Keratapine 100 mg Tablets (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: Take this medicine 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 the range of 150–750 mg/day according to each patient's clinical response and drug 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: Take this medicine 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, with increases of no more than 200 mg per day. Depending on each patient's clinical response and drug 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: Take this medicine 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 confirmatory clinical trial 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. Dose 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 as low as 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 individual 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 antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of 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: 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 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 an effective dose is reached.

Child dose

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

This medication may increase the risk of suicidal thoughts or actions in children, adolescents, and young adults with depression or other psychiatric disorders, so careful consideration by a doctor is necessary before use. Furthermore, blood sugar levels may rise while taking this medication, potentially worsening diabetes, so patients with diabetes or at risk for diabetes should regularly check their blood sugar. A serious side effect known as neuroleptic malignant syndrome can rarely occur; therefore, if high fever, muscle rigidity, or changes in mental state appear, immediate consultation with a physician is necessary. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms occur, dosage adjustment or discontinuation should be considered. In elderly patients with dementia, there may be an increased risk of death, so the use of this medication is not recommended. Blood abnormalities, such as neutropenia or agranulocytosis, may occur, so careful monitoring through blood tests for signs of infection is necessary. Patients at risk for cerebrovascular disease need to exercise caution when using this medication, and venous thromboembolism risk should also be assessed in advance. For patients with cardiovascular diseases or low blood pressure, orthostatic hypotension may occur, so a low initial dose should be given and gradually increased. Severe skin adverse reactions may occur, so if symptoms like rash, fever, or swollen lymph nodes appear, the medication should be discontinued immediately. This medication should not be administered to patients with certain hereditary lactose intolerance, in a comatose state, or when combined with specific central nervous system depressants. Patients with impaired liver function, older adults, those at risk of suicide, pregnant or breastfeeding women should use this medication with caution. Abrupt discontinuation of this medication may result in withdrawal symptoms, so dosage should be gradually reduced under a doctor’s instruction. Common side effects during use include drowsiness, dizziness, dry mouth, weight gain, and withdrawal symptoms, so caution in daily life is necessary. Care should be taken during driving or operating dangerous machinery, and the side effects can worsen when taken with alcohol or other central nervous system depressants. If suicidal tendencies or unusual behavioral changes occur while taking this medication, immediate consultation with healthcare professionals is necessary. Women who are pregnant or may become pregnant should take into consideration the effects on the fetus and use it with caution, and breastfeeding women are advised to avoid breastfeeding while taking this medication. In cases of overdose, severe drowsiness, low blood pressure, or heart abnormalities may occur, necessitating immediate emergency treatment. This medication should be stored out of reach of children and should not be transferred to other containers.

• 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 air or moisture from entering, and it is advisable to keep it in a cool place below 30 degrees Celsius. Storing it this way can help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow circular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle