Mirae Quetiapine Tablets 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medication is taken 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medication is taken twice daily, with or without food. As monotherapy or as 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/day. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day, and the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medication is taken 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 pivotal clinical trials of this medication, 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 at both 300 mg and 600 mg, but there was no additional benefit at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For patients who tolerate the medication, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. (3) 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 for 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 lowest effective dose for maintenance therapy. 3. Older adults As with other antipsychotics, this medication should be administered with caution in older adults, particularly when initiating treatment. Older patients should start treatment with 25 mg/day, with gradual increases of 25～50 mg/day; the effective dose in older adults may be lower than that in younger patients. 5. Patients with renal and hepatic impairment After oral administration of quetiapine, clearance is reduced by approximately 25% in patients with renal and hepatic impairment. Since quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Patients with renal and hepatic impairment should start treatment with 25 mg/day, with gradual increases of 25～50 mg/day until an effective dose is reached.

Child dose

Children and adolescents: The safety and efficacy of this medication have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behavior in young individuals with major depressive disorder or psychiatric illnesses; therefore, careful evaluation by a physician and close monitoring of the patient's status is required during treatment. Some patients taking this medication may experience elevated blood sugar levels, and those with diabetes or risk factors for diabetes should regularly check their blood sugar levels. This medication can rarely cause a serious condition known as Neuroleptic Malignant Syndrome (NMS), which includes high fever, muscle rigidity, and changes in mental state. If these symptoms occur, medical assistance should be sought immediately. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, necessitating consideration of dosage adjustment or discontinuation if abnormal symptoms arise. It is recommended that this medication not be used in elderly patients with dementia due to an increased risk of death. Blood abnormalities such as severe neutropenia or agranulocytosis may occur; thus, white blood cell counts should be monitored regularly, and immediate treatment should be initiated if infection symptoms are present. Caution should be exercised in patients at risk for cerebrovascular diseases, as there may be an increased risk of stroke. There is a risk of venous thromboembolism, so patients with thrombotic risk factors should be closely monitored before and after treatment. Patients with cardiovascular diseases or hypotension should be particularly careful during the initial titration period due to the possibility of dizziness or orthostatic hypotension. This medication can rarely lead to serious skin reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug hypersensitivity. If symptoms such as skin rash or fever occur, the medication should be discontinued immediately and medical advice sought. This medication should not be administered to patients with hypersensitivity to it, those in a comatose state, or when used in conjunction with central nervous system depressants, epinephrine, diabetic patients, or those with certain genetic lactose intolerance. Patients with liver function impairment should start with a low dose and be carefully monitored while gradually increasing the dose. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may affect the fetus or newborn, and it is advised to avoid taking this medication while breastfeeding. This medication may cause various side effects such as sedation, dizziness, dry mouth, weight gain, extrapyramidal symptoms, etc. Therefore, it is important to consult a medical professional if abnormal symptoms occur. In case of drug overdose, there are no specific antidotes; intensive monitoring of respiratory and cardiac status is needed, along with necessary emergency measures. Taking this medication with other central nervous system depressants or alcohol may significantly increase drowsiness and decreased concentration, so caution should be exercised when combining. Drowsiness or decreased attention may occur while driving or operating hazardous machinery, so caution is needed. Regular blood tests, blood sugar checks, liver function tests, etc., should be conducted during treatment to identify and manage any adverse reactions early.

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

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture, and it is best kept in a cool place below 30 degrees Celsius. This will help to maintain the effectiveness of the medication for a longer period.

Appearance

Round pink film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle