Seroquel Extended-Release Tablets 400 mg (Quetiapine Fumarate)

Adult dose

This medicine is administered once daily in the evening. Swallow this medicine 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). Schizophrenia Adults: Initiate treatment with 300 mg of quetiapine, and adjust the dose within a 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. In a therapeutic confirmatory clinical trial in patients with schizophrenia who had stabilized after 16 weeks of treatment with this medicine and were 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. 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, increase to 600 mg on Day 2, and from Day 3 onward, adjust the dose within a range of 400～800 mg per day according to the individual patient's clinical response and tolerability. Recommended dosing schedule Day of treatment Day 1: 300 mg Day 2: 600 mg Day 3: 400～800 mg Acute treatment of depressive episodes associated with bipolar disorder Adults: As monotherapy, the daily dose of this medicine, expressed as quetiapine, should be 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: 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 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 a 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 medicine 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 quetiapine fumarate immediate-release tablets may switch to this medicine for convenience of administration, and may take 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 to elderly patients, particularly when initiating treatment. The dose should be increased gradually, and the therapeutic daily 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 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: Following oral administration of this medicine, the 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 necessary. Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, this medicine 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 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

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

This medication is an antipsychotic used for the treatment of various psychiatric disorders. When using this medication, there may be an increased risk of suicidal thoughts or behaviors, especially in young patients aged 18 to 24, who should be closely monitored. Patients with diabetes or those at risk of diabetes should frequently check their blood sugar levels, and if hyperglycemia symptoms occur, they must consult medical professionals immediately. There is a rare but serious side effect known as neuroleptic malignant syndrome, which may arise. If high fever, muscle rigidity, or changes in consciousness occur, stop taking the medication immediately and seek treatment. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia; therefore, consideration should be given to dose adjustment or discontinuation if these symptoms arise. This medication is not recommended for elderly patients with dementia as its use may increase the risk of death. Blood adverse reactions such as neutropenia or agranulocytosis may occur, so especially if infection symptoms occur, the hospital should be notified immediately. Patients at risk for cerebrovascular disease may have an increased risk of stroke when using this medication; therefore, extra caution is needed. There is a risk of venous thromboembolism, so patients with thrombotic risk factors should be carefully observed before and during the use of this medication. Patients with cardiovascular disease or those at risk for hypotension may experience orthostatic hypotension or dizziness during initial dosing and should be monitored while gradually increasing the dose. Serious skin adverse reactions may occur; if symptoms such as rash, skin peeling, fever occur, the medication should be stopped immediately and medical advice should be sought. Common side effects while taking this medication include drowsiness, dizziness, dry mouth, weight gain, and lipid abnormalities, so these symptoms should be reported to medical personnel. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as withdrawal symptoms or movement disorders may appear in newborns, especially in the late stages of pregnancy. Safety and effectiveness in patients under 18 years of age have not been established; hence it is not recommended. Taking this medication with alcohol or other central nervous system depressants may increase drowsiness or decreased concentration, so caution should be exercised when driving or operating machinery. Abrupt discontinuation may lead to withdrawal symptoms; therefore, it is safer to taper off the medication gradually. This medication can interact with various drugs, so if taking other medications, it is essential to inform the healthcare provider. In case of overdose, severe drowsiness, hypotension, and tachycardia may occur, requiring immediate emergency treatment. When storing, keep this medication out of the reach of children and avoid transferring it to other containers.

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, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel occlusion, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, hypersensitivity reaction, anaphylactic reaction, 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, hyperglycemia, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, cutaneous vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), intestinal paralysis, myalgia, weakness, elevated CK, increased serum and urinary myoglobin, acute kidney injury, pulmonary thrombosis, venous thrombosis, fatigue, visual disturbances

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain storage temperatures between 15 and 30 degrees Celsius.

Appearance

White, capsule-shaped, biconvex film-coated tablets

Package unit

60 tablets (10 tablets/PTPX6)