Quetiapine Extended-Release Tablets 150 mg (Quetiapine Fumarate)

Adult dose

This medicine is 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). Schizophrenia, adults: Start treatment with 300 mg of quetiapine, and adjust the dose within the range of 400∼800 mg 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. 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. Start treatment with 300 mg of quetiapine on Day 1 and increase to 600 mg on Day 2. From Day 3 onward, the dose may be adjusted within the range of 400∼800 mg daily according to the individual patient's clinical response and tolerability. Acute treatment of depressive episodes associated with bipolar disorder, adults: This medicine is used as monotherapy. The daily dose 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. Prevention of recurrence of bipolar disorder in patients who have 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 daily according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. Adjunctive treatment of major depressive disorder, adults: Start 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 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, and may take 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 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 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, this medicine should be administered with caution to patients with hepatic impairment, particularly when initiating treatment. Patients with hepatic impairment should start with a dose of 50 mg daily. The dose may be increased 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 medicine have not been established in children and adolescents younger than 18 years.

This medication is primarily used for the treatment of psychiatric disorders and may increase suicidal tendencies, thus should be used with caution, especially in young patients aged 18 to 24 years. This medication may raise blood sugar levels, so patients with diabetes or those at risk for diabetes should regularly monitor and manage their blood sugar levels. Rarely, there may be a serious side effect known as Neuroleptic Malignant Syndrome, so if high fever, muscle rigidity, or changes in mental status occur, immediate consultation with a physician is necessary. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, thus should consider dose adjustment or discontinuation if such adverse symptoms occur. In elderly patients with dementia, the risk of death may increase, so it is preferable to avoid use. Blood dyscrasias such as agranulocytosis or neutropenia may occur, so regular monitoring of white blood cell counts is necessary. In patients with a risk of cerebrovascular disease, the risk of stroke may be heightened, hence caution should be exercised. There is a risk of venous thromboembolism, so patients with thrombosis risk factors should be evaluated for risk prior to use and take preventive measures. Patients with cardiovascular diseases, hypotension, or liver impairment should be cautious as there may be changes in blood pressure or drug concentration upon taking this medication. Severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) may occur, so if symptoms such as skin rashes or fever arise, the medication should be stopped immediately and consulted with a healthcare professional. This medication should not be administered in patients with certain genetic disorders and should not be used with central nervous system depressants or epinephrine. In patients with compromised liver function or the elderly, starting with a low dose is essential, and the conditions should be closely monitored for gradual dose adjustments. Pregnant or nursing women should use this medication cautiously after consulting with a physician, as it may affect the fetus or newborn. Stopping this medication suddenly may result in withdrawal symptoms, so tapering the dose gradually is necessary. Common side effects include drowsiness, dizziness, dry mouth, weight gain, and if these symptoms are severe, one should consult with a healthcare professional. This medication affects the central nervous system, so caution is needed when driving or operating machinery. There may be interactions with other medications, so if taking other medications, it is critical to inform healthcare staff. In cases of overdose, severe drowsiness, hypotension, and tachycardia may occur, and immediate medical attention is required. This medication is not recommended for children and adolescents due to insufficient safety and efficacy established.

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, dizziness, headache, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity, anaphylactic reaction, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, increased blood sugar, increased serum prolactin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, decreased platelet count, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reaction with eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 15 and 30 degrees Celsius at room temperature.

Appearance

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

Package unit

60 tablets (10 tablets/blister x 6)