Qutimad 100mg (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

Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents.

This medication is an atypical antipsychotic primarily used for the treatment of various mental illnesses such as schizophrenia, bipolar disorder, and major depressive disorder. The safety and efficacy of this medication in children and adolescents have not been established; hence, its use is not recommended in these populations. During treatment, the risk of suicidal thoughts or behaviors may increase in some young patients, so both the patient and caregivers should carefully monitor for changes in symptoms. Blood sugar may rise, worsening symptoms of diabetes, so diabetic patients or patients with risk factors for diabetes should regularly monitor and manage blood sugar levels. This medication can cause a rare but serious side effect known as neuroleptic malignant syndrome; hence, if symptoms such as high fever, muscle rigidity, or mental status changes occur, immediate consultation with medical personnel is required. Long-term use may result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia; therefore, patients should consult a doctor if they exhibit unusual symptoms. Elderly patients with dementia may face an increased risk of death when using this medication, so it should be administered cautiously. This medication can induce severe neutropenia and agranulocytosis; thus, regular monitoring of white blood cell counts is necessary, and any signs of infection should be reported to medical staff immediately. Patients with cardiovascular disease or hypotension may experience side effects such as orthostatic hypotension, especially during the initial stages of treatment, so extra caution is necessary. This medication can affect the central nervous system, leading to drowsiness and dizziness; therefore, caution is needed when driving or operating hazardous machinery. Pregnant women or women who may become pregnant, as well as nursing mothers, should consult a doctor before taking this medication, and nursing is advised against while on this medication. This medication should not be given to patients with allergies to specific ingredients or in a coma, nor to those currently taking particular medications; close monitoring and dosage adjustments are required in patients with liver dysfunction or the elderly. In cases of overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may occur, and because there is no specific antidote, immediate medical intervention is needed. While taking this medication, various side effects such as constipation, dry mouth, weight gain, changes in blood lipid levels may occur, and if any unusual symptoms persist or worsen, consultation with medical personnel is recommended. The risk of side effects may increase when taken with other central nervous system medications or alcohol, so caution is advised when combining treatments.

• 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 against air and moisture, and kept in a cool place below 30 degrees Celsius for safe use.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle