Myungmoon Quetiapine Tablets 25 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medication is taken twice daily, regardless of meals. 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. 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 adult patients with schizophrenia. Patients should be reassessed regularly to determine whether maintenance therapy is needed. Acute treatment of manic episodes associated with bipolar I disorder Adults: This medication is taken twice daily, regardless of meals. 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, with increases of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder Adults: This medication is taken once daily at bedtime, regardless of meals. 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 the 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 with 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. In patients who tolerate the medication, reduction to as low as 200 mg has been 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 300～800 mg/day, given twice daily. It is important to use the minimum effective dose for maintenance therapy. Older adults: As with other antipsychotics, this medication should be administered with caution to older adults, particularly when starting treatment. Older patients should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day; the effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because quetiapine is primarily metabolized in the liver, it should be administered cautiously to patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

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

This medication is primarily used for treating psychiatric disorders and should be used cautiously in young patients with suicidal tendencies. In particular, patients aged 18 to 24 may have an increased risk of suicidal thoughts and behaviors, so the physician should carefully consider the necessity and risks of treatment. This medication can increase blood glucose levels, so diabetic patients or those at risk of diabetes should regularly monitor their blood sugar before taking this medication, and patients and their families should be adequately informed about hyperglycemic symptoms. Serious side effects such as Neuroleptic Malignant Syndrome may occur, so if symptoms like high fever, muscle rigidity, or changes in mental status occur, medication should be stopped immediately and healthcare professionals should be notified. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if unusual symptoms arise, dosing adjustments or discontinuation should be considered after consulting a doctor. Use of this drug in elderly patients with dementia may increase the risk of death, so special caution is required. A decrease in blood cell count, particularly severe neutropenia or agranulocytosis, may occur, thus regular monitoring of white blood cell count is necessary, and treatment should be initiated immediately if any signs of infection appear. Patients with a history of cerebrovascular disease or cardiovascular disease should be cautious when using this medication due to the increased risk of stroke. This drug may cause orthostatic hypotension, requiring dosing adjustments or consultation with healthcare professionals if symptoms such as dizziness or fainting occur. Severe skin reactions like Stevens-Johnson Syndrome or toxic epidermal necrolysis have been rarely reported, so if symptoms such as skin rash or fever occur, discontinuation of the medication should be immediate. Specific patient groups, such as patients with lactose intolerance, patients in a comatose state, patients taking central nervous system depressants, patients administered epinephrine, and those with diabetes should avoid using this medication. Patients with impaired liver function, the elderly, those at risk for suicide, or individuals with a family history of diabetes or obesity-related risk factors should start at lower doses and be closely monitored. Women who are pregnant or breastfeeding should consult a doctor before using this medication, as it may cause adverse effects in the fetus or newborn. This drug may produce various side effects such as drowsiness, dizziness, dry mouth, and weight gain, and caution should be exercised when driving or operating dangerous machinery. In cases of overdose, severe drowsiness, low blood pressure, and anticholinergic symptoms may occur, so immediate medical attention is necessary. This medication may interact with other drugs, so especially when taken with liver enzyme inducers or inhibitors, or serotonergic drugs, the doctor should be informed and caution taken. Lastly, this medication is not recommended for use in children or adolescents, as safety and efficacy have not been established.

• 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 prevent exposure to air and moisture and kept in a cool place below 30 degrees Celsius. This is to maintain the drug's effectiveness and prevent degradation.

Appearance

Pink round film-coated tablets

Package unit

Domestic - 30 tablets/bottle, Domestic - 100 tablets/bottle, Export - 30 tablets/bottle, Export - 100 tablets/bottle, Export - 30 tablets/box [10 tablets/PTP *3]