Quetiapine Tablets 50 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This product 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 individual patient's clinical response and tolerability, the dose may be adjusted within 150～750 mg/day. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder Adults: This product 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 200mg per day. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder Adults: This product 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 product, 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, reduction to as low as 200 mg has been shown to be possible in clinical trials. 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 clinical response and individual tolerability, the twice-daily dose may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. Elderly patients As with other antipsychotics, this product should be administered with caution to elderly patients, especially at the start of treatment. Elderly patients should start at 25 mg/day and have their dose gradually increased by 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment Clearance after oral administration of quetiapine 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 to patients with known hepatic impairment. Patients with renal or hepatic impairment should start at 25 mg/day and have their dose gradually increased by 25～50 mg per day to the effective dose.

This medication is used to treat psychiatric disorders and may increase the risk of suicidal thoughts and behaviors, especially in young patients aged 18 to 24, so they require careful judgment and continuous monitoring by a doctor. Blood sugar may increase during treatment with this medication, and patients with diabetes or those at risk for diabetes should regularly check their blood sugar and monitor symptoms carefully. Neuroleptic Malignant Syndrome, characterized by severe muscle rigidity, high fever, and irregular pulse, can rarely occur; if such symptoms appear, immediate medical attention is required. Prolonged use may lead to tardive dyskinesia, a condition characterized by involuntary movements of the face or body, so if symptoms appear, consult a doctor. In elderly patients with dementia, the use of this medication may increase the risk of death, so caution is necessary. Severe neutropenia or agranulocytosis, indicated by a decrease in white blood cell count, may occur, so if there are symptoms of infection or fever, notify healthcare professionals immediately. Patients with a risk of cerebrovascular disease require special attention during the use of this medication as the risk of stroke may increase. As there is a risk of thrombosis, patients with risk factors for thrombosis should be carefully monitored before and during the use of this medication. Patients with cardiovascular disease or hypotension may experience dizziness or orthostatic hypotension symptoms, especially during initial dosage adjustments, so caution is advised. This medication may rarely cause serious skin reactions; if extensive skin rashes, fever, or lymph node swelling occur, discontinue use immediately and consult a doctor. Patients with hypersensitivity to this medication, those in a coma, and those using specific central nervous system depressants, patients receiving epinephrine, diabetic patients, lactose intolerant patients, should not take this medication. Patients with impaired liver function, cardiovascular disease, a history of seizures, elderly patients, and women who are pregnant or breastfeeding should take this medication with caution. Common symptoms during treatment may include drowsiness, dizziness, dry mouth, weight gain, and blood lipid abnormalities, so these symptoms should be discussed with healthcare professionals. This medication can cause drowsiness and decreased alertness, necessitating caution when driving or operating dangerous machinery. In the case of overdose, there is no specific antidote, so prompt medical treatment and intensive monitoring are required. This medication should be kept out of reach of children, and transferring it to another container should be avoided.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, avoid storing it in extremely hot or cold locations, and it is best to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle