Hwanin Quetiapine Extended-Release Tablets 150 mg (Quetiapine Fumarate)

Adult dose

This medicine should be taken 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: Start treatment with 300 mg of quetiapine. Adjust the dose within 400～800 mg once daily according to the individual 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 involving patients with schizophrenia who had been 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. 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. Start with 300 mg of quetiapine on Day 1 and increase to 600 mg on Day 2. From Day 3 onward, the dose may be adjusted within 400～800 mg once daily according to the individual patient's clinical response and tolerability. Recommended dosing schedule Day of treatment 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 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 of treatment 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 for manic, mixed, or depressive episodes To prevent 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 300～800 mg once daily according to clinical response and individual tolerability. It is important to use the lowest effective dose for maintenance therapy. Adjunctive treatment of major depressive disorder Adults: Start this medicine at 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 once daily. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg once daily have not been studied. Switching from immediate-release tablets: Patients taking immediate-release quetiapine fumarate tablets may switch to this medicine for convenience and take 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 used 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. Start elderly patients at 50 mg once daily. Increase the dose by 50 mg per day 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 creatinine clearance is reduced by 25% in patients with severe renal impairment (creatinine clearance 10～30 mL/min/1.73 m2) compared with adult patients; however, dose adjustment is generally not required. Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, use this medicine with caution in patients with hepatic impairment, particularly when initiating treatment. Start patients with hepatic impairment at 50 mg once daily and increase the dose by 50 mg per day until an effective dose is reached, according to the individual patient's clinical response and tolerability.

Child dose

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

This medication may increase the risk of suicidal thoughts or behavior, so it should be used with caution, especially in young patients between the ages of 18 and 24. This medication may elevate blood sugar levels, requiring patients with diabetes or risk factors for diabetes to regularly monitor their blood sugar. A serious side effect known as neuroleptic malignant syndrome can occur, so if symptoms such as high fever, muscle rigidity, or changes in consciousness appear, immediate medical attention is required. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, and if abnormal symptoms occur, dosage adjustment or discontinuation should be considered. It is advisable not to use this medication in elderly patients with dementia due to the potential increased risk of death. Severe neutropenia or agranulocytosis may occur, so white blood cell counts should be regularly monitored, and treatment is required immediately if infection symptoms appear. There may be an increased risk of cerebrovascular disease, so patients with risk factors for stroke should be particularly cautious. There is a risk of venous thrombosis, so patients with risk factors for thrombosis should implement preventive measures. Patients with cardiovascular diseases or hypotension should be cautious of orthostatic hypotension or dizziness during initial dosing and should be closely monitored. Severe skin adverse reactions may occur, so if symptoms such as rash, fever, or lymphadenopathy appear, the medication should be stopped immediately. This medication should not be administered to certain patients, such as those allergic to this medication or its components, those in a coma, patients taking central nervous system depressants such as barbiturates, patients receiving epinephrine, and patients with diabetes. Patients with liver dysfunction or cardiovascular disease, cerebrovascular disease, or hypotension should start at a low dose and be carefully monitored during treatment. Women who are pregnant or may become pregnant, and nursing mothers should consult a specialist and decide cautiously, as this medication may affect the fetus or newborn. This medication may cause drowsiness, dizziness, or decreased attention, so driving or operating machinery should be avoided. Caution should be taken not to combine with other central nervous system depressants or alcohol, as side effects may worsen. In case of overdose, symptoms such as severe hypotension, drowsiness, sedation, and tachycardia may appear, requiring immediate medical treatment. Changes in weight, blood sugar levels, and lipid values may occur during the use of this medication, so regular health check-ups and lifestyle management are necessary. Sudden discontinuation may trigger withdrawal symptoms, so dosage should be gradually reduced according to a doctor's instructions. If during treatment with this medication, suicidal thoughts or behavior, aggression, rage, or other abnormal behavioral changes occur, immediate consultation with healthcare providers is required.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, malignant neuroleptic syndrome, leukopenia, neutropenia, peripheral edema, dysarthria, 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 limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, elevated serum liver enzymes, increased eosinophils, elevated blood glucose levels, 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, thrombosis, fatigue, visual disturbances

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 15 and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance

White rectangular extended-release film-coated tablets

Package unit

60 tablets (10 tablets/PTP × 6)