Quetiapine Extended Release 300 mg (Quetiapine Fumarate)

Adult dose

Administer this medicine once daily in the evening. Swallow this medicine 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, and adjust the dose within 400∼800 mg per day 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 per day has not been evaluated in clinical trials. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had stabilized after 16 weeks of treatment with this medicine and were 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 to 600 mg on Day 2, and from Day 3 onward, adjust the dose within 400∼800 mg per day according to the individual patient's clinical response and tolerability. Recommended dosing schedule Treatment day 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: As monotherapy, the daily dose of this medicine, expressed as 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 medicine 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 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 300∼800 mg per day according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. 3. Adjunctive treatment of major depressive disorder ○ Adults: Initiate treatment with 50 mg on Day 1 and increase the dose to 150 mg on Day 3. The efficacy of this medicine has been established at 150∼300 mg per day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg per day 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; it can be administered 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 therapeutic daily 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. Initiate treatment in elderly patients at 50 mg per day. 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: After 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 necessary. ○ 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. Initiate treatment in patients with hepatic impairment at 50 mg per day 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

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

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so if prescribing to patients in these age groups, the physician should carefully evaluate the risks and benefits. Blood glucose may increase while taking this medication, and patients with diabetes or risk factors for diabetes should regularly monitor their blood glucose levels. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, and patients should notify healthcare professionals immediately if they experience high fever, muscle rigidity, or changes in mental state. Prolonged use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, and any abnormal symptoms should be discussed with healthcare professionals. Elderly patients with dementia may have an increased risk of mortality when using this medication, so its use is not recommended. This medication can cause serious agranulocytosis or leukopenia, so blood leukocyte counts should be regularly monitored, and treatment should be sought immediately if any signs of infection occur. Patients with a history of cardiovascular or cerebrovascular disease may have an increased risk of hypotension or stroke when using this medication, so caution is necessary. Due to a risk of thrombosis, patients with thrombotic risk factors require careful monitoring and preventive measures before and during use. Patients with liver dysfunction may experience elevated blood concentrations of this medication, so starting with a lower dose and closely monitoring their condition is necessary. This medication may commonly cause side effects such as drowsiness, dizziness, or dry mouth, so caution is necessary when driving or operating machinery. Concomitant use with antidepressants or other central nervous system depressants may worsen side effects, and consultation with healthcare professionals is advisable. Pregnant or breastfeeding women should consult a physician before using this medication, as it may affect the fetus or newborn; it is preferable to avoid use while breastfeeding. This medication may induce withdrawal symptoms if suddenly discontinued, so when stopping treatment, the dosage should be gradually reduced. In case of overdose, severe drowsiness, hypotension, and cardiac issues may occur, requiring immediate medical attention. This medication has not been established for safety and efficacy in children and adolescents, and its use is not recommended.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglycerides, 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, indigestion, vomiting, difficulty swallowing, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, elevated blood glucose levels, increased serum prolactin, 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, thrombosis, fatigue, visual disturbances

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is advisable to store it at room temperature between 15 and 30 degrees Celsius. Proper storage can maintain the medication's effectiveness.

Appearance

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

Package unit

60 tablets (10 tablets/PTP × 6)