Ijatabine 25 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medicine is taken twice daily, regardless of meals. 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 usual effective daily dose should be adjusted to 300～400 mg. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and tolerability. Maintenance treatment has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medicine is taken twice daily, regardless of meals. 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. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and tolerability, 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, regardless of meals. 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 at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, the dose may be reduced to a minimum of 200 mg based on 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. The dose may be adjusted within the range of 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance treatment. 3. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Treatment in older patients should be initiated at 25 mg/day, with gradual increases of 25～50 mg daily; the effective dose in older adults may be lower than 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. In patients with renal or hepatic impairment, initiate treatment with this medicine at 25 mg/day and gradually increase the dose by 25～50 mg daily until an effective dose is reached.

Child dose

The safety and efficacy in children and adolescents have not been established.

This medication is primarily used for the treatment of psychiatric disorders, particularly for depression, schizophrenia, and bipolar disorder. When taking this medication, there may be an increased risk of suicide, therefore, especially young patients aged 18 to 24 should be closely monitored for suicidal thoughts or abnormal behavior changes after starting treatment. It can affect blood sugar control, so diabetic patients or those at risk for diabetes should regularly monitor their blood sugar and closely observe for hyperglycemia symptoms such as thirst or frequent urination. This medication can rarely cause serious side effects known as Neuroleptic Malignant Syndrome. Therefore, if symptoms such as high fever, muscle rigidity, or changes in mental status occur, immediate notification to healthcare providers is required. With long-term use, extrapyramidal symptoms or tardive dyskinesia can occur, so if abnormal movements or muscle stiffness appear, consultation with a physician is necessary. Elderly patients with dementia may have an increased risk of death when using this medication, so special caution is needed. Severe neutropenia or agranulocytosis leading to a rapid decrease in white blood cell count may occur, so if there are signs of infection or fever, immediate consultation with healthcare providers is necessary. Patients at risk of cerebrovascular disorders may have an increased risk of stroke when administered this medication, so caution is advised. There is a risk of venous thromboembolism; thus, patients with risk factors for thrombosis should be closely monitored before and during treatment. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension when taking this medication, so dosage should be adjusted gradually, and their condition should be closely monitored. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may occur, so if symptoms like a rash or fever appear, the medication should be suspended immediately, and healthcare providers must be notified. Patients with specific genetic metabolic issues, those in a coma, or those receiving certain medications (e.g., epinephrine) should not use this medication together. Patients with poor liver function, the elderly, those at risk of suicide, pregnant or breastfeeding women should use this medication with caution and follow healthcare provider instructions. Common side effects may include drowsiness, dizziness, dry mouth, weight gain, etc.; thus, caution is advised when driving or operating dangerous machinery. In cases of overdose, severe toxicity symptoms may occur; if this happens, immediate medical attention is required.

• 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 sealed container to prevent exposure to air or moisture and kept in a cool place with a temperature below 30 degrees Celsius.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle