Thiafen Tablet 200 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia, adults: Take 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 adults with schizophrenia. Patients should be reevaluated regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder, adults: Take 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 tolerability; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder, adults: Take 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 the confirmatory 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trials indicate that the dose may be reduced to as low as 200 mg in patients who tolerate the medicine. 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 be maintained on the same dose. The dose may be adjusted within a range of 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: As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Start 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: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. As quetiapine is metabolized primarily in the liver, administer with caution to patients with known hepatic impairment. Start this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

The safety and efficacy of this medication have not been established in pediatric and adolescent patients.

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, so a doctor's careful assessment is required before administration. There is a risk of elevated blood sugar, so patients with diabetes or those requiring blood sugar regulation should regularly check their blood sugar levels and meticulously observe for symptoms of hyperglycemia such as increased thirst or frequent urination. A rare but serious side effect called neuroleptic malignant syndrome may occur, so if symptoms such as high fever, muscle rigidity, or changes in mental status appear, medical personnel should be informed immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if unusual movements occur, consult a doctor. Elderly patients with dementia may be at increased risk of mortality when using this medication, so special caution is needed. Rare blood-related adverse reactions such as severe neutropenia or agranulocytosis may occur, necessitating immediate consultation with a doctor if symptoms of infection or fever arise. Patients at risk for cerebrovascular disease may have an increased risk of stroke while taking this medication and should use it carefully. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be assessed and preventive measures taken before administration. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension, particularly during initial dosing and dose increases, so caution is especially needed. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction may occur, so if symptoms such as skin rash or fever arise, immediate discontinuation of the drug and medical consultation are required. This medication should not be administered to patients with allergies to specific ingredients, those in a comatose state, patients requiring caution when using central nervous system depressants, those receiving epinephrine, patients with diabetes, and those with lactose intolerance. Patients with impaired liver function, cardiovascular disease, a history of epilepsy, elderly patients, pregnant and lactating women should use this medication carefully, ensuring appropriate dose adjustments and monitoring. This medication may cause various side effects such as drowsiness, dizziness, dry mouth, and weight gain, so caution is needed when driving or operating hazardous machinery. There may be interactions with other medications during treatment, so it is essential to inform the doctor or pharmacist of any current medications being taken. Pregnant or breastfeeding women should consult with medical professionals before administration, as this medication may affect the fetus or newborn. Safety and efficacy have not been established for pediatric and adolescent patients, thus use is not recommended. In overdose cases, severe drowsiness, hypotension, and heart problems may occur, so strict adherence to the prescribed dosage is essential, and immediate hospital visit is necessary in case of overdose. When storing, keep this medication out of the reach of children, and do not transfer it 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 avoid exposure to air or moisture, and it is important to keep the temperature below 30 degrees Celsius. Therefore, avoid direct sunlight or high-temperature environments and store in a cool place.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle