Quetiapine Tablets 300 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medication 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 daily dose of 300–400 mg. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 150–750 mg/day. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medication 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, in increments of no more than 200 mg per day. Depending on the clinical response and tolerability of each patient, 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: This medication is taken 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 medication, 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medication, 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 300–800 mg/day, administered twice daily. It is important to use the lowest effective dose for maintenance therapy. 3. Older adults : As with other antipsychotic drugs, this medication should be administered with caution in older adults, particularly when treatment is initiated. Older patients should start with 25 mg/day and have their dose gradually increased by 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 : Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because 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 with 25 mg/day and have their dose gradually increased by 25–50 mg per day until the effective dose is reached.

This medication can increase the risk of suicidal thoughts or behaviors in young people with major depressive disorder or psychiatric illnesses, so doctors should carefully assess the risks and benefits before prescribing. During treatment with this medication, blood sugar levels may rise, and symptoms of diabetes or hyperglycemia may appear, so patients with diabetes or risk factors should regularly monitor their blood sugar and observe symptoms. There is a rare but serious side effect known as neuroleptic malignant syndrome, so if symptoms such as high fever, muscle stiffness, or changes in mental state occur, contact a doctor immediately. Prolonged use may lead to extrapyramidal symptoms and tardive dyskinesia, so if abnormal movement symptoms appear, dosage adjustment or discontinuation should be considered. In elderly patients with dementia, using this medication may increase the risk of death, so it should be avoided or used with extreme caution in this age group. Severe neutropenia or agranulocytosis may occur, so if the white blood cell count decreases, this medication should be discontinued and signs of infection should be closely monitored. Patients at risk of cerebrovascular disease may have an increased risk of stroke while taking this medication, so care should be taken. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should check for hazards and take preventative measures before use. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension while taking this medication, so the initial dose should be started low, and their condition should be closely monitored. This medication can cause serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), so if symptoms such as skin rash or fever occur, use should be stopped immediately. This medication should not be given to patients with hypersensitivity to specific components, those in a coma, those taking central nervous system depressants, those receiving epinephrine, diabetic patients, and patients with lactose intolerance. Patients with impaired liver function may experience decreased metabolism of this medication, leading to elevated blood concentrations, so they should start at a low dose and gradually increase. Pregnant or breastfeeding women should only take this medication if necessary, as it may affect the fetus or newborn, and it is advisable to avoid use while breastfeeding. This medication may cause central nervous system side effects such as drowsiness and dizziness, so caution is needed when driving or operating dangerous machinery. Sudden discontinuation of this medication can lead to withdrawal symptoms or worsening of symptoms, so the dosage should be gradually reduced over 1-2 weeks. This medication can interact with various drugs; therefore, if other medications are being taken, it is essential to consult a doctor or pharmacist. In cases of overdose, there is no specific antidote, so seek immediate medical attention for appropriate treatment; patients with cardiovascular disease may be particularly at risk. This medication is not recommended for children and adolescents as safety and efficacy have not been established in this population. Elderly patients have slower drug metabolism and a higher risk of side effects, so treatment should start at a low dose and patients should be closely monitored during dose adjustments.

• 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 closed container to prevent air or moisture from entering. It is also important to store it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

White, rectangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3), 30 tablets/bottle, 200 tablets/bottle