Mirae Quetiapine Tablets 300 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 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 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

Children and adolescents: The safety and efficacy of this drug have not been established.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. Therefore, doctors must carefully assess the necessity and risks when prescribing to patients in this age group. All patients of all ages taking this drug should be closely monitored for signs of suicidal tendencies, worsening of the condition, aggression, and other abnormal behavioral changes. Family members or caregivers should also provide careful attention to the patient. This drug can cause an increase in blood sugar in some patients, leading to diabetes or severe complications related to hyperglycemia, so patients with diabetes or risk factors for hyperglycemia should regularly monitor and manage their blood sugar levels. Rare but life-threatening symptoms called neuroleptic malignant syndrome may occur, so if symptoms such as high fever, muscle rigidity, or changes in mental status appear, immediate medical attention should be sought. Long-term use carries a risk of extrapyramidal symptoms and tardive dyskinesia, so if these symptoms occur, consult a physician about dosage adjustment or discontinuation. In elderly patients with dementia, this medication may increase the risk of death, thus it is not recommended for use in patients with dementia-related psychosis. Serious hematological abnormalities, such as neutropenia or agranulocytosis, can rarely occur, so patients with low white blood cell counts should regularly have their blood counts checked and seek immediate treatment if symptoms of infection arise. Patients with a risk of cerebrovascular disease may have an increased risk of stroke, thus special care should be taken when prescribing to these patients. Venous thromboembolism may occur, so patients with risk factors for thrombosis should check risk factors before and during treatment with this drug. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension during initial dose adjustments; thus, dosage should be adjusted if symptoms of dizziness or fainting occur. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur, so if symptoms like skin rashes, fever, or lymphadenopathy arise, discontinue use and seek medical attention immediately. This drug should not be administered to patients with hypersensitivity, those in a coma, patients taking strong central nervous system depressants, patients who have been administered epinephrine, patients with diabetes, or those with lactose intolerance. Caution is advised when administering this drug to patients with impaired liver function, cardiovascular disease, those with a history of seizures, the elderly, patients at risk of suicide, and pregnant or nursing mothers. The patient's condition should be closely monitored before and after administration. Common side effects of this drug include drowsiness, dizziness, dry mouth, and weight gain; therefore, it is advisable to avoid driving or operating hazardous machinery during treatment. There are no specific antidotes for overdose, so symptomatic support and intensive management are required. Taking this drug during pregnancy may cause withdrawal symptoms or extrapyramidal symptoms in newborns, so careful consideration of the risks and benefits for the fetus and newborn is necessary. Nursing mothers are advised to avoid breastfeeding while taking this drug. Combining this drug with other central nervous system depressants or alcohol may enhance its effects, so caution is necessary when co-administered. In addition, drug concentrations may change when used with drugs that inhibit or induce specific liver enzymes, so dosage adjustments may be needed according to a physician's instructions. It is important to conduct regular blood tests and clinical condition assessments to detect adverse reactions early and respond appropriately during the course of treatment.

• 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 protect it from air and moisture, at a cool place below 30 degrees Celsius. Proper storage can help maintain the drug's efficacy longer.

Appearance

White oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle