Quetiapine Tablets 25 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 dose of 300～400 mg/day. The dose may be adjusted within the range of 150～750 mg/day according to each patient’s clinical response and drug tolerability. - Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine whether maintenance therapy is needed. 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 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 200mg/day. Depending on each patient’s clinical response and drug tolerability, the dose may be adjusted within the range of 200～800 mg/day; 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 pivotal 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. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, dose reduction to a minimum of 200 mg has been shown to be possible 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient’s tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered in 2 divided doses. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults: As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start at 25 mg/day, with gradual increases of 25～50 mg/day; the effective dose in older adults 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. Since quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Patients with renal or hepatic impairment should start at 25 mg/day, with gradual increases of 25～50 mg/day until an effective dose is reached.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors in young people with depression or psychiatric disorders, so doctors should carefully assess the need for treatment versus the risks involved. All patients should be closely monitored for changes in symptoms or suicidal tendencies after starting treatment, and families and caregivers should be instructed to watch over the patient closely. This medication can increase the risk of hyperglycemia and diabetes, so patients with a history of diabetes or risk factors should regularly check their blood sugar and be vigilant for symptoms of high blood sugar. There is a risk of a rare but serious side effect called neuroleptic malignant syndrome, so if symptoms such as high fever, muscle stiffness, or changes in mental state occur, immediate medical attention should be sought. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so if any abnormal symptoms appear, consideration should be given to dosage adjustment or discontinuation. Elderly patients with dementia may be at increased risk of mortality, so this medication is not recommended for the treatment of dementia-related psychosis. There may be a decrease in blood cell counts, particularly severe neutropenia and agranulocytosis, so blood tests should be performed regularly to check white blood cell counts, and immediate action should be taken if there are signs of infection. The risk of cerebrovascular disease may be increased, so special caution is needed for patients with stroke risk factors. There is a risk of venous thromboembolism, so patients with factors for thromboembolism should be monitored carefully both before and during treatment. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension with the use of this medication, so they should be monitored closely. Severe skin adverse reactions may rarely occur, so if symptoms such as rashes, fever, or lymphadenopathy appear, it is important to stop taking the medication immediately and consult a physician. This medication should not be administered to specific patients, such as those who are allergic to its components or are in a comatose state, or to diabetic patients. Patients with liver or cardiovascular disease, those with a history of seizures, the elderly, or pregnant women should start with a lower dose and adjust the dose upwards while monitoring closely. Various side effects such as drowsiness, dizziness, dry mouth, weight gain, etc. may occur during administration, so the doctor should be consulted if any abnormal symptoms arise. This medication may cause withdrawal symptoms or worsening of symptoms if abruptly discontinued, so it is important to gradually reduce the dosage when stopping. Use during pregnancy may result in withdrawal symptoms or movement disorders in newborns, so it should be used cautiously in pregnant women and avoided during breastfeeding. This medication acts on the central nervous system and may cause drowsiness or decreased concentration, so caution is advised when driving or operating dangerous machinery. There are many potential drug interactions, so patients must inform their doctor or pharmacist about any other medications they are taking, and particularly must not use it in conjunction with epinephrine or strong liver enzyme inducers. Overdosage may result in serious hypotension, sedation, and similar symptoms, and since there is no specific antidote, immediate medical attention is required. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

• 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 avoid exposure to air or moisture, and it is advisable to keep it in a cool place below 30 degrees.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle