Ketapine Tablet 25 mg (Quetiapine Fumarate)

Adult dose

1. 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 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 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 200mg per day. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 200～800 mg/day, and 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 above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, 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 in the 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 the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. Elderly patients should start treatment with 25 mg/day of this medicine, with gradual increases of 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment Clearance after oral administration 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. Patients with renal or hepatic impairment should start treatment with 25 mg/day of this medicine, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

Efficacy and safety in children and adolescents have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in young patients with major depressive disorder or psychiatric conditions, so the risk of suicide must be carefully monitored before and during treatment. While using this medication, blood sugar may rise, leading to the development of diabetes or complications related to high blood sugar; therefore, diabetic patients or those at risk for high blood sugar should regularly monitor blood glucose levels and symptoms. Rarely, it may cause a serious side effect known as neuroleptic malignant syndrome; symptoms such as high fever, muscle rigidity, or altered consciousness should prompt immediate notification to medical personnel. Long-term use may lead to tardive dyskinesia, an involuntary movement disorder; if abnormal movements occur, consult a physician. In elderly patients with dementia, this medication may increase the risk of death and should either not be used or be administered with caution. Blood disorders such as agranulocytosis and neutropenia may occur, hence immediate notification to medical personnel is necessary if symptoms of infection or fever arise, and regular blood tests should be conducted. There may be an increased risk of stroke in patients with a risk of cerebrovascular disease, necessitating caution during administration. There is a risk of venous thromboembolism, so patients with thrombotic risk factors should take preventive measures and seek immediate treatment for any unusual symptoms. Patients with cardiovascular diseases or hypotension may experience side effects such as orthostatic hypotension; dosage adjustments may be necessary if symptoms occur. Severe skin reactions may occur; if symptoms such as rash, peeling, or fever arise, discontinue the drug immediately and visit a hospital. This medication should not be used in patients with certain allergies, those in a coma, patients taking specific medications, or diabetic patients. Patients with liver impairment, cardiovascular diseases, cerebrovascular diseases, a history of seizures, elderly patients, pregnant women, and breastfeeding mothers should use this medication with caution. Common side effects such as drowsiness, dizziness, dry mouth, weight gain, and changes in blood lipids and glucose levels should be closely monitored. This medication affects the central nervous system, potentially causing drowsiness or decreased attention; caution is advised when driving or operating hazardous machinery. There may be drug interactions, so consult a physician or pharmacist before taking other medications, especially those that can cause severe blood pressure drops should not be taken concurrently. Women who are pregnant or breastfeeding should carefully consider the use of this medication, as withdrawal symptoms may present in newborns. Abruptly discontinuing this medication can lead to withdrawal symptoms, so reducing the dosage gradually is safer. In cases of overdose, symptoms such as severe drowsiness, hypotension, or cardiac abnormalities may occur, requiring immediate emergency treatment. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. When administered to the elderly, initiate at a low dose and closely monitor their condition, gradually increasing the dosage.

• 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 or moisture and should ideally be kept in a cool place below 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer duration.

Appearance

Orange round film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle