Cutiema 300 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. 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, with increases 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, 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trials indicate that the dose may be reduced to a minimum of 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 be maintained 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 minimum 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 elderly patients on 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 : Clearance after oral administration 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. Start patients with renal or hepatic impairment on 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 medication should be used cautiously in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses, as it may increase the risk of suicidal thoughts or behaviors. Patients' conditions should be closely monitored during the course of treatment, and family members or caregivers should also pay attention to any changes in the patient's behavior. This drug can raise blood sugar levels, therefore, patients with diabetes or those at risk for diabetes should regularly check their blood sugar, and if symptoms of high blood sugar such as increased thirst or frequent urination occur, they should consult a doctor immediately. A serious side effect known as neuroleptic malignant syndrome may rarely occur, presenting symptoms such as high fever, muscle rigidity, and changes in consciousness. If these symptoms occur, the medication should be discontinued immediately, and medical attention should be sought. Long-term use may result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia, and if any abnormal symptoms occur, dosage adjustments or discontinuation may be considered. In elderly patients with dementia, this medication may increase the risk of death, so caution is especially warranted. This drug can cause a decrease in blood cell counts, particularly neutropenia, so if symptoms of infection appear, healthcare personnel should be informed immediately, and regular blood tests to monitor the condition are important. Patients with a high risk of cerebrovascular diseases may experience an increased risk of stroke, necessitating careful use. There is also a risk of venous thromboembolism, so it is important to check for risk factors related to thrombosis and take preventive measures as necessary. Patients with cardiovascular diseases or hypotension should be particularly cautious, as symptoms such as dizziness or orthostatic hypotension can occur, especially during the initial dosage adjustment. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reactions may occur rarely, so if symptoms such as skin rashes, fever, or lymph node swelling appear, the medication should be discontinued immediately. This drug should not be administered to patients with hypersensitivity to any components, comatose patients, those taking strong central nervous system depressants, patients receiving epinephrine, diabetic patients, or those with lactose intolerance. Patients with impaired liver function, cardiovascular patients, those with a history of seizures, elderly patients, and women who are pregnant or breastfeeding should use this medication with caution. Given the potential for drug interactions, it is essential to inform the doctor or pharmacist if taking any other medications, particularly if taking strong liver enzyme inhibitors or inducers, as dosage adjustments may be required. Using this medication during pregnancy may result in withdrawal symptoms in newborns, so it should only be used after consulting a physician. It is advisable to avoid use while breastfeeding. Safety and effectiveness in children and adolescents have not been established, therefore its use is not recommended in this population. In case of overdose, symptoms such as severe drowsiness, hypotension, and heart issues may occur, and immediate emergency treatment is required, although there is no specific antidote. This drug may cause drowsiness and dizziness, thus caution is required when driving or operating hazardous machinery. Weight gain, changes in blood lipid levels, and blood sugar levels may occur while taking this medication, so regular health check-ups and lifestyle management are advised.

• 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. Additionally, it is advisable to keep it in a cool place below 30 degrees Celsius.

Appearance

White, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle