Hanin Quetiapine Extended-Release Tablets 50 mg (Quetiapine Fumarate)

Adult dose

This medicine should be administered 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 300 mg of quetiapine. Adjust the dose within the range of 400～800 mg once daily 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 involving patients with schizophrenia who had been stabilized after receiving this medicine for 16 weeks, and who were treated for 1 year or until relapse, this medicine was effective in prolonging the time to relapse. 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. Initiate treatment with 300 mg of quetiapine on Day 1, increase the dose to 600 mg on Day 2, and from Day 3 onward, adjust the dose within the range of 400～800 mg once daily according to each patient's clinical response and drug 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 this medicine should be 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 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 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 treatment at the same dose. The dose may be adjusted within the range of 300～800 mg once daily according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. 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 doses of 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, with once-daily administration 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. 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 once daily. 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, 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: As quetiapine is primarily metabolized in the liver, this medicine 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 once daily. The dose may be increased 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 medication have not been established in children and adolescents 18 years of age or younger.

This medication is primarily used to treat psychiatric disorders, particularly symptoms such as depression or schizophrenia. While taking this medication, there may be an increased risk of suicidal thoughts or behaviors, so especially children, adolescents, and young adults require careful judgment and continuous monitoring by a physician. There may be a risk of increased blood sugar levels, so patients with diabetes or a family history of diabetes should regularly monitor blood sugar and carefully observe symptoms. If symptoms such as severe muscle rigidity, high fever, or changes in mental state occur, immediate consultation with healthcare professionals is necessary, as these symptoms may indicate neuroleptic malignant syndrome. Prolonged use may result in tardive dyskinesia, a type of involuntary movement disorder, so adjustments in dosage or discontinuation should be considered if unusual symptoms occur. Elderly patients with dementia may face an increased risk of death, so special caution is necessary, and this medication is not approved for the treatment of dementia-related psychosis. There may be a rapid decrease in blood cell counts leading to severe neutropenia or agranulocytosis, so immediate notification to a hospital is required if infection symptoms or fever occur. Patients at risk of cerebrovascular disease may have an increased risk of stroke, so caution is advised when using. There is a risk of thromboembolism, so it is essential to identify any risk factors for venous thromboembolism and take preventive measures. Patients with cardiovascular diseases or hypotension require initial dose adjustments and monitoring, and should be cautious of symptoms of orthostatic hypotension. Rarely, severe skin reactions may occur, so if symptoms like skin rash or fever appear, immediate discontinuation of the medication and consultation with healthcare professionals are necessary. This medication is not to be administered to specific allergic patients, those in a comatose state, those taking certain central nervous system depressants, those undergoing epinephrine administration, diabetic patients, or those with lactose intolerance. Patients with impaired liver function, cardiovascular disease, cerebrovascular disease, history of seizures, elderly patients, those at risk of suicide, pregnant or potentially pregnant women, and nursing mothers should be administered with caution. Symptoms such as drowsiness, dizziness, dry mouth, weight gain, changes in blood lipids, extrapyramidal symptoms, speech difficulties, restless legs syndrome, fainting, nightmares, sleepwalking, constipation, indigestion, vomiting, swallowing difficulties, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, blurred vision, and pain in various areas may occur, and healthcare professionals should be consulted if these symptoms arise. This medication affects the central nervous system, potentially causing drowsiness or decreased concentration, so it is advisable to avoid driving or operating machinery during initial usage. Abruptly discontinuing the medication may lead to withdrawal symptoms such as nausea, vomiting, and insomnia, so it should be tapered off gradually. There may be interactions with other medications, so it is crucial to inform healthcare professionals if other medications are being taken, particularly with potent liver enzyme inhibitors or central nervous system depressants. During pregnancy, the medication may affect the fetus, so its use should only be considered when the benefits outweigh the risks for the fetus, and nursing mothers are advised to avoid breastfeeding. Safety and efficacy in children and adolescents under 18 years have not been established, therefore, it is not recommended. In case of overdose, symptoms such as drowsiness, sedation, and hypotension may present, and appropriate treatment according to the symptoms is necessary, as there is no specific antidote. This medication should be stored out of reach of children and should not be transferred 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, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophil count, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thrombosis, fatigue, visual disturbances

This medication should be stored in a sealed container to protect it from exposure to air or moisture. Additionally, it is advisable to store it at room temperature between 15 degrees and 30 degrees Celsius.

Appearance

Pink rectangular extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP × 6)