counts should discontinue use and be vigilant for symptoms of infection. Care is required when administering to patients at risk of cerebrovascular disease; venous thromboembolism is also a risk, so thrombus risk factors should be checked and preventive measures taken. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension; appropriate action should be taken if symptoms occur. Severe skin adverse reactions may arise; therefore, if symptoms such as skin rash or fever occur, immediate discontinuation is required. This medication should not be administered to specific patient groups (patients with hypersensitivity, comatose patients, patients taking barbiturates, etc.), and should be used cautiously in patients with liver disorders, cardiovascular diseases, and the elderly. Common side effects such as drowsiness, dizziness, and dry mouth may occur, thus caution should be used when driving or operating dangerous machinery. Pregnant women or those who may become pregnant, as well as nursing mothers, should consult a doctor before using this medication, as it may affect the fetus or newborn. In case of overdose, immediate emergency treatment is necessary, and since there is no specific antidote, appropriate medical measures according to the symptoms are crucial. The risk of side effects may increase when this medication is taken together with other central nervous system depressants or alcohol; caution is advised for concurrent use. During the course of this medication, it is important to follow the doctor's instructions for regular blood tests and periodic checks on health status.

• 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 sealed container to avoid exposure to air and moisture, preferably in a cool place below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle