Iquafin 100mg Tablets (Quetiapine Fumarate)

Adult dose

Adults with schizophrenia: 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. Maintenance treatment has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. Acute treatment of manic episodes associated with bipolar I disorder in 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 in 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 in 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: As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. 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: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is mainly metabolized in the liver, administer with caution to patients with known 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 thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses; therefore, the prescribing physician should carefully assess the patient's condition and instruct the patient and caregivers to closely monitor symptoms. This drug can elevate blood sugar levels; thus, patients with diabetes or those at risk for diabetes should regularly monitor blood glucose and pay attention to symptoms of hyperglycemia. Neuroleptic Malignant Syndrome is a rare but serious side effect that may occur, so if symptoms such as high fever, muscle rigidity, or changes in mental status arise, immediate consultation with a healthcare professional is necessary. Prolonged use may lead to extrapyramidal symptoms and tardive dyskinesia; if abnormal symptoms appear, consideration should be given to dose adjustment or discontinuation. In elderly patients with dementia, the use of this medication may increase the risk of death; therefore, it should be avoided or used with extreme caution. Severe neutropenia and agranulocytosis may occur with a rapid decrease in white blood cell count; accordingly, blood tests should monitor white cell status during the initial administration. In patients at high risk for cerebrovascular event, there may be an increased risk for stroke; hence, caution is advised. There is a risk of venous thromboembolism; patients with thrombotic risk factors should take preventive measures and observe symptoms. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension when taking this medication, so they should watch for symptoms and gradually adjust the dose. Severe skin adverse reactions may occur, hence if symptoms such as skin rash, fever, or lymph node swelling appear, discontinue the medication immediately and notify healthcare providers. This medication should not be administered to patients with specific diseases or conditions, and caution is needed in patients with liver dysfunction, cardiovascular diseases, a history of seizure disorders, the elderly, pregnant women, and nursing mothers. Common side effects include drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglycerides, elevated total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, fainting, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, etc.; therefore, potential impacts on daily life should be cautiously observed. This medication acts on the central nervous system, inducing drowsiness and decreased concentration; therefore, caution is necessary when driving or operating hazardous machinery. Sudden discontinuation during use can trigger withdrawal symptoms, so dose reduction should be done gradually. There may be interactions with other drugs, particularly central nervous system depressants, liver enzyme inducers, and potent CYP3A4 inhibitors; hence, caution is warranted when coadministering. When administered to pregnant women, there may be effects on the fetus; thus, women who are pregnant or may become pregnant should consult a physician before use, and nursing mothers are advised to avoid breastfeeding while taking this medication. In the event of an overdose, immediate medical intervention is required, and there is no specific antidote for this medication, making supportive care according to symptoms vital. This medication should be kept 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 exposure to air or moisture, and it is recommended to store it in a cool place below 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle