Han In Quetiapine Extended Release Tablets 200 mg (Quetiapine Fumarate)

Adult dose

This medicine is administered once daily in the evening. Swallow it 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). 1. Schizophrenia Adults: Start with 300 mg of quetiapine; adjust the dose to 400～800 mg per day 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. 2. Bipolar disorder - Acute treatment of manic or mixed episodes associated with bipolar I disorder Adults: As monotherapy or 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, the dose may be adjusted within 400～800 mg per day according to the clinical response and tolerability of each patient. Recommended dosing schedule Treatment day 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 Treatment day 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 responded to quetiapine treatment 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 per day according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. 3. Adjunctive treatment of major depressive disorder Adults: Start 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 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 switch to this medicine for convenience and take it once daily at the same total daily dose. Individual dose adjustment may be necessary. ○ Older adults: As with other antipsychotics, this medicine should be administered with caution to older adults, 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 older patients compared with adult patients. Older adults should start at 50 mg per day. Increase by 50 mg per day according to each patient's clinical response and tolerability until an effective dose is reached. ○ Patients with renal failure: After oral administration of this medicine, mean oral creatinine clearance is reduced by 25% in patients with severe renal failure (creatinine clearance 10～30 mL/min/1.73 m2) compared with adult patients; dose adjustment is generally not necessary. ○ Patients with hepatic failure: Since quetiapine is primarily metabolized in the liver, this medicine should be administered with caution to patients with hepatic failure, particularly when initiating treatment. Patients with hepatic failure should start at 50 mg per day; the dose may be increased by 50 mg per day according to each patient's clinical response and tolerability until an effective dose is reached.

Child dose

○ Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents 18 years of age or younger.

This medication is used for the treatment of psychiatric disorders, particularly to alleviate symptoms of schizophrenia or bipolar disorder. There may be an increased risk of suicidal thoughts or behaviors while taking this medication, especially in young patients aged 18 to 24 years, thus careful judgment and ongoing observation by a physician are required. There may be an increase in blood glucose levels, potentially worsening diabetes; therefore, patients with diabetes or risk factors should regularly monitor their blood sugar and carefully observe symptoms. Neuroleptic Malignant Syndrome, a serious side effect, can rarely occur, so if symptoms such as high fever, muscle rigidity, or changes in mental state appear, the doctor should be notified immediately. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, hence if any abnormal body movements occur, consultation with medical personnel is necessary. It is recommended not to use this medication in elderly patients with dementia, and caution should be exercised in patients with cardiovascular diseases or hypotension. Severe neutropenia or agranulocytosis may occur, so if any symptoms of infection or fever develop, immediate medical attention is required. This medication can cause orthostatic hypotension leading to dizziness or fainting, therefore special care should be taken to move slowly and pay careful attention to symptoms, especially when starting treatment or adjusting the dose. Anticholinergic effects may lead to symptoms such as dry mouth, constipation, and urinary retention; if these symptoms are severe, consultation with medical personnel is recommended. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as withdrawal symptoms may occur in newborns, requiring caution. Abrupt withdrawal of this medication may result in withdrawal symptoms such as nausea, vomiting, and insomnia, therefore it is important to gradually decrease the dose under a doctor's instructions when discontinuing. Caution is necessary regarding concurrent use of other central nervous system depressants or alcohol, as it may significantly worsen drowsiness or reduce concentration. Since this medication is metabolized in the liver, patients with impaired liver function should start at a lower dose and be closely monitored. In cases of overdose, symptoms may include severe drowsiness, hypotension, and tachycardia, requiring immediate emergency treatment if overdose is suspected. It is advisable to avoid driving or operating hazardous machinery during the course of treatment.

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, somnambulism, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, hyperirritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophil count, increased blood glucose levels, elevated serum prolactin, thrombocytopenia, 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 avoid contact with air or moisture. The storage temperature should be kept at room temperature between 15 to 30 degrees Celsius.

Appearance

Yellow oblong extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP×6)