Quetiapine Fumarate 12.5 mg Tablets

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. Depending on the clinical response and drug tolerability of the individual patient, the dose may be adjusted within 150～750 mg/day. 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. Depending on the clinical response and drug tolerability of the individual patient, the dose may be adjusted within 200～800 mg/day; 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 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 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. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the lowest effective dose for maintenance therapy. 3. Older adults : As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when treatment is initiated. In older patients, start treatment at 25 mg/day and gradually increase by 25～50 mg per day; the effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment : In patients with renal or hepatic impairment, start treatment at 25 mg/day and gradually increase by 25～50 mg per day until the effective dose is reached.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, thus it should be used with caution. Blood sugar levels may rise during treatment; therefore, diabetes patients or those with risk factors should regularly monitor blood glucose levels and observe symptoms closely. Serious side effects may manifest as neuroleptic malignant syndrome, so immediate medical attention is needed in cases of high fever, muscle rigidity, or changes in mental status. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, necessitating consideration of dose adjustment or discontinuation if symptoms arise. There may be an increased risk of death in elderly patients with dementia; therefore, this medication is generally not recommended for such patients. Severe neutropenia or agranulocytosis could occur with a sudden drop in white blood cell count, requiring caution with infection symptoms and regular blood tests. For patients with a risk of cerebrovascular disease, there may be an increased risk of stroke, warranting special attention. Due to the risk of venous thromboembolism, patients with thrombosis risk factors should take precautions to mitigate such risks. Caution is advised for patients with cardiovascular disease or hypotension, as orthostatic hypotension may occur, necessitating careful monitoring and dose adjustments. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur, requiring immediate discontinuation if skin rash or fever symptoms manifest. This medication should not be administered to patients with specific conditions or diseases. Hepatic impairment patients, the elderly, pregnant women, and nursing mothers should use it cautiously. Common side effects such as drowsiness, dizziness, dry mouth, weight gain may occur; thus, caution is advised when driving or operating dangerous machinery. Abrupt discontinuation of this medication may result in withdrawal symptoms, so the dose should be tapered gradually. Interactions with other medications may occur; therefore, consultation with a doctor or pharmacist is recommended before concurrent use, especially with central nervous system depressants or CYP3A4 inhibitors. Pregnant or breastfeeding women should discuss with their healthcare provider whether to use this medication due to potential impacts on the fetus or newborn.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication can be sensitive to air and moisture; therefore, it should be stored in a sealed container. It is best maintained at room temperature between 1 degrees and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle