Quetiapine Extended-Release Tablets 200 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 behavior, so it should be used with great caution, especially in young patients aged 18 to 24. During the use of this medication, blood sugar levels may increase, so patients with diabetes or those at risk of hyperglycemia should regularly monitor their blood sugar levels. A serious side effect known as neuroleptic malignant syndrome may occur rarely, so if symptoms like high fever, muscle stiffness, or changes in mental state appear, immediate consultation with medical staff is necessary. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, which are movement disorders, so consulting a doctor is advised if these symptoms occur. It is advisable not to use this medication in elderly patients with dementia, as the risk of death may increase. Severe blood abnormalities like agranulocytosis or neutropenia may occur, so treatment should be discontinued if white blood cell counts are low. There may be an increased risk of cerebrovascular disease, so patients with risk factors for stroke should use this medication carefully. Due to the risk of venous thromboembolism, patients with thrombotic risk factors should verify this and take preventive measures. Patients with cardiovascular disease or hypotension should be cautious as orthostatic hypotension can occur upon initial dosing. Severe skin reactions may occur, so if extensive skin rash, fever, or lymphadenopathy appears, discontinue medication and inform medical staff immediately. This medication should not be given to patients with specific genetic lactose intolerance, and caution is necessary when used concurrently with central nervous system depressants or in a comatose state. Patients with decreased liver function should start at a low dose and gradually increase while closely monitoring their condition. Women who are pregnant or breastfeeding should consult medical staff before taking this medication, as it may affect the fetus or newborn. Common side effects include drowsiness, dizziness, dry mouth, weight gain, so caution is needed when driving or operating machinery. Abrupt discontinuation of this medication may lead to withdrawal symptoms, so the dosage should be gradually reduced. Interactions with other medications can occur, so patients should inform medical staff about any other medications they are taking, especially when used with strong liver enzyme inhibitors or central nervous system depressants. In cases of overdose, severe drowsiness, hypotension, or tachycardia may occur, and since there is no specific antidote, immediate emergency treatment is required. Children and adolescents should not be used as the safety and efficacy of this medication have not been established in this demographic. Elderly patients may have different bodily responses, so starting at a low dose and gradually increasing it while carefully monitoring is necessary. This medication should be stored out of reach of children, and transferring to another container should be avoided.

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, speech disorder, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, difficulty swallowing, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reaction, anaphylaxis, blurred vision, pain in various regions, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophil count, increased blood sugar levels towards hyperglycemia, increased serum prolactin, thrombocytopenia, elevated serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, cutaneous vasculitis, drug reactions accompanied by eosinophilia and systemic symptoms, 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 and moisture. It is important to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

White to grayish-white, flat, oblong, biconvex, extended-release film-coated tablets

Package unit

60 tablets (10 tablets/PTP × 6)