Seroquel Extended Release 200 mg (Quetiapine Fumarate)

Adult dose

This medicine should be administered 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). Adults: Initiate treatment with quetiapine 300 mg, and 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. Adults: This medicine may be used as monotherapy or as adjunctive therapy to lithium or valproate. Initiate treatment with quetiapine 300 mg 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 per day according to each patient's clinical outcome and drug tolerability. Day 1 300 mg Day 2 600 mg Day 3 400～800 mg Adults: As monotherapy, the daily dose of quetiapine should be 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. Day 1 50 mg Day 2 100 mg Day 3 200 mg Day 4 300 mg For the prevention of recurrence of manic episodes, mixed episodes, and depression associated with bipolar disorder, patients who responded to quetiapine during acute treatment of bipolar disorder should be maintained on the same dose. 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 minimum effective dose for maintenance therapy. 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 doses of 150～300 mg per day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg per day have not been studied. Patients receiving immediate-release quetiapine fumarate tablets may be switched to this medicine for convenience of administration, with once-daily administration at the same total daily dose. Individual dose adjustment may be necessary. For elderly patients, initiate treatment 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. Following oral administration of this medicine to patients with severe renal impairment (creatinine clearance 10～30 mL/min/1.73 m2), mean oral creatinine clearance is reduced by 25% compared with that in adult patients; however, dose adjustment is generally not necessary. For patients with hepatic impairment, initiate treatment at a dose of 50 mg per day. The dose may be increased 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 or younger: The safety and efficacy of this medicine have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults; thus, physicians should carefully assess the necessity and risks when prescribing to this age group. Patients taking this medication are at risk for hyperglycemia or worsening of diabetes; therefore, blood sugar levels should be monitored regularly, and immediate consultation with a doctor is required if symptoms of diabetes appear. This medication may rarely cause a serious side effect known as Neuroleptic Malignant Syndrome, which includes symptoms such as high fever, muscle rigidity, and altered consciousness; treatment should be sought immediately if these unusual symptoms occur. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so any abnormal movements should be reported to a doctor. Elderly patients with dementia may have an increased risk of death with this medication, so caution is needed. Severe neutropenia or agranulocytosis, characterized by a significant drop in white blood cell count, can occur; if symptoms of infection or fever appear, a hospital visit is necessary. In patients with a history of cerebrovascular disease, this medication may increase the risk of stroke; hence, special caution should be exercised. There is a risk of venous thromboembolism, so if symptoms such as leg pain, swelling, or shortness of breath occur, medical personnel should be notified immediately. Patients with cardiovascular disease, hypotension, liver impairment, or seizure history should have their dosage adjusted and their condition closely monitored. This medication may cause severe skin reactions; if symptoms such as skin rash, fever, or swollen lymph nodes develop, immediate discontinuation and consultation with a physician is advised. Pregnant or nursing women should consult with a doctor when considering this medication, as it may affect the fetus or newborn, and it is recommended to avoid use while breastfeeding. This medication is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established. In case of overdose, symptoms such as drowsiness, hypotension, and cardiac arrhythmias may occur; immediate emergency treatment is required as there is no specific antidote. Caution is advised when driving or operating machinery during treatment, and combination with alcohol or other central nervous system depressants may intensify side effects. During treatment, weight gain, changes in blood lipids and glucose levels may occur; regular monitoring is necessary, and any unusual symptoms should be reported to a doctor. Sudden discontinuation of this medication may induce withdrawal symptoms; therefore, cessation should be done gradually under a doctor's guidance.

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, dysphonia, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in various locations, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, increase in blood glucose levels to hyperglycemic levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly sealed container to protect it from air and moisture, at room temperature between 15 degrees and 30 degrees Celsius. This storage method helps maintain the drug's effectiveness.

Appearance

Yellow capsule-shaped, bilaterally convex film-coated tablets

Package unit

60 tablets (10 tablets/PTPX6)