Seroquel Tablets 100mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine twice daily, regardless of meals. 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 dose of 300～400 mg daily. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and tolerability. 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: Take this medicine twice daily, regardless of meals. As monotherapy or as adjunctive therapy with 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. 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, regardless of meals. 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 therapeutic 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. Clinical trials showed that the dose could 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 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 lowest effective dose for maintenance therapy. 3. Older adults: As with other antipsychotics, this medicine should be administered with caution to older adults, particularly at the start of treatment. Initiate treatment in older patients with 25 mg/day and gradually increase by 25～50 mg per day; the effective dose in older adults may be lower than in younger patients. 5. Patients with renal or hepatic impairment: Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, initiate treatment with 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

4. Children and adolescents: The safety and efficacy of this drug 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 psychiatric conditions, so the prescribing physician must exercise caution, and both the patient and family must observe carefully. Blood sugar levels may rise during the use of this medication; therefore, diabetic patients or those with risk factors should regularly monitor their blood sugar levels and observe for symptoms of hyperglycemia. Rarely, severe neuroleptic malignant syndrome may occur, presenting with high fever, muscle rigidity, and altered mental status; if these symptoms occur, medical attention should be sought immediately. Long-term use may lead to tardive dyskinesia, which involves involuntary movements of the mouth, face, and body, so dosage adjustment or discontinuation should be considered if symptoms appear. The use of this medication is not recommended in elderly patients with dementia due to an increased risk of death. Severe agranulocytosis or neutropenia may occur, necessitating regular monitoring of white blood cell counts and immediate treatment if symptoms of infection arise. Patients at risk for cerebrovascular diseases may have an increased risk of stroke and should use this medication cautiously. There is a risk of venous thromboembolism; therefore, patients with risk factors for thrombosis should be assessed before and during therapy and take preventive measures. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension, especially during initial dosing, so blood pressure and symptoms should be closely monitored. This medication may cause severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions, so if widespread skin rashes or fever develop, the medication should be stopped immediately and a doctor consulted. Patients with hypersensitivity to this medication or its components, those in a coma, or those taking certain central nervous system depressants, patients receiving epinephrine, diabetic patients, lactose intolerant patients, etc., should not take this medication. Patients with liver dysfunction should start at a low dose and gradually increase while monitoring their condition. Pregnant or breastfeeding women should consult their doctor before use as it may affect the fetus or newborn, and it is recommended to avoid breastfeeding while taking this medication. This medication may cause drowsiness, dizziness, and decreased attention; caution is advised when driving or operating dangerous machinery. There may be drug interactions, particularly with central nervous system depressants, antifungals, certain antibiotics, and antidepressants, so inform your doctor if taking these, and avoid grapefruit juice. When discontinuing the medication, do not do so abruptly; instead, taper off gradually over 1-2 weeks, as acute withdrawal symptoms or exacerbation of symptoms may occur. In the case of overdose, there is no specific antidote, so appropriate treatment must be sought immediately at a medical facility, and intensive management may be necessary depending on symptoms.

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

This medication may be sensitive to air or moisture; therefore, it is important to store it in a tightly closed container. Additionally, to maintain the drug's effectiveness, it should be stored in a cool place below 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (10 tablets/PTP x 3)