Quetiapine Extended-Release Tablets 200 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). Adults with schizophrenia: 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 receiving this medication for 16 weeks 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 each patient's clinical response and tolerability. 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 medication 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. Day 1 50 mg Day 2 100 mg Day 3 200 mg Day 4 300 mg Prevention of recurrence in patients who responded to quetiapine treatment for manic, mixed, or depressive episodes: To prevent recurrence of manic or 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 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 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 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 receiving quetiapine fumarate immediate-release tablets may be switched to this medication for convenience of administration, allowing 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 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. 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: Following oral administration of this medication, the mean oral creatinine clearance in patients with severe renal impairment (creatinine clearance 10∼30 mL/min/1.73 m2) is reduced by 25% compared with that in adult patients; however, dose adjustment is generally not required. 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, and increase the dose 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 medicine have not been established in children and adolescents 18 years of age or younger.

This medication may increase the risk of suicidal thoughts or behaviors in younger populations with major depressive disorder or other psychiatric conditions, so careful assessment by a physician prior to use is necessary. Additionally, patients with diabetes or at risk of hyperglycemia should frequently monitor and manage their blood sugar levels, and consult promptly with a healthcare professional if hyperglycemic symptoms occur. This drug can cause a rare but serious side effect known as neuroleptic malignant syndrome; if symptoms such as high fever, muscle rigidity, or altered mental status occur, administration should be stopped immediately, and treatment should be sought. Long-term use may cause tardive dyskinesia, a movement disorder, and if symptoms appear, a consultation with a physician should be made to consider dosage adjustment or discontinuation. Special caution is required for elderly patients with dementia as this medication can increase the risk of mortality. This drug may cause severe agranulocytosis or neutropenia, thus regular monitoring of white blood cell counts and vigilance for infection symptoms are necessary. Patients at risk for cerebrovascular disease should use this medication cautiously due to increased risk of stroke, and potential for venous thromboembolism should also be assessed and managed in advance. Patients with cardiovascular diseases or hypotension should be aware of potential orthostatic hypotension and dizziness during initial dosing. This medication can cause serious skin adverse reactions, so if extensive rashes or fever occur, administration should be stopped immediately. Pregnant or nursing women should consult a doctor prior to use as this may affect the fetus or newborn. Safety and efficacy have not been established in children or adolescents, thus it is not recommended. Overdose may result in drowsiness, sedation, hypotension, etc., so the dosage should be strictly adhered to, and in case of overdose, immediate medical attention is required. This drug may affect the central nervous system, potentially causing drowsiness or dizziness, so it is advisable to avoid driving or operating hazardous machinery after taking it. Moreover, combining with other central nervous system depressants or alcohol may exacerbate side effects, so caution is advised. Abrupt discontinuation of this medication may result in withdrawal symptoms, so any reduction should be done gradually following a physician's guidance.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglycerides, 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, sleepwalking, dry mouth, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, 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, hyperactivity, fever, hypothermia, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, elevated blood glucose levels, increased serum prolactin, decreased total T4, decreased free T4, decreased total T3, increased TSH, increased AST, 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 medicine should be stored in a tightly closed container to prevent air or moisture from entering, and it is best kept at room temperature between 15°C to 30°C to maintain its efficacy over time.

Appearance

White to off-white, biconvex, rectangular, extended-release film-coated tablets

Package unit

60 tablets (10 tablets/blister x 6)