Caspeen Tablets 300 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 dose of 300～400 mg daily. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 150～750 mg/day. 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. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depressive episodes associated with bipolar disorder: Adults: This drug is taken once daily at bedtime, with or without food. The total daily dose 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 with both 300 mg and 600 mg, but there was no additional benefit at 600 mg. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, 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 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, administered twice daily. 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 starting treatment. Older patients should start this drug 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 or hepatic impairment After oral administration of quetiapine, clearance is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, it should be administered with caution in patients with known hepatic impairment. Patients with renal or hepatic impairment should start this drug 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 may increase the risk of suicidal thoughts or behaviors in young patients with major depression or psychiatric disorders, requiring careful observation. Since high blood sugar can lead to diabetes or hyperglycemia-related complications, patients with diabetes or risk factors should regularly check their blood sugar. During the use of this medication, serious side effects such as Neuroleptic Malignant Syndrome may rarely occur; immediate consultation with medical personnel is recommended if high fever, muscle rigidity, or changes in mental state occur. Long-term use can lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so patients should consult a doctor if symptoms appear. In elderly patients with dementia, there may be an increased risk of death, so the use of this medication is not recommended. There is a risk of severe neutropenia or agranulocytosis, which may lead to a sudden drop in blood cell counts; monitoring for infection symptoms and regular blood testing are necessary. For patients at risk of cerebrovascular disease, there may be an increased risk of stroke, requiring careful use. Due to the risk of venous thromboembolism, patients with risk factors for thrombosis should take preventive measures and be closely monitored. Patients with cardiovascular diseases or hypotension should be especially cautious for dizziness or fainting related to orthostatic hypotension during initial administration. Severe skin reactions such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis may occur; in cases of extensive skin rash or fever, immediate discontinuation of the medication and notification of medical personnel are necessary. This medication should not be administered to patients with specific genetic lactose metabolism disorders, patients in a comatose state, or those taking certain central nervous system depressants concurrently. Patients with impaired liver function should start at a low dose and be closely monitored. Pregnant or breastfeeding women should use with caution due to potential effects on the fetus or newborn; particularly in late pregnancy, withdrawal symptoms may appear in the newborn. Elderly patients have slowed drug metabolism, so they should start on a lower dose and gradually increase while being cautioned for side effects. In case of overdose, severe drowsiness, hypotension, tachycardia, etc., may occur, requiring immediate emergency treatment. Since this medication can cause drowsiness and dizziness, caution is needed when driving or operating hazardous machinery. Additionally, this medication has many drug interactions, so if other medications are being taken, it is essential to consult a doctor or pharmacist.

• 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, preferably in a cool place below 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a long time.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle