Seroquel Extended Release 300 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. 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 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 1 50 mg, Day 2 100 mg, Day 3 200 mg, Day 4 300 mg Prevention of recurrence of bipolar disorder: 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: The dose should be increased gradually, and the therapeutic daily dose may be lower than that for 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: Dose adjustment is generally not necessary. Patients with hepatic impairment: 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

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

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric diseases; therefore, when administering to this age group, the physician must carefully assess the need for and risks of treatment. Patients taking this medication may have an increased risk of hyperglycemia or diabetes, necessitating regular blood glucose monitoring, especially if there is a history of diabetes or risk factors. This medication may rarely cause a serious side effect known as Neuroleptic Malignant Syndrome, which includes severe fever, muscle rigidity, and changes in mental state. If these symptoms appear, treatment must be stopped immediately and applicable treatment should be sought. Long-term use can result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia. If symptoms appear, dose adjustment or discontinuation of therapy should be considered. This medication is not approved for use in elderly patients with dementia and should be avoided due to an increased risk of death. Severe neutropenia or agranulocytosis may occur; if there is a decrease in white blood cells, treatment should be stopped immediately, and symptoms of infection should be carefully monitored. Patients with a risk of cerebrovascular disease may have an increased risk of vascular issues such as stroke, requiring special caution. There is a risk of venous thromboembolism; patients with risk factors for thrombosis should be monitored closely before and after administration. Patients with cardiovascular disease or hypotension require careful monitoring, as this medication may cause orthostatic hypotension. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may occur; immediate reporting to a physician is required if symptoms like rash or fever arise. This medication should not be administered to certain patients, such as those who have hypersensitivity to its components, are in a comatose state, are taking strong CNS depressants, are receiving epinephrine, or have a history of diabetes. Patients with compromised liver function or cardiovascular and cerebrovascular diseases, elderly patients, patients at risk of suicide, and pregnant or nursing women should be administered with caution, requiring dose adjustments and monitoring of states. Common side effects like drowsiness, dizziness, dry mouth, weight gain, abnormal blood lipid levels, extrapyramidal symptoms, etc., should be watched for. Sudden discontinuation may cause withdrawal symptoms, so tapering off the dose gradually is crucial. As this medication affects the central nervous system, it may cause drowsiness or decreased attention; therefore, caution is advised when driving or operating machinery after taking it. There may be drug interactions, especially with CNS depressants, strong CYP3A4 inhibitors, and serotonergic drugs, requiring careful management under a physician's guidance. If pregnant women take this medication, withdrawal symptoms may occur in the newborn, thus administration during pregnancy must consider the safety of the fetus and newborn, and avoidance during breastfeeding is advised. The safety and efficacy of this medication have not been established for children and adolescents, thus it is not recommended for use. For the elderly, drug metabolism may slow down, requiring initiation at a low dose and gradual increase while closely monitoring for side effects.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, weight gain, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dizziness, headache, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to sleepwalking, dry mouth, constipation, dyspepsia, vomiting, difficulty swallowing, intestinal obstruction, shortness of breath, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reaction, anaphylaxis, blurred vision, pain in the extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, withdrawal symptoms, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, neuroleptic malignant syndrome, hypothermia, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, increase in blood sugar levels to hyperglycemic levels, increased serum prolactin, decreased total T4, decreased non-bound T4, decreased total T3, increased TSH, increased AST, decreased platelets, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendency, paralytic ileus, rhabdomyolysis, thrombosis and embolism, fatigue, visual disturbances

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 15 to 30 degrees Celsius.

Appearance

Pale yellow, capsule-shaped, double-convex film-coated tablet

Package unit

60 tablets (10 tablets/PTPX6)