Quetiapine Tablets 25mg (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 the dose to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to the clinical response and tolerability of each patient. 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, in increments of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to the clinical response and tolerability of each patient; 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. (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 during acute treatment of bipolar disorder should continue 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 in elderly patients, particularly at the start of treatment. Initiate treatment in elderly patients at 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: The clearance of quetiapine after oral administration is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, initiate treatment at 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 is primarily used for the treatment of psychiatric disorders, specifically helping to alleviate symptoms of depression, schizophrenia, and bipolar disorder. When taking this medication, there is an increased risk of suicidal thoughts or behaviors in certain age groups, particularly in pediatric, adolescent, and young adult patients, necessitating careful judgment and continuous monitoring by a physician. Patients with diabetes or problems controlling blood sugar should regularly monitor blood glucose levels, as this medication may worsen blood sugar levels. They should consult their doctor. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, and if symptoms such as high fever, muscle rigidity, or changes in mental state occur, medical personnel should be notified immediately. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so patients should discuss any unusual movements or discomfort with their physician. Elderly patients with dementia may have an increased risk of death when using this medication, hence special caution is warranted. Severe agranulocytosis or neutropenia may occur, so if symptoms of infection or fever arise, patients should contact medical personnel immediately. Patients with cardiovascular disease or cerebrovascular disease should be cautious due to the risk of orthostatic hypotension or thrombosis with this medication, especially during the initial phases of treatment. Severe skin reactions may rarely occur; thus, if there is severe rash, fever, or lymph node swelling, patients should stop taking the medication and inform their doctor immediately. This medication is contraindicated for specific patients, such as those allergic to this drug or its components, in a coma, on central nervous system depressants, receiving epinephrine, or patients with diabetes. Patients with impaired liver function, cardiovascular disease, the elderly, or those at risk of suicide should have their dose adjusted and be closely monitored when this medication is administered. Common side effects include drowsiness, dizziness, dry mouth, weight gain, and these should be discussed with a physician if severe. Pregnant or breastfeeding women should consult a doctor before taking this medication due to potential impacts on the fetus or newborn. This medication may cause withdrawal symptoms or symptom exacerbation when suddenly discontinued; therefore, doses should be gradually reduced under medical guidance during discontinuation. Caution is advised when driving or operating machinery, and taking this medication alongside alcohol or central nervous system depressants may significantly enhance drowsiness or impaired concentration. Due to numerous drug interactions, patients taking other medications should inform their doctor or pharmacist, especially when administered with potent liver enzyme inhibitors or inducers, necessitating dose adjustments.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• elevated triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• reduced hemoglobin
• extrapyramidal symptoms

This medication should be stored in a tightly closed container to prevent air or moisture ingress and should be kept in a cool place below 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication for an extended period.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle