Quroquel Tablet 50 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medicine 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, the dose should be adjusted 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 the range of 150～750 mg/day. Maintenance treatment has not been evaluated in adult patients with schizophrenia. Patients should be regularly reassessed to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medicine is taken twice daily, with or without food. As monotherapy or as adjunctive therapy with 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 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 medicine 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 pivotal clinical trials of this medicine, 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. Clinical trials indicate that patients who tolerate the medicine may have their dose 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 each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance treatment. 3. Elderly patients: As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start at 25 mg/day, with gradual increases of 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment: The oral clearance 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, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

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

This medication is primarily used for the treatment of psychiatric disorders, and its safety has not been established in pediatric and adolescent populations, so its use is not recommended. During treatment with this medication, there may be an increase in suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, who require close monitoring by a physician. There is a risk of increased blood glucose levels; therefore, diabetic patients or those at risk for hyperglycemia should regularly check and manage their blood glucose. Serious side effects known as neuroleptic malignant syndrome may occur, and patients should immediately inform healthcare providers if they experience symptoms such as high fever, muscle rigidity, or altered consciousness. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, and if such symptoms occur, consideration should be given to dosage adjustment or discontinuation of the medication. Elderly patients with dementia may have an increased risk of mortality, necessitating careful use of this medication. Blood dyscrasias such as agranulocytosis or neutropenia may occur, warranting immediate medical attention if there are symptoms of infection or fever. Patients at risk for cerebrovascular disease or thrombosis should consult a doctor before taking this medication and should be closely monitored for thrombosis symptoms. Patients with cardiovascular disease or hypotension should be cautious as this medication may cause dizziness or orthostatic hypotension. This medication may cause serious skin reactions such as severe rashes, fever, or lymphadenopathy, and if such symptoms arise, the medication should be stopped immediately and healthcare providers informed. Patients with hypersensitivity, coma, or certain genetic lactose intolerance should not take this medication. Patients with impaired liver function should start on a low dose and gradually increase the dosage while regularly monitoring the patient's condition. Women who are pregnant or breastfeeding should fully consult with their physician before taking this medication, as there may be side effects for the fetus or newborn. This medication may cause drowsiness or dizziness; therefore, caution is required when driving or operating hazardous machinery. There may be interactions with other medications during treatment, so all medications being taken should be disclosed to a physician or pharmacist, particularly in combination with certain antifungals, antibiotics, or antidepressants. Abrupt discontinuation of this medication may lead to withdrawal symptoms, so if treatment needs to be stopped, it should be done gradually under a physician's guidance. Overdose may result in severe side effects, so adherence to the prescribed dosage is critical, and immediate medical treatment should be sought in the event of an overdose. This medication should be stored out of reach of children and should not be transferred to another container.

• 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 protect it from exposure to air and moisture, and it is important to maintain a temperature below 30 degrees Celsius. Therefore, it is advisable to store it in a cool place away from direct sunlight.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle