Quetiapine Extended-Release Tablets 400 mg (Quetiapine Fumarate)

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 the range of 400∼800 mg once daily according to each patient's response and tolerability. The dose may be increased by up to 300 mg per day at 1-day intervals. The safety of doses exceeding 800 mg per day has not been evaluated in clinical trials. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had stabilized after receiving this medicine for 16 weeks and were then 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. 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, increase the dose to 600 mg on Day 2, and from Day 3 onward, adjust the dose within the range of 400∼800 mg once daily according to the individual patient's clinical response and 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 the daily dose of quetiapine set at 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 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 the same dose. The dose may be adjusted within the range of 300∼800 mg once daily according to the clinical response and tolerability of each patient. It is important to use the minimum effective dose for maintenance therapy. 3. 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 doses of 150∼300 mg once daily. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg once 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; the same total daily dose can be administered once daily. 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 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 once daily. 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 required. ○ 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 once daily 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: 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 behavior in children, adolescents, and young adults; therefore, it should be administered with caution, especially in patients aged 18 to 24 years. Blood sugar levels may increase during the use of this medication, so patients with diabetes or those at risk for diabetes should monitor and manage their blood sugar levels frequently. Rarely, symptoms of severe neuroleptic malignant syndrome may occur, characterized by high fever, muscle rigidity, and altered mental status, necessitating immediate consultation with a doctor if these symptoms arise. With prolonged use, extrapyramidal symptoms or tardive dyskinesia may develop, so if abnormal movements or muscle rigidity occur, dose adjustments or discontinuation should be considered. It is advisable not to use this medication in elderly patients with dementia, as it may increase the risk of mortality. Patients with significantly low neutrophil counts should discontinue this medication and undergo blood tests as directed by a physician, as the drug can cause a rapid decrease in neutrophil levels. Patients at risk for cerebrovascular diseases may have an increased risk of stroke, thus require careful monitoring. There is a risk of venous thromboembolism (a condition where a clot obstructs veins), so patients with risk factors for thrombosis must take comprehensive preventative measures. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension or cardiac-related side effects upon taking this medication; therefore, close monitoring is advised. Severe skin reactions may occur, so if symptoms such as skin rash, fever, or swollen lymph nodes appear, immediate discontinuation and consultation with a doctor are warranted. This medication should not be administered to patients with hypersensitivity, those in a coma, on central nervous system depressants, using epinephrine, diabetic patients, or those with certain genetic lactose intolerance. Patients with impaired liver function should start with a lower dose and closely monitor their condition while gradually adjusting the dosage. Women who are pregnant or may become pregnant, as well as nursing mothers, should consult a doctor before taking this medication and carefully consider the potential effects on the fetus and newborn if necessary. Common side effects include drowsiness, dizziness, dry mouth, and weight gain; therefore, caution is advised for activities requiring alertness such as driving or operating machinery. Abrupt discontinuation of this medication may cause withdrawal symptoms, so it is important to gradually reduce the dose under medical supervision. When taken with other central nervous system medications or alcohol, the effects of this drug may be enhanced, requiring caution in such combinations. In case of an overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may occur; immediate treatment and monitoring by medical personnel are necessary due to the absence of a specific antidote.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, back pain, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophil count, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, hepatic failure, urinary retention, cutaneous vasculitis, drug reaction with eosinophilia and systemic symptoms, increased suicidal tendency, paralytic ileus, thromboembolism, fatigue, visual disturbances

Store this medication in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 15 to 30 degrees Celsius at room temperature.

Appearance

White to off-white, oval-shaped, bilayered, biconvex, extended-release film-coated tablet

Package unit

60 tablets (10 tablets/blister x 6)