Quetiapine Extended-Release Tablets 50 mg (Quetiapine Fumarate)

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). Schizophrenia Adults: Initiate treatment with quetiapine 300 mg. Adjust the dose to 400∼800 mg daily according to each patient's response and tolerability. The dose may be increased by up to 300 mg daily at intervals of 1 day. The safety of doses exceeding 800 mg daily 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. Initiate treatment with quetiapine 300 mg 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 daily according to each patient's clinical response and tolerability. Recommended dosing schedule Day 1: 300 mg Day 2: 600 mg Day 3: 400∼800 mg Acute treatment of depressive episodes associated with bipolar disorder Adults: This medicine is used as monotherapy. The daily dose of 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 Day 1: 50 mg Day 2: 100 mg Day 3: 200 mg Day 4: 300 mg Prevention of recurrence in patients who have responded to quetiapine treatment for manic, mixed, or depressive episodes For 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 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: Initiate treatment with 50 mg on Day 1 and increase to 150 mg on Day 3. The 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 quetiapine fumarate immediate-release tablets may be switched to this medicine for convenience of administration, with once-daily dosing 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 to 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 daily. Increase the dose by 50 mg daily according to each patient's clinical response and tolerability until an effective dose is reached. Patients with renal impairment: After oral administration of this medicine, the 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 necessary. Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, administer this medicine with caution to patients with hepatic impairment, particularly when initiating treatment. Initiate treatment in patients with hepatic impairment at a dose of 50 mg daily and increase the dose by 50 mg daily according to each patient's clinical response and tolerability until an effective dose is reached.

Child dose

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

This drug may increase the risk of suicidal thoughts and behaviors in young people with depression or psychiatric disorders, so physicians should evaluate the situation carefully before prescribing. This medication may elevate blood sugar, so patients with diabetes or risk factors should conduct regular blood sugar tests. Neuroleptic Malignant Syndrome, a severe condition characterized by muscle rigidity, high fever, and altered mental state, may occur rarely; if such symptoms appear, the medication should be discontinued immediately and treated. Prolonged use may lead to tardive dyskinesia, symptoms of abnormal movement in the body, so if symptoms appear, dosage adjustment or discontinuation should be considered. Elderly patients with dementia may have an increased risk of death, hence caution is needed when using this drug. Severe blood abnormalities such as agranulocytosis may occur, so regular monitoring of white blood cell counts is necessary, and immediate consultation with a physician is advised when symptoms of infection arise. Patients at risk for cerebrovascular diseases should be particularly careful, as they may have an increased risk of stroke. Due to the risk of thrombosis, risk factors for thrombosis should be assessed and preventive measures taken. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension and dizziness during initial dosing, so care should be exercised. Severe skin reactions may occur, so if symptoms like rash or fever appear, medication should be discontinued immediately. This drug is not to be used in individuals with specific allergies, comatose patients, those taking certain central nervous system depressants, individuals receiving epinephrine, diabetic patients, or lactose intolerant patients. Caution is advised when prescribing to patients with impaired liver function, those with cardiovascular diseases, patients with a history of seizures, the elderly, those at risk of suicide, as well as pregnant and breastfeeding women. Common side effects during treatment include drowsiness, dizziness, dry mouth, weight gain, changes in blood sugar, and lipid levels; consult a physician if symptoms are severe. This medication may cause withdrawal symptoms when abruptly stopped, so it should be gradually tapered off. Caution is needed while driving or operating machinery, and special care should be taken when taken with other central nervous system depressants or alcohol. Use during pregnancy may affect the fetus, and withdrawal symptoms may appear in newborns, so pregnant women should discuss treatment with their physician before use. In breastfeeding women, this medication can be transmitted through breast milk, so it is advisable to avoid breastfeeding. Overdose may lead to severe drowsiness, sedation, and hypotension, requiring emergency treatment. The safety and efficacy of this drug have not been established in children and adolescents.

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, dizziness, headache, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to sleepwalking, dry mouth, constipation, indigestion, vomiting, dysphagia, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity, anaphylactic reactions, blurred vision, pain in the back, myalgia, rhabdomyolysis, persistent erection, galactorrhea, increased appetite, withdrawal symptoms, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, neuroleptic malignant syndrome, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, increased blood glucose to hyperglycemic 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 with eosinophilia and systemic symptoms, skin vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to keep the drug at room temperature between 15 and 30 degrees Celsius. Avoid places that are too hot or too cold, and store it in a cool place away from direct sunlight.

Appearance

White to grayish-white, double-convex, round, extended-release film-coated tablets

Package unit

60 tablets (10 tablets/PTP × 6)