Quetiapine Tablet 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

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

This medication is primarily used for the treatment of psychiatric disorders, particularly prescribed for depression, schizophrenia, and bipolar disorder. There may be an increased risk of suicidal thoughts or behaviors while taking this medication, especially in young patients aged 18 to 24, who should be closely monitored. Blood sugar levels may rise, so patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar and be alert for symptoms of hyperglycemia, such as thirst or frequent urination. Rare side effects like neuroleptic malignant syndrome may occur, characterized by high fever, muscle rigidity, and altered consciousness, necessitating immediate cessation of the medication and a visit to the hospital. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia; if strange movements or muscle spasms occur, consult a doctor. Elderly patients with dementia may face an increased risk of death; hence caution is warranted. Severe neutropenia or agranulocytosis, which can lead to a rapid decrease in white blood cell count, may rarely occur, requiring attention to infection symptoms and regular blood tests. Patients with cerebrovascular diseases or cardiovascular diseases may have an increased risk of strokes; thus, they need careful monitoring. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis need to be cautious before and after taking this medication. This medication may cause orthostatic hypotension, leading to dizziness or fainting, so patients should move slowly when first starting or adjusting their dose and observe for symptoms. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, requiring immediate notification to a doctor if symptoms like rash, skin peeling, or fever occur. Additionally, this medication is not administered to patients with allergies to certain components, those in a coma, or those taking CNS depressants such as barbiturates, patients receiving epinephrine, patients with diabetes, and those who are lactose intolerant. Patients with impaired liver function, cardiovascular disease, cerebrovascular disease, risks for hypotension, seizure history, the elderly, pregnant women, and nursing mothers should use this medication cautiously, starting at a lower dose and closely monitoring their condition. Side effects may include drowsiness, dizziness, dry mouth, weight gain, increased lipid levels, extrapyramidal symptoms, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, fainting, nightmares, symptoms related to sleepwalking, constipation, indigestion, vomiting, difficulty swallowing, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity, and blurred vision, so if these symptoms occur, patients should consult their healthcare professional. During treatment, avoid alcohol or other CNS depressants, and as drug interactions may occur, inform the doctor if other medications are being taken. Women who are pregnant or may become pregnant should consult a doctor before taking this medication due to potential effects on the fetus, and nursing mothers should avoid breastfeeding while on this medication. This medication is not recommended for children and adolescents due to lack of established safety and efficacy. In case of overdose, severe drowsiness, sedation, hypotension, and tachycardia may occur, necessitating emergency treatment. Keep this medication out of reach of children and do not transfer it to another container for safety. While taking this medication, caution should be exercised while driving or operating dangerous machinery, and any unusual symptoms or suspected side effects should be discussed with a healthcare professional immediately.

• 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 is important to keep it at a cool temperature below 30 degrees Celsius. This will help maintain the effectiveness of the medication and prevent deterioration.

Appearance

Pink round film-coated tablet

Package unit

[Domestic] 30 tablets/bottle, 100 tablets/bottle [Export] 30 tablets (10 tablets/PTP x3), 100 tablets (10 tablets/PTP x10)