Quetiapine Tablets 300 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 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 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

The safety and efficacy in pediatric and adolescent populations have not been established.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, so careful observation is necessary during administration. This drug can increase blood sugar levels in some patients, potentially worsening diabetes symptoms; hence, patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar levels. Neuroleptic malignant syndrome may occur during treatment, characterized by severe muscle rigidity, high fever, or changes in mental status, and if such symptoms appear, immediate consultation with a healthcare professional is necessary. Prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia, such as involuntary movements of the face or body; thus, consultation with a doctor is required upon the appearance of abnormal symptoms. Elderly patients with dementia may be at increased risk of death when using this drug, necessitating special caution. This medication can cause significant neutropenia or agranulocytosis, so attention to infection symptoms and regular blood tests are required. Patients with a risk of cerebrovascular disease may have an increased risk of stroke when using this drug, requiring careful administration. Due to the risk of thrombosis, patients with risk factors for thrombosis should be monitored closely and take preventive measures before and after using this drug. Patients with cardiovascular diseases or hypotension may experience dizziness or orthostatic hypotension upon taking this drug, necessitating careful dosage adjustment and observation. This drug may cause serious skin reactions; thus, if symptoms like skin rash, fever, or lymph node swelling occur, immediate discontinuation and notification to a healthcare professional is required. This drug should not be administered to patients with certain genetic lactose intolerance, to patients in a comatose state, or to patients taking central nervous system depressants or receiving epinephrine. Patients with impaired liver function may experience increased blood concentration of this drug; therefore, treatment should start at a lower dose and be gradually increased. Pregnant or nursing mothers should avoid taking this drug without strict medical judgment, as it may affect the fetus or newborn; nursing mothers are advised against breastfeeding while on this drug. Common side effects include drowsiness, dizziness, dry mouth, and weight gain, so caution is advised when driving or operating dangerous machinery. Sudden discontinuation may lead to withdrawal symptoms, so the dose should be gradually reduced according to a doctor's instructions. This drug may exacerbate side effects when taken with other central nervous system depressants or alcohol, requiring caution during concurrent use. In case of overdose, as there is no specific antidote, immediate intensive care and observation in a medical institution is necessary.

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

This medication may be sensitive to air or moisture and should be stored in a sealed container. Additionally, it is important to keep it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

White, oblong, film-coated tablet

Package unit

[For domestic use] 30 tablets/bottle, 100 tablets/bottle [For export] 30 tablets (10 tablets/PTP x 3)