Capsipine Tablet 25 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medicine 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 each patient's clinical response and tolerability, 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 whether maintenance therapy is needed. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medicine 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 200 mg per day. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medicine 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 the pivotal clinical trials of this medicine, 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 with 600 mg. Increases to doses above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For patients who tolerate the medicine, dose reduction to at least 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on the 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 minimum effective dose for maintenance therapy. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting treatment. Treatment should be initiated at 25 mg/day, with gradual daily increases of 25～50 mg. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment The oral clearance of quetiapine 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 to patients with known hepatic impairment. In patients with renal or hepatic impairment, treatment should be initiated at 25 mg/day, with gradual daily increases of 25～50 mg until the effective dose is reached.

This medication may increase the risk of suicidal thoughts or behavior in young people with major depressive disorder or psychiatric conditions, so it should be used with caution, especially in children, adolescents, and young adults. In addition, this medication can increase blood sugar levels, thus patients with diabetes or those at risk for diabetes should regularly monitor and manage their blood sugar levels. A rare but severe side effect known as Neuroleptic Malignant Syndrome may occur, so if symptoms such as high fever, muscle rigidity, or changes in mental state appear, medical attention should be sought immediately. Long-term use may cause extrapyramidal symptoms or tardive dyskinesia, and if these movement abnormality symptoms occur, the physician should be consulted. The use of this drug in elderly patients with dementia may increase the risk of death, thus it is not recommended. Serious agranulocytosis or neutropenia can occur, requiring regular monitoring of white blood cell counts and attention to infection symptoms. Patients with cerebrovascular disease or cardiovascular disease may have an increased risk of stroke when using this medication, requiring particular attention. There is a risk of venous thromboembolism; hence, patients with thrombotic risk factors should verify and take preventive measures beforehand. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension, thus caution is needed and dosing should start at a lower dose. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur, so if symptoms such as rash or fever appear, immediate discontinuation and consultation with healthcare professionals is necessary. This medication should not be administered to patients with specific conditions or states such as coma, under treatment with central nervous system depressants, receiving epinephrine, diabetic patients, and those with lactose intolerance. Patients with hepatic impairment, the elderly, cardiovascular disease, those at risk for suicide, and pregnant or breastfeeding women should use this medication with caution and require dosing adjustments and monitoring. Abrupt discontinuation of this medication may lead to withdrawal symptoms or worsening of symptoms, so it should be tapered down gradually according to the physician's instructions. This drug may cause increased drowsiness or concentration decrease if taken with other central nervous system medications or alcohol, so caution is advised. Pregnant or breastfeeding women should consult a doctor before use, as it may affect the fetus or newborn. In case of overdose, symptoms such as drowsiness, hypotension, and cardiac arrhythmia may occur, and specific antidotes are not available, necessitating immediate emergency treatment. This medication should be kept out of reach of children and should not be transferred to other containers. It is advisable to avoid driving or operating hazardous machinery while on this medication.

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

This medication must be stored in a tightly sealed container to prevent air or moisture ingress. Furthermore, it should be kept in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle