Hanin Quetiapine Extended-Release Tablet 300 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

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

This medication is primarily used for treating psychiatric disorders, particularly depression, schizophrenia, and bipolar disorder. While taking this medication, there may be an increased risk of suicidal thoughts or behaviors, particularly in young patients aged 18 to 24; therefore, careful judgment and continuous monitoring by physicians is necessary. Blood sugar levels may increase, or diabetes could worsen; thus, patients with diabetes or those at risk for diabetes should have regular blood sugar checks. Severe neurological side effects such as muscle stiffness, high fever, and changes in mental state may occur; if these symptoms appear, notify medical personnel immediately and stop using the medication. Long-term use may lead to movement disorders; if any abnormal symptoms occur, consider adjusting the dosage or discontinuation. Elderly patients with dementia may have an increased risk of death, so it is best not to use this medication in such cases. There is a risk of a sudden decrease in white blood cell count, necessitating attention to symptoms of infection and regular blood tests. Patients at risk of stroke should use this medication with special caution. There is a risk of thromboembolism; therefore, patients with risk factors for thromboembolism should be closely monitored before and during medication use. Patients with heart disease or low blood pressure may experience dizziness or orthostatic hypotension during initial dosing, so the dosage should be increased gradually, observing their condition. Severe allergic reactions may occur, so if symptoms such as rash, fever, or swelling of lymph nodes appear, immediately discontinue the medication and consult medical personnel. This medication is not administered to patients who are allergic to specific ingredients, in a state of coma, currently taking central nervous system depressants, receiving epinephrine, or have diabetes. Patients with impaired liver function, cardiovascular disease, a history of seizures, elderly individuals, and women who are pregnant or breastfeeding should use this medication cautiously. Common side effects include drowsiness, dizziness, dry mouth, weight gain, changes in blood lipids and blood sugar levels, among others. Activities requiring attention, such as driving or operating machinery, should be approached with caution according to individual differences after taking this medication. Abruptly discontinuing this medication may lead to withdrawal symptoms, so dosage should be gradually reduced under a doctor’s supervision when stopping. There may be drug interactions, so if currently taking other medications, inform your doctor or pharmacist. During pregnancy or breastfeeding, there may be impacts on the fetus or newborn; therefore, discussions with healthcare providers are necessary to decide on the use. This medication is not recommended for children or adolescents as safety and efficacy have not been established. In cases of overdose, severe drowsiness, low blood pressure, and heart abnormalities may occur, requiring immediate medical attention. This medication should be kept out of reach of children and not transferred to other containers for safety purposes.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, total cholesterol increase, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, weight gain, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disturbance, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, bowel obstruction, respiratory distress, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, elevated serum liver enzymes, eosinophilia, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, cutaneous vasculitis, drug reactions with eosinophilia and systemic symptoms, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 15°C and 30°C (room temperature).

Appearance

Light yellow, oblong, extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP × 6)