Quetiapine Tablets 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This drug is taken 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 daily. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 150～750 mg/day. 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: This drug is taken twice daily, with or without food. As monotherapy or 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, with increases of no more than 200mg per day. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depressive episodes associated with bipolar disorder: Adults: This drug is taken once daily at bedtime, with or without food. The total daily dose 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 drug, 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 drug, 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. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults As with other antipsychotics, this drug should be administered with caution to older adults, particularly when starting treatment. Older patients should start this drug at 25 mg/day, with gradual increases of 25～50 mg per day; the effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment After oral administration of quetiapine, clearance 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 in patients with known hepatic impairment. Patients with renal or hepatic impairment should start this drug at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

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

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, thus careful evaluation by a physician and close monitoring of the patient and their guardians are necessary when using this drug. This medication may cause elevated blood glucose levels leading to diabetes or diabetes-related complications in some patients; therefore, patients with diabetes or those at risk for diabetes should check their blood glucose levels regularly. Rarely, this medication can cause a serious side effect known as Neuroleptic Malignant Syndrome, so if symptoms like high fever, muscle rigidity, or changes in mental status occur, immediate medical attention should be sought. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, and if such symptoms occur, considerations for dose adjustment or discontinuation of treatment should be made. In elderly patients with dementia, the use of this drug may increase the risk of death, hence special caution is required. This medication can lead to hematological adverse reactions such as severe neutropenia and agranulocytosis, so regular monitoring of white blood cell counts and prompt treatment if infection symptoms occur is essential. In patients with a risk of cerebrovascular disease, the use of this drug may increase the risk of stroke, hence careful use is necessary. Due to the risk of venous thromboembolism, patients with risk factors for thrombosis should be closely monitored before and after administration. Patients with cardiovascular disease or hypotension should be aware that this drug may induce orthostatic hypotension, especially during dose adjustments initially. Serious skin adverse reactions may occur, so if symptoms like skin rash, fever, or lymph node swelling develop, the medication should be discontinued immediately and medical advice sought. This drug should not be used in patients with specific diseases or conditions, such as comatose state, lactose intolerance, or diabetes. Patients with impaired liver function, elderly patients, those at risk for suicide, pregnant women, and nursing mothers should use this drug with caution and under strict medical guidance. Sudden discontinuation of the drug may cause withdrawal symptoms or worsening of symptoms, therefore gradual tapering is safer. This medication can cause various side effects such as drowsiness, dizziness, and dry mouth; caution is advised when driving or operating machinery. When combined with other central nervous system depressants or specific medications, the risk of side effects may increase due to interactions, hence it is essential to inform the doctor or pharmacist of any other medications being taken. Women who are pregnant or may become pregnant should carefully consider whether to use this drug as it may affect the fetus, and it is advisable to avoid taking the drug while breastfeeding.

• 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. Storing it this way will help maintain the medication's efficacy over time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle