Dongwha Quetiapine Tablets 300 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medicine is taken twice daily, regardless of meals. 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 tolerability. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder Adults: This medicine is taken twice daily, regardless of meals. As monotherapy or 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 tolerability, and the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder Adults: This medicine is taken once daily at bedtime, regardless of meals. 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 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 at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trials have shown 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 for acute treatment of bipolar disorder should continue on the same dose. The dose administered twice daily may be adjusted within 300～800 mg/day according to clinical response and individual tolerability. It is important to use the lowest effective dose for maintenance therapy. Older adults: As with other antipsychotics, this medicine should be administered with caution to older adults, particularly at the start of treatment. Start treatment at 25 mg/day and gradually increase by 25～50 mg daily. The effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment: Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Start treatment with this medicine at 25 mg/day and gradually increase by 25～50 mg daily until an effective dose is reached.

Child dose

Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents.

This medication can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so physicians must carefully evaluate the necessity and risks of treatment. Patients of all ages receiving this medication should be closely monitored for changes in behavior, including suicidal tendencies, worsening of the illness, and aggression. Family members or caregivers should also closely observe the patient and be able to contact a physician. This medication may increase the risk of hyperglycemia or diabetes, so patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar levels and be vigilant about hyperglycemia symptoms. Severe side effects known as neuroleptic malignant syndrome can occur; if symptoms such as high fever, muscle rigidity, or changes in mental state occur, immediate medical attention should be sought. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, and if these symptoms occur, adjustments in dosage or discontinuation of the medication should be considered. Elderly patients with dementia may have an increased risk of death, so the use of this medication is not advised in this population. Severe blood dyscrasias such as agranulocytosis or neutropenia can occur, so white blood cell counts should be regularly monitored and immediate treatment sought if infection symptoms appear. There may be an increased risk of cerebrovascular events, so patients with risk factors for stroke should be particularly cautious. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be carefully monitored and take preventive measures before and during treatment. Patients with cardiovascular diseases, cerebrovascular diseases, or hypotension should be administered this medication with caution, particularly during initial dose adjustments, as orthostatic hypotension may occur. There is a risk of severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, so if symptoms such as rash, fever, or lymphadenopathy appear, the medication should be stopped immediately, and medical attention sought. This medication should not be administered to specific patient populations, such as those with hypersensitivity to this drug or any of its components, patients in a comatose state, those with significant interactions with central nervous system depressants, patients receiving epinephrine, diabetic patients, and lactose-intolerant patients. Patients with liver impairment may experience slower metabolism of this medication, leading to higher blood concentrations, so they should start with lower doses and be carefully monitored. Pregnant or breastfeeding women should use this medication cautiously due to risks to the fetus and newborn, and breastfeeding women are advised to avoid breastfeeding while on this medication. This medication can cause drowsiness, dizziness, and decreased attention, requiring caution while driving or operating hazardous machinery. Sudden discontinuation of the medication can lead to withdrawal symptoms; therefore, dosages should be tapered down gradually if discontinuation is necessary. This medication can interact with various drugs, so it is essential to consult with a physician or pharmacist if taking other medications.

• 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 closed container to protect it from air and moisture, maintaining a storage temperature below 30 degrees Celsius. This helps preserve the medication's effectiveness and prevent degradation.

Appearance

White oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle