Akyumin Tablet 100 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: Take this medicine twice daily, with or without food. The total daily dose for the first 4 days is 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. From Day 4 onward, adjust to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and drug tolerability. Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. As monotherapy or adjunctive therapy to a mood stabilizer (lithium or valproate), the total daily dose for the first 4 days is 100 mg on Day 1, 200 mg on Day 2, 300 mg on Day 3, and 400 mg on Day 4. The total daily dose may be increased to 800 mg by Day 6, in increments of no more than 200mg per day. Depending on each patient's clinical response and drug tolerability, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder: Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose for the first 4 days should reach 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. In confirmatory clinical trials of this medicine, doses of 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, 300 mg on Day 4, 400 mg on Day 5, and up to 600 mg on Day 8 were administered. The recommended daily dose is 300 mg. Antidepressant effects were observed with both 300 mg and 600 mg, but there was no additional benefit with 600 mg. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, reduction to as low as 200 mg was shown to be possible in clinical trials. Prevention of recurrence of bipolar disorder: Adults: 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. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. Older adults As with other antipsychotics, this medicine should be administered cautiously to older adults, particularly at the start of treatment. Older patients should start with 25 mg/day of this medicine, with gradual increases of 25～50 mg daily; the effective dose in older adults may be lower than that in younger patients. Patients with renal and hepatic impairment Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal and hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer cautiously to patients with known hepatic dysfunction. Patients with renal and hepatic impairment should start with 25 mg/day of this medicine and gradually increase by 25～50 mg daily to the effective dose.

Child dose

Safety and efficacy in pediatric and adolescent patients have not been established.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders; therefore, when administering it to patients in these age groups, the physician should carefully assess the risks and benefits. Adverse reactions related to hyperglycemia or diabetes have been reported, so particularly for patients with diabetes or risk factors for diabetes, blood sugar levels should be checked regularly, and symptoms of hyperglycemia should be monitored closely. A rare but serious side effect known as Neuroleptic Malignant Syndrome may occur, which can be accompanied by high fever, muscle rigidity, and changes in mental state; therefore, if symptoms occur, drug administration should be immediately discontinued and appropriate treatment should be initiated. Prolonged use may lead to tardive dyskinesia, which is an involuntary movement disorder; therefore, if symptoms appear, dose adjustment or discontinuation should be considered. In dementia patients, the risk of death may be increased when using this medication, so it is recommended not to use this medication for the treatment of dementia-related psychosis. Blood abnormalities such as agranulocytosis or severe neutropenia may occur, so if white blood cell counts drop, treatment should be discontinued, and symptoms of infection should be monitored. The risk of cerebrovascular diseases may increase, so caution is particularly advised in patients with risk factors for stroke when using this medication. There is a possibility of venous thromboembolism occurring, so patients with risk factors for thrombosis should be verified and preventive measures should be taken in advance. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension, thus initial dose adjustments and monitoring of the patient's condition are necessary. Severe cutaneous adverse reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been rarely reported; if symptoms such as skin rash or fever appear, drug administration should be immediately discontinued. This medication may be risky when combined with certain central nervous system depressants or epinephrine; therefore, co-administration should be avoided. Pregnant or breastfeeding women may experience side effects in the fetus or newborn when using this medication; hence, risks and benefits to the fetus should be carefully considered, and breastfeeding is recommended to be avoided. Elderly patients may have higher body concentrations of this medication and an increased risk of orthostatic hypotension; therefore, starting with a low dose and gradually increasing while closely monitoring the patient's condition is essential. Abrupt discontinuation of this medication may result in withdrawal symptoms or a recurrence of psychotic symptoms; therefore, it is safe to gradually taper the dose before discontinuation. Common side effects of this medication may include drowsiness, dizziness, dry mouth, weight gain, and attention should be paid when operating vehicles or dangerous machinery. Taking this medication in combination with other central nervous system depressants or alcohol may increase side effects, thus caution is needed during co-administration. This medication may interact with various other drugs, so if there are any other medications being taken, it is essential to inform the physician or pharmacist.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglycerides
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, ideally kept in a cool place below 30 degrees. This will help maintain the effectiveness of the medication and prevent deterioration.

Appearance

Yellow circular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle