Hanwha 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 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. 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, with or without food. Whether 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 200 mg 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 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, dose reduction to as low as 200 mg has been reported in clinical trials. (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 continue on the same dose. The dose may be adjusted within 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 As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Start treatment 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 Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start treatment at 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 medicine have not been established in children and adolescents.

This drug may have suicidal tendencies, so careful monitoring is necessary, especially when administered to children, adolescents, and young adults. Blood sugar levels may rise while taking this medication, so patients with diabetes or those at risk of elevated blood sugar should have regular blood sugar tests. A serious side effect called Neuroleptic Malignant Syndrome may occur, so immediate consultation with healthcare professionals is required if symptoms such as high fever, muscle rigidity, or changes in consciousness arise. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so patients should consult a doctor if any abnormal symptoms occur. This medication can increase the risk of death in elderly patients with dementia, so caution is required in its use. Blood disorders such as agranulocytosis and neutropenia can rarely occur, so if fever or signs of infection are present, healthcare professionals should be notified immediately. There may be an increased risk of cerebrovascular disease, so patients with risk factors for stroke should exercise special caution. There is a risk of venous thrombosis; preventive measures should be taken for patients with risk factors for thrombosis, and care should be sought immediately if symptoms appear. Patients with cardiovascular disease or hypotension may experience dizziness or orthostatic hypotension while taking this medication, so caution is advised. Severe skin reactions may occur; if symptoms such as skin rashes, fever, or lymphadenopathy appear, stop taking the medication immediately and consult a physician. This medication should not be given to patients with allergies to specific ingredients, those in a coma, those taking central nervous system depressants, those receiving epinephrine, or patients with diabetes. Patients with impaired liver function should start with a low dose and be monitored closely, and pregnant or nursing women should be cautious when taking this medication. Common side effects such as drowsiness, dizziness, dry mouth, weight gain, and blood lipid abnormalities may occur, so caution is advised. In the case of overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may appear, and since there is no specific antidote, appropriate treatment should be sought at a medical facility immediately. Caution should be exercised during driving or the operation of dangerous machinery while taking this medication, and extra care should be taken if used with other central nervous system depressants or alcohol.

• 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 sealed container to prevent air or moisture from entering, and it is best to store it at a cool temperature below 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle