Quetiapine Fumarate Extended-Release Tablet 300 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). Adults with schizophrenia: 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. Adults with acute manic or mixed episodes associated with bipolar I disorder: 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 1 300 mg, Day 2 600 mg, Day 3 400∼800 mg Adults with acute depressive episodes associated with bipolar disorder: 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 1 50 mg, Day 2 100 mg, Day 3 200 mg, Day 4 300 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. Adults receiving adjunctive treatment for major depressive disorder: 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

Children and adolescents under 18 years of age: The safety and efficacy of this medicine have not been established.

This medication is primarily used as an atypical antipsychotic for the treatment of psychiatric disorders. When taking this medication, there may be an increased risk of suicidal thoughts and behaviors, especially in young adults and adolescents between the ages of 18 and 24, so it should be administered under the careful judgment of a physician. It may raise blood glucose levels, so individuals with diabetes or a family history of diabetes should consult a doctor before use and monitor blood sugar regularly. This medication can occasionally cause a serious side effect known as neuroleptic malignant syndrome, and if symptoms such as high fever, muscle rigidity, or changes in mental status occur, medical personnel should be notified immediately. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so if abnormal movements occur, patients should consult a doctor. Elderly patients with dementia may be at an increased risk of death when using this medication, so special caution is needed. Additionally, this medication may cause blood abnormalities such as severe neutropenia or agranulocytosis, requiring regular monitoring of white blood cell counts. Patients with cardiovascular disease, hypotension, or cerebrovascular disease may experience dizziness or blood pressure changes while taking this medication, so care should be taken. This medication may trigger severe allergic skin reactions, and if symptoms such as extensive skin rashes, fever, or lymphadenopathy occur, use should be discontinued and the healthcare provider notified immediately. This medication should not be taken in conjunction with certain drugs like barbiturate central nervous system depressants or epinephrine, and should not be administered to lactose intolerant patients. Patients with impaired liver function should start at a low dose and monitor their condition closely. Pregnant or breastfeeding women should consult with a physician before taking this medication, as it may affect the fetus or newborn. Common side effects such as drowsiness, dizziness, dry mouth, and weight gain may occur, so care should be taken when driving or operating machinery. Suddenly stopping the medication may lead to withdrawal symptoms, so dosage should be gradually reduced according to the doctor's instructions. Overdose may result in severe hypotension, sedation, tachycardia, and immediate medical treatment is required, as there is no specific antidote for overdose. This medication is not recommended for use in children and adolescents, as safety and efficacy have not been established. Regular blood tests and clinical monitoring are necessary during treatment, and any abnormal symptoms should be reported to medical personnel immediately.

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, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity, anaphylaxis, blurred vision, pain in the extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, elevated blood glucose 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, withdrawal symptoms, convulsions, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 15 to 30 degrees Celsius. Proper storage will help preserve the effectiveness and safety of the medication.

Appearance

White to greyish-white, double-convex oblong extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP packaging × 6)