Quroquel Controlled-Release Tablet 300 mg (Quetiapine Fumarate)

Adult dose

Administer this medication once daily in the evening. Swallow the tablet whole; do not split, chew, or crush it. Avoid taking this medication with food, or take it with a low-fat meal (approximately 300 calories). Schizophrenia Adults: Initiate treatment at 300 mg of quetiapine. Adjust the dose within the range of 400∼800 mg per day according to each patient's response and tolerability. The dose may be increased by up to 300 mg per day at intervals of 1 day. The safety of doses exceeding 800 mg per day has not been evaluated in clinical trials. Acute treatment of manic or mixed episodes associated with bipolar I disorder Adults: This medication may be used as monotherapy or as adjunctive therapy to lithium or valproate. Initiate treatment on Day 1 at 300 mg of quetiapine, increase to 600 mg on Day 2, and from Day 3 onward adjust the dose within the range of 400∼800 mg per day according to the individual patient's clinical response and tolerability. Recommended dosing schedule Day 1: 300 mg Day 2: 600 mg Day 3: 400∼800 mg Acute treatment of depressive episodes associated with bipolar disorder Adults: This medication is used as monotherapy. The daily dose should be 50 mg of quetiapine on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. Recommended dosing schedule Day 1: 50 mg Day 2: 100 mg Day 3: 200 mg Day 4: 300 mg Prevention of recurrence of bipolar disorder in patients who have responded to quetiapine treatment for manic, mixed, or depressive episodes Patients who responded to quetiapine during acute treatment of bipolar disorder should continue on the same dose to prevent recurrence of mania, mixed episodes, or depression associated with bipolar disorder. The dose may be adjusted within the range of 300∼800 mg per day according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. Adjunctive treatment of major depressive disorder Adults: Initiate treatment with 50 mg on Day 1 and increase to 150 mg on Day 3. The efficacy of this medication has been established at 150∼300 mg per day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg per day have not been studied. Switching from immediate-release tablets: Patients taking immediate-release quetiapine fumarate tablets may be switched to this medication for convenience of administration; it can be administered once daily at the same total daily dose. Individual dose adjustment may be required. Elderly patients: As with other antipsychotics, administer this medication with caution in elderly patients, particularly when initiating treatment. The dose should be increased gradually, and the therapeutic daily dose may be lower than that in adult patients. The mean plasma clearance of quetiapine may be reduced by 30∼50% in elderly patients compared with adult patients. Initiate treatment in elderly patients at 50 mg per day. Increase the dose by 50 mg per day until an effective dose is reached, according to each patient's clinical response and tolerability. Patients with renal impairment: After oral administration of this medication, mean oral clearance is reduced by 25% in patients with severe renal impairment (creatinine clearance 10∼30 mL/min/1.73 m2) compared with adult patients; however, dose adjustment is generally not required. Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, administer this medication with caution to patients with hepatic impairment, particularly when initiating treatment. Initiate treatment in patients with hepatic impairment at 50 mg per day and increase the dose by 50 mg per day until an effective dose is reached, according to each patient's clinical response and tolerability.

Child dose

Children and adolescents 18 years of age and younger: The safety and efficacy of this medication have not been established.

This medication is used for the treatment of psychiatric disorders, particularly effective for schizophrenia and bipolar disorder. There may be an increased risk of suicidal thoughts, especially in young patients aged 18 to 24, requiring careful supervision by a physician. Patients with diabetes or at risk of hyperglycemia should regularly monitor their blood glucose levels, and if hyperglycemic symptoms occur, they should consult their healthcare provider immediately. This medication can cause Neuroleptic Malignant Syndrome, which is characterized by severe muscle rigidity, high fever, and altered consciousness. If such symptoms occur, treatment should be discontinued immediately and medical attention should be sought. Prolonged use may lead to extrapyramidal symptoms such as tremors in the hands and feet or muscle rigidity; if such symptoms occur, consider dosage adjustment or discontinuation. Elderly patients with dementia may have an increased risk of death when using this medication, thus requiring special caution. There is a risk of severe neutropenia or agranulocytosis leading to a rapid decrease in blood cell count; therefore, blood tests should be conducted regularly, and symptoms of infection should be reported to healthcare personnel immediately. Patients with a risk of cerebrovascular disease may have an increased risk of stroke with this medication, thus careful administration is necessary, and thromboembolic risk factors should be assessed and preventative measures taken. Patients with cardiovascular disease or hypotension should be closely monitored as symptoms of dizziness or orthostatic hypotension may occur. Rarely, life-threatening Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious skin reactions may occur; discontinue immediately if symptoms such as rash or fever develop. This medication should not be administered to patients with allergies to certain components, in a comatose state, those on central nervous system depressants, patients receiving epinephrine, or diabetic patients. Patients with impaired liver function, the elderly, those with cardiovascular disease, individuals at risk of suicide, pregnant or nursing women, should be carefully administered this medication, with dosage adjustments and ongoing monitoring of their condition. Common side effects during usage may include drowsiness, dizziness, dry mouth, weight gain, changes in blood glucose and lipid levels, and extrapyramidal symptoms. Caution is advised when this medication is taken with other central nervous system depressants or alcohol, as the likelihood of sedation side effects may increase. Pregnant or nursing women should consult their physician before taking this medication, as it may affect the fetus or neonate. The safety of this medication in children and adolescents under 18 has not been established, and its use is not recommended. In case of overdose, severe drowsiness, hypotension, and increased heart rate may occur, and since there is no specific antidote, immediate medical treatment is necessary. Store this medication out of the reach of children and do not transfer to other containers.

• 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, and it is best kept at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

White to grayish-white, double-convex rectangular controlled-release film-coated tablets

Package unit

60 tablets (10 tablets/PTP x 6)