Quetiapine Tablets 300mg (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

Safety and efficacy in children and adolescents have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so healthcare professionals should carefully assess before prescribing and patients and caregivers should carefully monitor for changes in behavior during treatment. This medication may elevate blood sugar levels; therefore, diabetic patients or those at risk for hyperglycemia should regularly monitor blood sugar levels and closely observe symptoms of hyperglycemia such as thirst or frequent urination. This medication can rarely cause a serious side effect called Neuroleptic Malignant Syndrome, characterized by high fever, muscle rigidity, and altered consciousness, requiring immediate discontinuation of the drug and consultation with healthcare professionals if such symptoms occur. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia; thus, dosage adjustments or discontinuation should be considered if abnormal symptoms appear. In elderly patients with dementia, the risk of death may increase, so use in such patients should be avoided or approached with special caution. This medication may cause blood dyscrasias such as severe neutropenia or agranulocytosis; white blood cell counts should be monitored regularly, and if symptoms of infection develop, immediate consultation with healthcare professionals is necessary. Caution should be exercised in patients with a risk of cerebrovascular diseases due to the potential increase in stroke risk. The risk of venous thromboembolism necessitates careful monitoring and preventive measures for patients with thrombotic risk factors before and after administration. Patients with cardiovascular diseases or hypotension should be cautious as this medication can induce orthostatic hypotension, especially during initial dosage adjustments. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis can occur, and if rashes or skin changes arise, medication should be discontinued immediately. This medication should not be administered to particular patients, for example, those in a comatose state, those receiving central nervous system depressants, those undergoing epinephrine treatment, diabetic patients, and those with lactose intolerance. Patients with impaired liver function, cardiovascular diseases, a history of seizures, elderly patients, pregnant and breastfeeding women should start at a lower dosage and be closely monitored. Abrupt discontinuation of this medication may result in withdrawal symptoms, so the dosage should be gradually reduced, avoiding sudden discontinuation. This medication may cause central nervous system side effects such as drowsiness or dizziness, caution is advised when driving or operating hazardous machinery. There may be interactions with other medications; therefore, patients must inform their healthcare provider or pharmacist of any medications they are currently taking.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglycerides
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle