Hanwha Quetiapine Tablets 25 mg (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 tolerability. Acute treatment of manic episodes associated with bipolar I disorder — Adults: Take this medicine twice daily, with or without food. Whether used 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 200 mg 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. 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 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. In 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 300～800 mg/day, administered twice daily, according to clinical response and each patient’s tolerability. It is important to use the lowest effective dose for maintenance therapy. Elderly patients: Start treatment at 25 mg/day and gradually increase 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: Start treatment at 25 mg/day and gradually increase 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 children, adolescents, and young adults with major depressive disorder or other psychiatric conditions; therefore, the physician must carefully evaluate the risks and benefits during use. Patients receiving this medication may experience elevated blood sugar levels, so diabetic patients or those at risk for diabetes should regularly monitor their blood sugar levels. Since a serious side effect known as neuroleptic malignant syndrome can occur, patients must immediately inform healthcare providers if they experience high fever, muscle rigidity, or changes in mental state. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms occur, consultation with a physician is necessary. Use of this medication is not recommended for elderly patients with dementia due to an increased risk of death. This medication may cause severe neutropenia or agranulocytosis; hence, patients with low white blood cell counts should be cautious of infection symptoms during treatment and may need to discontinue use if necessary. Patients at risk for cerebrovascular disease may have an increased risk of stroke; caution is warranted. Due to the risk of venous thromboembolism, patients with thrombotic risk factors should be carefully monitored before and after administration. Patients with cardiovascular disease or hypotension should start treatment at a low dose and gradually increase while being attentive to blood pressure changes such as orthostatic hypotension. Severe skin adverse reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur; thus, if skin rashes or fever occur, medication should be stopped immediately, and consultation with a physician is necessary. This medication should not be administered to patients with specific genetic problems, those in a coma, those taking barbiturates, patients receiving epinephrine therapy, or diabetic patients. Patients with liver dysfunction may experience elevated blood concentrations; they should start at a low dose and be closely monitored. Pregnant or breastfeeding women should consult thoroughly with healthcare providers as this medication can affect the fetus and newborn, and breastfeeding is not recommended during its use. This medication can cause drowsiness or dizziness; caution is required when driving or operating hazardous machinery. Sudden discontinuation can lead to withdrawal symptoms or exacerbation of symptoms, so the dosage should be gradually reduced under a physician's guidance. When used with other central nervous system depressants or alcohol, interactions may enhance effects, requiring caution. Patients should regularly check weight, blood sugar, and lipid levels to manage metabolic abnormalities while on this medication. In the case of overdose, immediate medical attention is necessary, and since there is no specific antidote, intensive treatment according to symptoms is important.

• 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 closed container to protect it from air and moisture, ideally in a cool place below 30 degrees. Proper storage can help maintain the effectiveness of the medication for a longer time.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle