Quetiapine Fumarate Extended-Release Tablets 400 mg

Adult dose

Administer this medicine once daily in the evening. Swallow the tablet whole; do not split, chew, or crush it. Avoid taking this medicine with food, or take it with a low-fat meal (approximately 300 calories). 1. Schizophrenia Adults: Initiate treatment with 300 mg of quetiapine. Adjust the dose within 400∼800 mg daily 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 daily has not been evaluated in clinical trials. In a confirmatory therapeutic clinical trial in patients with schizophrenia who were stabilized after receiving this medicine for 16 weeks and then treated for 1 year or until relapse, this medicine 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. 2. Bipolar disorder - Acute treatment of manic or mixed episodes associated with bipolar I disorder Adults: This medicine may be used as monotherapy or as adjunctive therapy to lithium or valproate. Initiate treatment with 300 mg of quetiapine on day 1 and increase to 600 mg on day 2. From day 3 onward, adjust the dose within 400∼800 mg daily according to the individual patient's clinical response and drug tolerability. Recommended dosing schedule Day of treatment Day 1 Day 2 Day 3 Dose of this medicine 300 mg 600 mg 400∼800 mg - Acute treatment of depressive episodes associated with bipolar disorder Adults: This medicine is used as monotherapy, with a daily dose of quetiapine of 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. Recommended dosing schedule Day of treatment Day 1 Day 2 Day 3 Day 4 Dose of this medicine 50 mg 100 mg 200 mg 300 mg - Prevention of recurrence of bipolar disorder in patients who have responded to quetiapine for manic, mixed, or depressive episodes To prevent recurrence of mania, mixed episodes, or depression 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 300∼800 mg daily according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. 3. Adjunctive treatment of major depressive disorder Adults: Initiate this medicine at 50 mg on day 1 and increase to 150 mg on day 3. Efficacy of this medicine has been established at 150∼300 mg daily. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg daily have not been studied. ○ Switching from immediate-release tablets: Patients taking immediate-release quetiapine fumarate tablets may switch to this medicine for convenience of administration, taking it once daily at the same total daily dose. Individual dose adjustment may be necessary. ○ Elderly patients: As with other antipsychotics, this medicine should be administered with caution in 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. Mean plasma clearance of quetiapine may be reduced by 30∼50% in elderly patients compared with adult patients. Start elderly patients at 50 mg daily. Increase the dose by 50 mg daily until an effective dose is reached, according to the individual patient's clinical response and tolerability. ○ Patients with renal impairment: After oral administration of this medicine, mean oral clearance 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 required. ○ Patients with hepatic impairment: Quetiapine is primarily metabolized in the liver; therefore, use this medicine with caution in patients with hepatic impairment, particularly when initiating treatment. Start patients with hepatic impairment at 50 mg daily and increase the dose by 50 mg daily until an effective dose is reached, according to the individual patient's clinical response and tolerability.

Child dose

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

This medication requires caution in patients with suicidal tendencies, especially young adults aged 18 to 24, as well as in children and adolescents. The use of antidepressants in combination may increase the risk of suicidal impulses or behaviors, so physicians must carefully evaluate the need for treatment and the associated risks. During treatment with this medication, blood sugar levels may increase, and patients with diabetes or risk factors for diabetes should regularly monitor and manage their blood sugar levels. There is a rare risk of developing a serious side effect known as Neuroleptic Malignant Syndrome, characterized by high fever, muscle rigidity, and changes in mental state; immediate medical attention is necessary if these symptoms occur. Long-term use may lead to extrapyramidal symptoms and tardive dyskinesia, so if abnormal symptoms occur, consideration should be given to adjusting or discontinuing the medication. It is recommended that this medication not be used in elderly patients with dementia, as there may be an increased risk of mortality associated with its use. Blood abnormalities such as severe neutropenia or agranulocytosis may occur, thus regular monitoring of white blood cell counts is necessary, and immediate treatment should be sought if infection symptoms arise. In patients at risk for cerebrovascular disease, careful administration is necessary as there may be an increased risk of stroke. Due to the risk of venous thrombosis, patients with thrombotic risk factors should take preventive measures and monitor for abnormal symptoms. Patients with cardiovascular diseases or risks of hypotension should be carefully monitored for orthostatic hypotension during the use of this medication. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS may occur, so if symptoms such as skin rash or fever arise, it is crucial to stop the medication immediately and seek medical attention. This medication should not be administered to patients with hypersensitivity to certain components, patients in a coma, patients taking central nervous system depressants such as barbiturates, patients undergoing epinephrine administration, patients with diabetes, and patients who are lactose intolerant. Patients with impaired liver function, history of cardiovascular disease or cerebrovascular disease, patients with seizure disorders, the elderly, patients with suicidal attempts or thoughts, patients with risk factors for diabetes, pregnant women, and nursing mothers should use this medication with caution. This medication may cause various side effects such as drowsiness, dizziness, dry mouth, weight gain, dyslipidemia, extrapyramidal symptoms, speech difficulties, seizures, restless legs syndrome, syncope, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, blurred vision, pain, muscle pain, etc. During treatment, it is advisable to avoid activities that require attention, such as driving or operating machinery, especially when taken with other central nervous system depressants or alcohol. Pregnant women should consider the potential effects on the fetus and are advised to take this medication only when necessary, while breastfeeding women are recommended to avoid breastfeeding while taking this medication. Abrupt discontinuation of this medication may cause withdrawal symptoms, so dosages should be gradually reduced according to a physician's directions. In case of overdose, immediate medical attention should be sought for appropriate treatment, as there is no specific antidote. This medication is not recommended for children and adolescents due to lack of established safety and efficacy.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, 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 associated with eosinophilia and systemic symptoms, skin vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thrombosis, fatigue, visual disturbances

Store this medication in a tightly closed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 15°C and 30°C.

Appearance

White to off-white, oval, double-convex, extended-release film-coated tablets

Package unit

60 tablets (10 tablets/PTP packaging × 6)