Smoofin Tablets 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This drug 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, 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 tolerability. - Maintenance therapy has not been evaluated in adults 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 drug is taken 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, 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 tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: This drug 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 confirmatory clinical trials of this drug, 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 drug, reduction to a minimum of 200 mg has been shown to be possible in clinical trials. (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 in acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and individual tolerability, the twice-daily dose may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults : As with other antipsychotics, this drug should be administered with caution to older adults, particularly when initiating treatment. Older patients should start 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. 5. Patients with renal and hepatic impairment : Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. As quetiapine is primarily metabolized in the liver, use with caution in patients with known hepatic impairment. Patients with renal or hepatic impairment should start 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 in children and adolescents have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in young individuals with major depressive disorder or psychiatric conditions, thus thorough consultation with a physician and careful monitoring are necessary before administration. This medication may increase blood sugar levels, so patients with diabetes or at risk for diabetes should regularly check their blood sugar and monitor symptoms. A serious side effect known as Neuroleptic Malignant Syndrome may occur rarely, and if symptoms such as high fever, muscle rigidity, and mental changes occur, immediate medical attention is required. With long-term use, extrapyramidal symptoms or tardive dyskinesia may develop, and if abnormal symptoms appear, dose adjustment or discontinuation should be considered. It is advisable not to use this medication in elderly patients with dementia, considering the increased risk of death. A decrease in blood cell counts, particularly neutropenia, may occur; thus, immediate medical consultation is needed if symptoms of infection or fever arise, and regular blood tests are necessary. Caution is required for patients at risk of cerebrovascular disease, and there is also a risk of venous thrombosis, so risk factors for thrombosis should be identified and preventive measures taken. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension upon initial administration, so the dose should be adjusted slowly while monitoring the patient's condition. There is a risk of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis; thus, if symptoms such as rashes or fever occur, the medication should be discontinued immediately and a doctor consulted. This medication should not be given to patients with specific allergies or comatose states, and women who are pregnant or breastfeeding should use it cautiously after consulting a physician. Drowsiness, dizziness, dry mouth, and other symptoms may commonly occur during treatment; therefore, caution should be taken when driving or operating machinery, and abrupt discontinuation should be avoided as it may lead to withdrawal symptoms requiring gradual tapering. There is a possibility of drug interactions, so if taking other medications, it is essential to inform healthcare providers, especially when using central nervous system depressants or CYP3A4 inhibitors.

• 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 closed container to prevent exposure to air or moisture, and it should be kept in a cool place below 30 degrees. This storage condition helps maintain the medication's effectiveness for a longer period.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTPX3], 100 tablets/bottle