Quetiapine Fumarate Extended-Release Tablets 50 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. 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

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

This medication is primarily used for the treatment of psychiatric disorders, especially prescribed for depression, schizophrenia, and bipolar disorder. Taking this medication may increase the risk of suicidal thoughts or actions; therefore, especially children, adolescents, and young adult patients require careful judgment and continuous observation by a physician. Patients with diabetes or those at risk for diabetes should regularly check their blood sugar levels, and if any symptoms of hyperglycemia appear, they must consult a medical professional immediately. A serious side effect known as Neuroleptic Malignant Syndrome may rarely occur; thus, if symptoms such as high fever, muscle rigidity, or changes in consciousness appear, they should notify the physician immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if there are unusual movements or discomfort, they should consult a medical professional. Elderly patients with dementia may have an increased risk of death, and the use of this medication is not recommended. Blood abnormalities such as agranulocytosis and neutropenia may occur, so patients presenting with symptoms of infection or fever should promptly visit the hospital. Patients at risk for cerebrovascular disease should exercise caution while taking this medication; there is also a risk of thrombosis, so if leg pain, swelling, or sudden shortness of breath occurs, they should notify their doctor immediately. Patients with cardiovascular diseases or hypotension may experience dizziness or fainting risks while taking this medication, so caution is required when standing up slowly. Severe skin reactions may occur; therefore, if symptoms such as skin rash, fever, or lymph node swelling develop, they must stop taking the medication immediately and consult a physician. This medication is not to be given to patients with specific allergies, patients in a comatose state, those receiving certain central nervous system depressants, those receiving epinephrine, diabetic patients, or lactose intolerant patients. Patients with impaired liver function, cardiovascular disease, history of seizures, the elderly, pregnant women, and nursing mothers require more careful observation and dosage adjustments. Abrupt discontinuation of this medication may lead to withdrawal symptoms; hence, the dosage should be gradually reduced under the guidance of a physician. Common side effects during use include drowsiness, dizziness, dry mouth, weight gain, blood sugar and lipid abnormalities, extrapyramidal symptoms, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, fainting, nightmares, sleepwalking, constipation, indigestion, vomiting, difficulty swallowing, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, and blurred vision.

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, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to 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 the back, myalgia, rhabdomyolysis, prolonged erection, galactorrhea, increased appetite, withdrawal symptoms, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, neuroleptic malignant syndrome, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes, increased γ-GT, decreased neutrophil count, increased eosinophil count, elevated blood sugar levels, increased serum prolactin, decreased total T4, decreased free 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, thromboembolism, fatigue, visual disturbances

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 15 to 30 degrees Celsius. This will help preserve the efficacy of the medication for a long time.

Appearance

White to grayish-white, double convex, round extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP packaging × 6)