Mirae Quetiapine Tablets 200 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This drug is taken 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 the individual patient's clinical response and drug tolerability. - Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This drug is taken twice daily, with or without food. As monotherapy or as adjunctive therapy with 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. The dose may be adjusted within 200～800 mg/day according to the individual patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: This drug is taken 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 drug, 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. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, 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 during acute treatment of bipolar disorder should continue the same dose. Depending on clinical response and each patient's tolerability, the twice-daily dose may be adjusted within 300～800 mg/day. It is important to use the lowest effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotic drugs, this drug should be administered with caution to elderly patients, particularly when treatment is initiated. Start elderly patients 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. 5. Patients with renal or hepatic impairment : After oral administration of quetiapine, clearance is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, administer it with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start this drug 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 populations.

This medication may increase the risk of suicidal thoughts and behaviors in young individuals with major depressive disorder or psychiatric illnesses, therefore careful assessment by physicians and close monitoring by patients and guardians are necessary during treatment. Some patients taking this medication may experience elevated blood sugar levels leading to diabetes or hyperglycemic complications, hence patients with diabetes or at risk of hyperglycemia should regularly check their blood sugar and monitor symptoms closely. Rarely, neuroleptic malignant syndrome may manifest with symptoms of severe muscle rigidity, high fever, and altered mental status; if such symptoms occur, treatment should immediately be discontinued and medical attention sought. Prolonged use may lead to tardive dyskinesia characterized by involuntary movements of the face or around the mouth, hence any abnormal symptoms should be discussed with a physician. Caution is particularly warranted when administering this medication to elderly patients with dementia, as there is an increased risk of death. Severe neutropenia or agranulocytosis resulting in a sharp decrease in blood cell counts may occur; hence, white blood cell counts should be monitored regularly through blood tests during the initial phase of treatment. Patients at risk of cerebrovascular disease may have an increased risk of stroke while on this medication; hence careful observation and management are recommended. As there is a risk of thrombosis, patients with risk factors for thrombosis should be monitored closely before and after taking this medication. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension while taking this medication, hence caution is advised. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) may occur rarely; if symptoms such as skin rash or fever develop, treatment should be stopped immediately. This medication should not be used in patients with certain allergies, comatose states, those on certain central nervous system depressants, those receiving epinephrine, diabetic patients, and patients with lactose intolerance. In patients with impaired liver function or the elderly, treatment should start at a lower dose and should be gradually increased while monitoring the patient's condition closely. Common side effects may include drowsiness, dizziness, and dry mouth, so caution is needed when driving or operating hazardous machinery. Pregnant or breastfeeding women should consult their physician before taking this medication, as it may affect the fetus or neonate. Overdose can result in severe drowsiness, hypotension, and tachycardia, necessitating immediate medical treatment. When taken with other central nervous system depressants or alcohol, the effects may be enhanced, so caution is advised. Regular monitoring of blood sugar, weight, blood pressure, and blood tests during medication use is important to detect and manage any abnormal symptoms early.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglycerides
• 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, preferably in a cool place below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance

White, round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle