Quetiapine Extended-Release Tablets 50 mg (Quetiapine Fumarate)

Adult dose

This medication is administered once daily in the evening. It must be swallowed whole and must not be split, chewed, or crushed. Avoid taking this medication with food, or take it with a low-fat meal (approximately 300 calories). Schizophrenia — Adults: Initiate treatment with 300 mg of quetiapine, and adjust the dose within the range of 400∼800 mg/day according to each patient's response and tolerability. The dose may be increased by up to 300 mg/day at 1-day intervals. The safety of doses exceeding 800 mg/day has not been evaluated in clinical trials. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had stabilized after 16 weeks of treatment with this medication and were treated for 1 year or until relapse, this medication was effective in prolonging the time to relapse in patients with schizophrenia. The physician should periodically reassess each patient to determine the need for continued treatment. 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 with 300 mg of quetiapine on Day 1, increase to 600 mg on Day 2, and, from Day 3 onward, adjust the dose within the range of 400∼800 mg/day according to the individual patient's clinical response and drug 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 responded to quetiapine treatment for manic, mixed, or depressive episodes — 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. The dose may be adjusted within the range of 300∼800 mg/day according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance treatment. 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/day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg/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, with once-daily administration at the same total daily dose. Individual dose adjustment may be necessary. Elderly patients: As with other antipsychotics, this medication should be administered with caution to elderly patients, particularly when initiating treatment. The dose should be increased gradually, and the daily therapeutic dose may be lower than that for 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 a dose of 50 mg/day. Increase the dose by 50 mg/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, the mean oral clearance of quetiapine in patients with severe renal impairment (creatinine clearance 10∼30 mL/min/1.73 m2) is reduced by 25% compared with adult patients; however, dose adjustment is generally not necessary. Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, this medication should be administered with caution to patients with hepatic impairment, particularly when initiating treatment. Initiate treatment in patients with hepatic impairment at a dose of 50 mg/day. The dose may be increased by 50 mg/day until an effective dose is reached, according to each patient's clinical response and tolerability.

Child dose

The safety and efficacy of this drug have not been established in children and adolescents 18 years of age or younger.

This drug may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults; therefore, caution should be exercised when prescribing to patients in these age groups, and the physician should carefully evaluate the risks and benefits. Patients taking this medication may develop diabetes or experience hyperglycemia, so regular blood glucose monitoring is essential, and symptoms of hyperglycemia such as thirst, frequent urination, and hunger should be closely observed. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome. If symptoms such as high fever, muscle rigidity, or changes in mental status occur, the patient should immediately inform healthcare personnel. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia; therefore, if abnormal movements or muscle spasms occur, consultation with a physician is recommended. The use of this medication in elderly patients with dementia is not recommended due to an increased risk of death. Blood abnormalities such as neutropenia can occur, and if symptoms of fever or infection arise, the patient must immediately notify healthcare personnel, and regular blood tests are needed. Patients at risk of cerebrovascular disease may experience an increased risk of stroke while taking this medication, necessitating special caution. This drug can increase the risk of thrombosis; therefore, symptoms such as leg pain, swelling, or shortness of breath should prompt immediate medical attention. Patients with cardiovascular disease or hypotension should be aware of dizziness or orthostatic hypotension symptoms, and dosage adjustments may be required if symptoms are severe. Severe skin reactions (such as Stevens-Johnson syndrome) may occur; thus, if skin rash, fever, or lymph node swelling occurs, the patient should discontinue the medication immediately and consult healthcare personnel. Women who are pregnant or breastfeeding should consult a physician before use, as it may affect the fetus or newborn, and it is advisable to avoid this medication while breastfeeding. Common side effects include drowsiness, dizziness, and dry mouth, so caution is necessary when driving or operating machinery. Co-administration with other central nervous system depressants or alcohol can exacerbate side effects; therefore, caution is warranted. Abrupt discontinuation of this medication may lead to withdrawal symptoms, so a gradual dose reduction is safer. In the case of overdose, severe drowsiness, hypotension, and tachycardia may occur, requiring immediate medical attention, and there is no specific antidote. This medication is metabolized in the liver; therefore, patients with hepatic impairment should start at a low dose and be closely monitored. During treatment, weight gain, changes in blood lipid and glucose levels may occur, necessitating regular health check-ups and lifestyle management. This medication should not be administered to patients with specific genetic metabolic disorders, nor should it be used in patients with hypersensitivity or in a comatose state. If any abnormal symptoms or suspected side effects occur during treatment, the patient should immediately consult a physician or pharmacist.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, fainting, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disturbance, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions with eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, to maintain the drug's effectiveness, it is important to store it at room temperature between 15 degrees and 30 degrees Celsius.

Appearance

White to pale yellow, double convex-shaped, round extended-release film-coated tablets

Package unit

60 tablets (10 tablets/blister x 6)