Beaquel Tablets 200 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 treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 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 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 the individual patient's clinical response and drug 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, 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 at 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 medicine, clinical trials indicate that the dose may be reduced to as low as 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 for 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 treatment. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, especially at the start of treatment. Elderly patients should start with 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 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 with 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behaviors in young patients with major depressive disorder or other psychiatric conditions; therefore, careful judgment is necessary when administering, particularly in children, adolescents, and young adults. During usage, blood glucose levels may rise, so diabetic patients or patients with risk factors for diabetes should regularly monitor blood glucose and closely observe symptoms. Rare but serious side effects such as neuroleptic malignant syndrome can occur; if symptoms such as high fever, muscle rigidity, or changes in mental status arise, immediate medical attention is required. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, necessitating dosage adjustment or discontinuation if these symptoms arise. In elderly patients with dementia, this medication may increase the risk of mortality; thus, use should be avoided or administered very carefully. This drug may induce severe neutropenia and agranulocytosis, hence regular blood tests to check white blood cell counts are necessary, and immediate treatment should be sought upon infection symptoms. Caution is needed when administering to patients at risk for cerebrovascular disease, as the risk of stroke may increase. The risk of venous thromboembolism exists, so patients with thrombotic risk factors should closely monitor their condition before and after using this medication. Patients with cardiovascular diseases or hypotension may experience blood pressure changes such as orthostatic hypotension, and should be carefully monitored while slowly adjusting the dosage. There is a risk of serious skin adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Discontinuation of the medication is warranted immediately upon emergence of symptoms like rash, fever, or lymphadenopathy. This medication should not be administered to specific patients and should be used cautiously in those with hepatic impairment, cardiovascular diseases, seizure disorders, elderly patients, and pregnant women. Drowsiness, dizziness, dry mouth, weight gain, blood glucose and lipid abnormalities may occur; monitoring symptoms and adjustments as necessary is advised. This medication affects the central nervous system; caution is advisable during driving or operating machinery, and even more so when combined with alcohol or other central nervous system depressants. Women who are pregnant or breastfeeding should consult a physician before use, as it may affect the fetus or newborn. In case of overdose, serious side effects may occur, so strict adherence to prescribed dosages is essential, and immediate medical attention should be sought if in doubt. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

• 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 contact with air or moisture and is best kept at a cool temperature below 30 degrees. Proper storage will help maintain the efficacy of the medication.

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle