Mirae Quetiapine Tablets 100 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 in children and adolescents have not been established.

This medicine is mainly used for the treatment of psychiatric disorders, particularly prescribed for depression, schizophrenia, and bipolar disorder. When taking this medication, there may be an increased risk of suicidal thoughts or behaviors, so close monitoring by a physician is necessary, especially in young patients aged 18 to 24. Blood sugar levels may rise or diabetes may worsen, so patients with diabetes or those with blood sugar regulation issues should regularly check their blood sugar levels. Rarely, neuroleptic malignant syndrome, characterized by severe muscle rigidity, high fever, and changes in mental status, may occur, and if these symptoms appear, immediate medical consultation is required. Long-term use may cause extrapyramidal symptoms or tardive dyskinesia, so if there are abnormal movements, consult a physician. Elderly patients with dementia may have an increased risk of death with this medication, so caution is needed. The number of neutrophils in the blood may decrease significantly, so if symptoms of infection or fever develop, immediate treatment is necessary, and periodic blood tests should be conducted. Patients with cerebrovascular or cardiovascular diseases may have an increased risk of stroke while taking this medication, so caution is advised. This medication can cause orthostatic hypotension, leading to dizziness or fainting, particularly when first taking the medicine or adjusting the dosage. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, so if symptoms like rash or fever appear, the medication should be stopped immediately, and a healthcare professional should be informed. This drug should not be administered to patients with certain genetic metabolic disorders and may be dangerous in comatose patients or when combined with certain central nervous system depressants. Pregnant or nursing women must consult with a physician before taking this medication, as withdrawal symptoms may appear in newborns. During treatment, symptoms such as drowsiness, dizziness, and dry mouth may occur, so caution is necessary when driving or operating machinery. Abrupt discontinuation of this medication can lead to withdrawal symptoms; therefore, tapering should be done gradually under physician guidance when stopping. There may be interactions with other medications, so if taking other drugs, be sure to inform your healthcare provider, especially when combined with strong liver enzyme inhibitors or central nervous system depressants. In the case of overdose, severe drowsiness, sedation, and low blood pressure may occur, and since there is no specific antidote, immediate intensive care at a medical facility is required. Keep out of reach of children and take care not to change containers arbitrarily.

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

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is also recommended to keep it at a cool temperature below 30 degrees Celsius.

Appearance

Yellow, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle