Beaquel Tablets 100 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 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.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so caution is necessary. All age groups should be carefully monitored for suicidal tendencies or abnormal behavioral changes after starting treatment, and family members or caregivers should closely observe the patient. This medication may exacerbate hyperglycemia and diabetes, so patients with diabetes or risk factors should regularly check their blood sugar and consult with healthcare providers immediately if symptoms of hyperglycemia occur. Neuroleptic malignant syndrome, a serious side effect, may rarely occur, so if symptoms such as high fever, muscle rigidity, or changes in mental state appear, use should be discontinued immediately, and treatment should be sought. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so if symptoms occur, dose adjustment or discontinuation should be considered. In elderly patients with dementia, this medication may increase the risk of death, so it should be avoided or used very cautiously. Severe neutropenia or agranulocytosis may occur, so regular monitoring of white blood cell counts is necessary, and immediate treatment should be initiated if there are signs of infection. Patients at risk of cerebrovascular disease may experience an increased risk of stroke with this medication, so caution is necessary. There is a risk of venous thromboembolism, so patients with thrombotic risk factors should be closely monitored before and after use. Patients with cardiovascular diseases or hypotension may experience side effects such as orthostatic hypotension, so starting with a low dose and gradually increasing it is recommended. Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur, so if symptoms like rash, skin peeling, or fever occur, discontinuation of the medication should be immediate. This medication should not be administered to patients with hypersensitivity, in coma, those taking specific central nervous system depressants, those using epinephrine, diabetic patients, or lactose intolerant patients. Caution must be taken with administration to patients with liver dysfunction, cardiovascular diseases, history of seizures, elderly patients, patients at risk for suicide, pregnant or breastfeeding women, and their conditions should be closely monitored. This medication may cause various side effects such as drowsiness, dizziness, dry mouth, weight gain, abnormal blood lipid levels, extrapyramidal symptoms, and so if any unusual symptoms occur, consultation with healthcare providers is necessary. During discontinuation, do not stop suddenly; gradually reduce the dose, as acute withdrawal symptoms may occur, requiring attention. Drowsiness and decreased concentration may occur while driving or operating hazardous machinery, so caution is required. This medication may enhance the effects of other central nervous system depressants or alcohol, so caution is advised when used concomitantly. When administered to pregnant women, it may affect the fetus, so a careful decision should be made after consultation with a doctor, and breastfeeding women are advised to avoid nursing. In the case of overdose, severe drowsiness, hypotension, tachycardia, etc., may occur, and since there is no specific antidote, appropriate treatment should be sought immediately at a medical institution. This medication should be kept out of reach of children and should not be transferred to other containers.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• elevated total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it should be kept in a cool place below 30 degrees Celsius to maintain the effectiveness of the medication.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle