Donghwa Quetiapine Tablet 25 mg (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. 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. 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. Older adults: Start treatment with this medicine 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

The safety and efficacy of this medication have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, so careful observation is required. Blood sugar levels may rise during treatment, so patients with diabetes or those at risk for diabetes should regularly monitor their blood sugar levels. Rarely, a serious side effect known as neuroleptic malignant syndrome may occur, so if symptoms like high fever, muscle rigidity, or changes in mental state appear, you should inform medical personnel immediately. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so consult a physician if symptoms occur. The use of this medication is not recommended in elderly patients with dementia, as there may be an increased risk of death, requiring special attention. Severe agranulocytosis and aplastic anemia can occur, so if leukocyte counts are low, discontinue use and be vigilant for signs of infection. In patients at risk for cerebrovascular disease, the use of this medication may increase the risk of stroke, so it should be used cautiously. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be carefully monitored before and after use. Patients with cardiovascular diseases or hypotension should be cautious, as orthostatic hypotension may occur with this medication. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may rarely occur, so if symptoms such as skin rash or fever appear, discontinue use immediately and consult a physician. This medication should not be administered to patients with certain diseases or conditions, and it should be carefully administered in patients with liver disease, cardiovascular disease, seizure disorders, elderly individuals, and pregnant women. There are numerous drug interactions, so consult with a doctor or pharmacist before taking other medications, especially with central nervous system depressants, CYP3A4 inhibitors, and serotonergic drugs. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as it may affect the fetus or newborn. The safety and efficacy of this medication have not been established in children and adolescents, so it is advisable not to use it in these populations. In case of overdose, serious side effects may occur, so it is important to adhere to the prescribed dosage and, if unusual symptoms appear, visit a medical institution immediately. During treatment, drowsiness or dizziness may occur while driving or operating machinery, so caution is advised. When discontinuing treatment, do not stop abruptly but gradually reduce the dosage under medical supervision.

• 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 prevent air or moisture from entering, and it is best stored in a cool place below 30 degrees Celsius. This method of storage will help maintain the medication's effectiveness for a longer time.

Appearance

Pink, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle