Hwanin Quetiapine Extended Release Tablet 400 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. 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 1 300 mg, Day 2 600 mg, Day 3 400～800 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 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 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 is primarily used to treat psychiatric conditions. While taking this medication, there may be an increase in suicidal thoughts or behavior, so careful monitoring by a physician is necessary, particularly for children, adolescents, and young adults. Patients with diabetes or at risk for hyperglycemia should regularly monitor blood glucose levels, and should consult healthcare professionals immediately if hyperglycemic symptoms occur. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome; if symptoms such as high fever, muscle rigidity, or changes in mental state appear, the medication should be discontinued immediately and treatment sought. Long-term use may lead to movement disorders like extrapyramidal symptoms or tardive dyskinesia, so consideration for dosage adjustment or discontinuation should be made if such symptoms arise. It is advised not to use this medication in elderly patients with dementia as it may increase the risk of death. Leukopenia, particularly severe neutropenia, may occur, so patients should inform healthcare professionals immediately if they experience symptoms of infection or fever. Patients with cardiovascular diseases, cerebrovascular diseases, or those at risk of hypotension need to be particularly cautious during initial administration, as symptoms like dizziness or fainting may occur. This medication can cause severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), so if skin rash, fever, or lymphadenopathy appears, medication should be stopped and a doctor consulted immediately. This medication should not be administered under certain circumstances, such as in patients with allergies to this product or its components, in those who are in a coma, in conjunction with certain neuroleptics, during administration of epinephrine, and in diabetic patients. Patients with impaired liver function or cardiovascular diseases, a history of epilepsy, elderly patients, pregnant women, and nursing mothers should use this medication with caution. Common side effects include drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, fainting, nightmares, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, blurred vision, and so on. There have also been reports of various adverse reactions such as seizures, changes in blood pressure, and changes in blood parameters; so if unusual symptoms present, immediate consultation with healthcare professionals is advised. This medication may cause increased drowsiness or decreased concentration when taken with other central nervous system medications or alcohol, so caution is needed. Especially when combined with strong liver enzyme inhibitors or inducers, the drug concentration may change, so always consult a physician regarding concomitant medications. Pregnant women should consult a doctor before use as this medication may affect the fetus and nursing mothers are advised to avoid breastfeeding while taking this medication. The safety and efficacy of this medication in children and adolescents have not been established, thus its use is not recommended. In case of overdose, immediate emergency treatment is necessary, and since there is no specific antidote, intensive care by medical professionals is required. Finally, this medication should be stored out of reach of children, and care should be taken not to transfer it to other containers.

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, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, respiratory distress, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, increased blood sugar levels to hyperglycemic levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, tardive dyskinesia, 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 avoid exposure to air or moisture, and it is important to keep it at room temperature between 15 and 30 degrees Celsius to maintain appropriate efficacy.

Appearance

White rectangular extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP × 6)