Donghwa Quetiapine Tablet 100mg (Quetiapine Fumarate)

Adult dose

Schizophrenia - Adults: This medicine is taken 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 daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to the individual patient's clinical response and tolerability. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder - Adults: This medicine is taken twice daily, regardless of meals. As monotherapy or 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 the individual patient's clinical response and tolerability, and the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder - Adults: This medicine is taken 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 the confirmatory clinical trial 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trials have shown that the dose may be reduced to as low as 200 mg in patients who tolerate the medicine. 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. The dose administered twice daily may be adjusted within 300～800 mg/day according to clinical response and individual tolerability. It is important to use the lowest effective dose for maintenance therapy. Older adults: Start treatment at 25 mg/day and gradually increase by 25～50 mg daily. The effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment: Start treatment with this medicine at 25 mg/day and gradually increase by 25～50 mg daily 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 drug is primarily used to treat mental disorders and its safety and efficacy have not been established for children and adolescents so its use is not recommended. There may be an increased risk of suicidal thoughts or behavior during treatment, so close monitoring by a doctor and careful attention from family members are required, especially for young patients. As there is a risk of increased blood sugar or worsening of diabetes, individuals with diabetes or those with issues in blood sugar control should have regular blood tests and exercise caution. Rarely, neuroleptic malignant syndrome may occur, which can present with severe muscle rigidity, high fever, and autonomic nervous system abnormalities, so if such symptoms occur, inform healthcare professionals immediately. Long-term use may result in involuntary movements, and if abnormal symptoms appear, dosage adjustment or discontinuation should be considered. Elderly patients with dementia might face a higher risk of death with this medication, so special caution is necessary. Severe neutropenia or agranulocytosis may occur, leading to a rapid decrease in the number of white blood cells, so any signs of infection or fever should be discussed with a doctor immediately. Patients at risk of cardiovascular or cerebrovascular disease should be alert for hypotension or thrombosis upon administration of this drug, especially during initial dose adjustments when symptoms like dizziness or fainting may occur. Severe skin reactions have been reported infrequently; if symptoms like rash, fever, or lymphadenopathy occur, ingestion should be discontinued and healthcare professionals should be consulted immediately. Administering this medication with other central nervous system depressants or alcohol may significantly increase drowsiness and reduce concentration, hence caution is warranted. Women who are pregnant or may become pregnant need to carefully consider the risks to the fetus before taking this drug, and nursing mothers are advised to avoid it. In case of overdose, symptoms like drowsiness, low blood pressure, and increased heart rate may occur, and since there is no specific antidote, prompt medical management is necessary. Patients should be cautious while driving or operating dangerous machinery, and abrupt discontinuation can lead to withdrawal symptoms, so dosage should be tapered gradually under a doctor's guidance.

• 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 protect it from air and moisture, and it is best kept in a cool place at or below 30 degrees Celsius. Storing it this way can help maintain the medication's effectiveness for a longer time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle