Quetiapine Fumarate Extended-Release Tablets 150 mg

Adult dose

This drug is administered once daily in the evening. The tablet must be swallowed whole and must not be split, chewed, or crushed. Avoid taking this drug with food, or take it with a low-fat meal (approximately 300 calories). 1. Schizophrenia Adults: Initiate treatment with 300 mg of quetiapine, and adjust the dose within the range of 400∼800 mg once daily according to the individual 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. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had stabilized after receiving this drug for 16 weeks and were treated for 1 year or until relapse, this drug 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 drug 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 once daily according to the individual patient's clinical response and tolerability. Recommended dosing schedule Treatment day Day 1 Day 2 Day 3 Dose of this drug 300 mg 600 mg 400∼800 mg - Acute treatment of depressive episodes associated with bipolar disorder Adults: This drug is used 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. Recommended dosing schedule Treatment day Day 1 Day 2 Day 3 Day 4 Dose of this drug 50 mg 100 mg 200 mg 300 mg - Prevention of recurrence of bipolar disorder in patients who have responded to quetiapine treatment for manic, mixed, or depressive episodes For prevention of 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 once daily according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance treatment. 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 drug has been established at 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 drug for convenience of administration, with once-daily administration at the same total daily dose. Individual dose adjustment may be necessary. ○ Elderly patients: As with other antipsychotics, this drug should be administered with caution in elderly patients, particularly when administering the initial dose. The dose should be increased gradually, and the daily therapeutic dose may be lower than that in adult patients. The mean plasma clearance of quetiapine may be reduced by 30∼50% in elderly patients compared with adult patients. Elderly patients should start with a dose of 50 mg once daily. Increase the dose by 50 mg per day 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 drug, 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 that in adult patients; however, dose adjustment is generally not required. ○ Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, this drug should be administered with caution to patients with hepatic impairment, particularly when administering the initial dose. Patients with hepatic impairment should start with a dose of 50 mg once daily; the dose may be increased by 50 mg per day until an effective dose is reached, according to the individual patient's clinical response and tolerability.

Child dose

○ Children and adolescents: The safety and efficacy of this drug 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 children, adolescents, and young adults, so careful assessment by the physician and close observation of behavioral changes by patients and guardians are necessary when administering to this age group. There may be an increase in blood sugar during treatment, so diabetic patients or those with risk factors for diabetes should regularly monitor blood sugar levels and symptoms. This medication can, though rarely, cause serious symptoms of Neuroleptic Malignant Syndrome, which includes high fever, muscle rigidity, and changes in consciousness; patients should immediately inform healthcare providers if these symptoms occur. Long-term use may lead to movement disorders, such as extrapyramidal symptoms or tardive dyskinesia, so if symptoms appear, consideration should be given to dosage adjustment or discontinuation in consultation with a physician. In elderly patients with dementia, the use of this medication may increase the risk of death, so it should be avoided or used very cautiously in this population. There may be a severe decrease in white blood cells or agranulocytosis, so regular blood tests should be conducted to monitor white blood cell counts, and if symptoms of infection occur, immediate treatment should be sought. Special caution is warranted when administering this medication to patients at risk for cerebrovascular disease, as there may be an increased risk of stroke. Due to the risk of venous thromboembolism, risk factors for thrombosis should be monitored and preventive measures taken while using this medication. Patients with cardiovascular disease or hypotension should be closely monitored for orthostatic hypotension or other cardiovascular abnormalities when taking this medication. This medication can cause severe skin reactions; if symptoms like skin rash or fever occur, the medication should be stopped immediately and healthcare providers consulted. This medication should not be administered to patients with specific allergies, comatose states, those taking central nervous system depressants, patients receiving epinephrine, patients with diabetes or a history of diabetes, and those with lactose intolerance. Patients with impaired liver function should start at a lower dose and gradually increase while closely monitoring their condition. Pregnant or breastfeeding women should consult a physician before taking this medication as it can affect the fetus or newborn, and breastfeeding should be avoided if possible. This medication may cause various side effects such as drowsiness, dizziness, dry mouth, weight gain, changes in blood parameters, etc., and patients should immediately inform healthcare providers of any unusual symptoms. Treatment discontinuation should not be abrupt; tapering off slowly should be done to prevent acute withdrawal symptoms. This medication may have intensified side effects when taken with other central nervous system depressants or alcohol, so care should be taken when combined with these substances. Overdose requires immediate emergency treatment, as there is no specific antidote and intensive management by healthcare providers is necessary. Keep out of reach of children and do not store in other containers for safety.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, weight increase, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disturbances, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to somnambulism, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in various parts of the body, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, increase in blood sugar levels to hyperglycemia, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reaction accompanied by eosinophilia and systemic symptoms, skin vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly closed container to protect from air exposure and kept at room temperature between 15 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness.

Appearance

White to pale yellow, biconvex, rectangular extended-release film-coated tablets

Package unit

60 tablets (10 tablets/PTP packaging × 6)