Iquapine Tablets 25mg (Quetiapine Fumarate)

Adult dose

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 150～750 mg/day according to each patient's clinical response and drug tolerability. 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 200mg per day. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose should reach 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. In confirmatory 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. For patients who tolerate the medicine, dose reduction to as low as 200 mg has been reported in clinical trials. 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. The dose may be adjusted within a range of 300～800 mg/day, administered in 2 doses daily, according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance treatment. Elderly patients Start elderly patients on 25 mg/day of this medicine and increase gradually by 25～50 mg per day; the effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment In patients with renal or hepatic impairment, start treatment with 25 mg/day of this medicine and increase gradually 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 ideation and behavior in young individuals with major depressive disorder or psychiatric conditions; thus, physicians must carefully evaluate the necessity and risks of treatment. Patients receiving this medication may experience an increase in blood sugar levels; therefore, diabetic patients or those with risk factors should regularly monitor their blood sugar and closely observe for symptoms of hyperglycemia. There is a rare possibility of developing severe side effects known as Neuroleptic Malignant Syndrome, and if symptoms such as high fever, muscle rigidity, or changes in mental state occur, immediate medical attention is required. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia. If such abnormal symptoms occur, dosage adjustment or discontinuation should be considered. Use of this drug in elderly patients with dementia is not recommended due to an increased risk of death. Severe neutropenia or agranulocytosis may occur; therefore, white blood cell counts should be regularly monitored, and treatment should be initiated promptly upon signs of infection. Patients at risk of cerebrovascular disorders may experience an increased risk of stroke when using this medication; hence, it should be administered with caution. There is a risk of venous thromboembolism; therefore, patients with risk factors for thrombosis must be thoroughly evaluated and take preventive measures before and after treatment. Particular caution is needed in patients with cardiovascular disease or hypotension, especially during initial dose adjustments; appropriate measures should be taken if dizziness or orthostatic hypotension symptoms occur. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome may occur; thus, if symptoms like skin rash or fever appear, it is essential to stop taking the drug and consult a physician immediately. This medication should not be given to patients with hypersensitivity to certain components, patients in a coma, those taking strong central nervous system depressants, patients receiving epinephrine, diabetic patients, or patients with lactose intolerance. Patients with liver impairment may have increased blood concentration; therefore, they should start on a low dose and gradually increase while closely monitoring their condition. Pregnant or breastfeeding women should use this medication cautiously considering its effects on the fetus and newborn; it is recommended to avoid use during breastfeeding. During the use of this medication, drowsiness and dizziness may occur, so caution should be exercised when driving or operating dangerous machinery. Abrupt discontinuation of this medication may lead to withdrawal symptoms or recurrence of psychotic symptoms, thus doses should be gradually reduced. Moreover, this medication can interact with several drugs; therefore, it is crucial to inform the physician or pharmacist of any other medications taken and manage them meticulously.

• 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 protect it from air and moisture, and it is important to keep it in a cool place below 30 degrees Celsius. Be cautious as the effectiveness of the medication may decrease in warm or humid environments.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle