Keratapine 25 mg (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 is used to treat psychiatric disorders and requires special caution in individuals with suicidal tendencies or young patients with depression. During treatment, abnormal behavioral changes such as suicidal thoughts or actions, and aggression should be closely monitored, and family members or guardians should also monitor the patient carefully. There is a risk of increased blood sugar, so diabetics or those with a family history of diabetes should regularly check blood sugar levels and closely monitor symptoms. Neuroleptic malignant syndrome, characterized by severe muscle stiffness, high fever, and altered mental status, may rarely occur, so immediate medical attention is required if such symptoms appear. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so dosage adjustment or discontinuation should be considered if abnormal symptoms arise. The use of this medication in elderly patients with dementia is not recommended, as it may increase the risk of death, thus requiring extreme caution. Blood abnormalities such as neutropenia and agranulocytosis may occur, so regular monitoring of white blood cell counts and immediate treatment for any signs of infection is necessary. Special care is needed when using this medication in patients at risk of cerebrovascular disease, and the risk of thrombosis should be assessed and preventive measures taken. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension during initial dosing, so dosage adjustments should be made slowly while monitoring. Severe skin reactions may occur, so if symptoms like rash, desquamation, or fever appear, immediately discontinue use and consult a physician. This medication should not be administered to specific patients, such as those allergic to it, in a comatose state, taking central nervous system depressants, or diabetic patients. Caution should be exercised when administering this drug to patients with compromised liver function, a history of cardiovascular or cerebrovascular diseases, the elderly, and pregnant women, and their condition should be continuously monitored. Common side effects include drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, speech disturbances, restless legs syndrome, syncope, nightmares, sleepwalking, constipation, dyspepsia, vomiting, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, blurred vision, muscle pain, priapism, galactorrhea, and increased appetite; if these symptoms are severe, consult a physician. This medication affects the central nervous system and may cause drowsiness or decreased attention, so caution is necessary when driving or operating dangerous machinery. Pregnant women should consult a physician before taking this medication, as it may lead to withdrawal symptoms or movement disorders in newborns. Sudden discontinuation may lead to withdrawal symptoms, so the dosage should be reduced gradually when stopping. There may be interactions with other drugs, so if taking other medications, be sure to inform a doctor or pharmacist.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglycerides
• 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 exposure and kept at a cool temperature below 30 degrees Celsius. Storing it this way can maintain its effectiveness for a longer period.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle