Quetiapine Fumarate Extended-Release Tablets 200 mg

Adult dose

This medication is administered once daily in the evening. It must be swallowed whole and must not be split, chewed, or crushed. Avoid taking this medication 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 per day according to the response and tolerability of each patient. The dose may be increased by up to 300 mg per day at 1-day intervals. The safety of doses exceeding 800 mg per day has not been evaluated in clinical trials. 2. Bipolar disorder - Acute treatment of manic or mixed episodes associated with bipolar I disorder Adults: This medication is administered 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 per day according to the clinical response and tolerability of each patient. Recommended dosing schedule Day of treatment Day 1 Day 2 Day 3 Dose of this medication 300 mg 600 mg 400∼800 mg - Acute treatment of depressive episodes associated with bipolar disorder Adults: This medication is administered as monotherapy at a daily dose of 50 mg of quetiapine on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. Recommended dosing schedule Day of treatment Day 1 Day 2 Day 3 Day 4 Dose of this medication 50 mg 100 mg 200 mg 300 mg - Prevention of recurrence in patients who responded to quetiapine treatment for manic, mixed, or depressive episodes For the prevention of recurrence of manic, mixed, or depressive episodes 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 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 to 150 mg on day 3. The efficacy of this medication 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 be switched to this medication for convenience, with once-daily administration at the same total daily dose. Individual dose adjustment may be necessary. ○ Elderly patients: As with other antipsychotics, this medication 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. 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 a dose of 50 mg per day. Increase the dose by 50 mg per day until an effective dose is reached, according to the clinical response and tolerability of each patient. ○ Patients with renal impairment: Following oral administration of this medication, mean oral creatinine 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: Because quetiapine is primarily metabolized in the liver, this medication should be administered with caution to patients with hepatic impairment, particularly when initiating treatment. Initiate treatment in patients with hepatic impairment at a dose of 50 mg per day and increase the dose by 50 mg per day until an effective dose is reached, according to the clinical response and tolerability of each patient.

Child dose

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

This drug may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so caution is needed when using it. Patients with diabetes or at risk for diabetes should carefully monitor their blood sugar control status. This medication can cause a rare and severe side effect known as neuroleptic malignant syndrome, so if high fever, muscle rigidity, or changes in mental state occur, it is important to consult a healthcare professional immediately. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia; therefore, dosage adjustment or discontinuation should be considered if symptoms occur. Use in elderly patients with dementia is not recommended as it may increase the risk of death. Blood dyscrasias such as severe neutropenia or agranulocytosis may occur, so regular monitoring of white blood cell counts is necessary. Special caution is needed when administering to patients at risk for cerebrovascular disease due to the possibility of stroke. There is a risk of venous thromboembolism; therefore, patients with thrombotic risk factors should confirm and take preventive measures before using this medication. Patients with cardiovascular disease or at risk of hypotension should be cautious of orthostatic hypotension and dizziness during the initial administration. Severe skin adverse reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) can occur rarely, so if symptoms such as skin rash or fever develop, the medication should be discontinued immediately, and a healthcare provider should be consulted. Additionally, this drug should not be administered to patients with specific diseases or conditions, such as those in a coma, those taking barbiturates, those receiving epinephrine, and those with hereditary lactose intolerance. Caution should be exercised when administering to patients with liver impairment, elderly patients, those at risk of suicide, and pregnant or nursing women. It is advisable to start with a low dose and closely monitor the condition if necessary. Various side effects may occur during the use of this medication, including drowsiness, dizziness, dry mouth, weight gain, changes in blood sugar and lipid levels, so consulting a healthcare provider when symptoms develop is important. During treatment, it is advisable to avoid activities that require attention, such as driving or operating machinery, and exercise additional caution when taking other central nervous system depressants or alcohol. This drug may interact with several other medications, so it is essential to inform your healthcare provider if you are taking any other medications, particularly strong liver enzyme inhibitors or inducers, as dosage adjustment may be necessary. Pregnant or nursing women should consult their doctor before taking this medication, as it may affect the fetus or newborn. This medication is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established. In the case of overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may appear, and immediate emergency treatment is required; there is no specific antidote. Store this medication in a place out of reach of children, and do not transfer it to another container.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, weight gain, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disorder, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, shortness of breath, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, 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, decreased hemoglobin, increased serum liver enzymes, decreased neutrophils, increased eosinophils, increased blood sugar levels to hyperglycemic levels, increased serum prolactin, decreased total T4, decreased unbound T4, decreased total T3, increased TSH, increased AST, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, hepatic failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, skin vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to keep the storage temperature between 15 to 30 degrees Celsius. This helps maintain the medication's effectiveness.

Appearance

White to grayish-white, double-convex, rectangular extended-release film-coated tablet.

Package unit

60 tablets (10 tablets/ PTB packaging × 6)