Ijatapin Tablet 200 Milligrams (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 the dose to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and tolerability. Maintenance therapy has not been evaluated in adult patients 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, 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; 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 pivotal 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 at 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 for acute treatment of bipolar disorder should continue on the same dose. The dose may be adjusted to 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 therapy. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Treatment in elderly patients should be initiated at 25 mg/day, 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. Quetiapine is primarily metabolized in the liver, so it should be administered with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, initiate treatment at 25 mg/day and gradually increase the dose by 25～50 mg per day to the effective dose.

Child dose

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 behavior in young patients with major depression or psychiatric disorders, necessitating careful assessment by a physician and close observation by patients and guardians. It can elevate blood sugar levels, so diabetic patients or those with risk factors for diabetes should regularly check blood sugar and be aware of hyperglycemia symptoms. There is a rare risk of serious Neuroleptic Malignant Syndrome during treatment; if symptoms like high fever, muscle rigidity, or changes in mental state occur, notify healthcare professionals immediately. Long-term use may result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia; consult a doctor if any abnormal signs appear. Elderly patients with dementia may have an increased risk of death when using this medication, thus requiring special caution. This medication can cause severe neutropenia or agranulocytosis; regular blood tests are necessary to check for these conditions. In patients at risk of cerebrovascular disease, caution is needed because there may be an increased risk of stroke. There is a risk of venous thromboembolism; patients with thrombotic risk factors should be carefully monitored with preventive measures. Patients with cardiovascular diseases or hypotension may experience symptoms like orthostatic hypotension upon administration, requiring careful observation and dosage adjustment. This medication can cause severe skin reactions, including Stevens-Johnson syndrome or toxic epidermal necrolysis. Discontinue use and consult a doctor immediately if symptoms like skin rash or fever occur. It should not be administered to patients with certain genetic diseases, coma, or those taking specific medications, and should be used cautiously in patients with liver impairment, cardiovascular diseases, seizure disorders, the elderly, and pregnant women. Drowsiness, dizziness, dry mouth, weight gain, and various other side effects may occur; if abnormal symptoms persist or worsen, consult a healthcare professional. Abrupt discontinuation of this medication may lead to withdrawal symptoms or worsening of symptoms, so the dosage should be gradually reduced. Pregnant or breastfeeding women should discuss potential effects on the fetus or newborn with a physician before use. This medication affects the central nervous system and can cause drowsiness or reduced alertness; caution is advised when driving or operating dangerous machinery. There may be drug interactions with this medication; inform your healthcare provider or pharmacist of any other medications being taken.

• 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 and moisture from entering, and it is recommended to keep it in a cool place below 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle