Beaquel Tablets 300 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, adjust to the usual effective daily dose of 300～400 mg. Depending on the individual patient's clinical response and 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. When used 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, in increments of no more than 200mg per day. Depending on the individual patient's clinical response and 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 with both 300 mg and 600 mg, but there was no additional benefit at 600 mg. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trial data indicate that in patients who tolerate the medicine, 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 therapy. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. In elderly patients, start with 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 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. In patients with renal or hepatic impairment, start treatment with this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

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

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses, so consultation with a doctor is essential before use and careful observation is required. While taking this drug, blood sugar may increase, or diabetes can worsen; therefore, patients with diabetes or those at risk of diabetes should regularly monitor their blood sugar levels and notify their doctor immediately if any abnormal symptoms arise. A serious side effect known as Neuroleptic Malignant Syndrome may rarely occur; thus, if symptoms such as high fever, muscle rigidity, or changes in mental state appear, discontinue the medication immediately and visit a hospital. Long-term use may cause movement disorders, such as extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms occur, dosage adjustment or discontinuation of the medication should be considered. It is not recommended to use this medication in elderly patients with dementia as it may increase the risk of mortality. Severe neutropenia or agranulocytosis may occur, so regular white blood cell count tests should be conducted, and any signs of infection should be reported to medical personnel immediately. Patients at risk of cerebrovascular disease should be cautious as the risk of stroke may increase during the use of this medication. There is a risk of venous thromboembolism, so patients with thromboembolic risk factors should be closely monitored before and after administration and preventive measures should be taken if necessary. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension when taking this medication, so they should rise slowly or be cautious when experiencing dizziness. If severe skin rash, fever, lymphadenopathy, or other severe skin adverse reactions occur, discontinuation of the medication and a visit to a medical institution is necessary. Caution is advised when using this medication alongside other central nervous system depressants or alcohol, as it may significantly increase drowsiness or decrease concentration. Pregnant or breastfeeding women should consult a doctor before use as it may affect the fetus or newborn, and refrain from use if necessary. Safety and efficacy in children and adolescents have not been established, so its use should be avoided. Elderly patients may have elevated blood levels, so it is advised to start with a low dose and monitor their condition closely; if dizziness or hypotension occur, they should notify immediately. In cases of overdose, severe drowsiness, hypotension, and tachycardia may occur, so it is crucial to adhere strictly to the dosage and seek medical help immediately if suspicion arises. This medication should be kept out of reach of children, and it is safer not to transfer it to other containers.

• 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 prevent exposure to air or humidity, and it should be kept in a cool place at or below 30 degrees Celsius to maintain its efficacy.

Appearance

White rectangular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle