Myungmoon Quetiapine Tablets 200 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia - Adults: This medication 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, the dose should be adjusted 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 drug tolerability. Acute treatment of manic episodes associated with bipolar I disorder - Adults: This medication is taken twice daily, regardless of meals. 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 drug tolerability; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder - Adults: This medication 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 pivotal clinical trials of this medication, 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. In patients who tolerate the medication, reduction to as low as 200 mg has been shown to be possible in clinical trials. 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 on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300～800 mg/day, given twice daily. It is important to use the minimum effective dose for maintenance therapy. Older adults: Older patients should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day; the effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment: Patients with renal or hepatic impairment should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

The safety and efficacy of this drug have not been established in children and adolescents.

This drug is primarily used to treat psychiatric disorders. During treatment, there may be an increase in suicidal thoughts or behaviors, particularly in children, adolescents, and young adults, so careful judgment and monitoring by a physician are essential. Additionally, this drug can raise blood sugar levels, so patients with diabetes or risk factors for diabetes should regularly check their blood sugar levels. If symptoms of hyperglycemia such as thirst, frequent urination, and fatigue occur, consult a doctor immediately. Rarely, this drug may cause a serious side effect known as neuroleptic malignant syndrome, characterized by high fever, muscle stiffness, and changes in mental state, which requires immediate medical attention. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, thus if any abnormal symptoms arise, consider adjusting the dose or discontinuation. In elderly patients with dementia, the risk of death may increase, therefore the use of this drug is not recommended. This drug can reduce the white blood cell count in the blood, increasing the risk of infections, so symptoms of infections should be observed carefully during treatment. Patients with a history of cardiovascular disease or cerebrovascular disease or those at risk of hypotension should exercise caution during initial dosing, as orthostatic hypotension may occur. Severe skin reactions such as Stevens-Johnson syndrome may occur, so if symptoms such as skin rash or fever appear, discontinue use immediately and consult a doctor. This drug should not be administered to specific patients, such as those with allergies to this drug or its components, those in a comatose state, those taking certain medications, and patients with diabetes. Patients with liver dysfunction, elderly patients, those with cardiovascular diseases, or a history of epilepsy should be administered this drug carefully, and pregnant or breastfeeding women should consult a doctor prior to use. Common side effects during treatment include drowsiness, dizziness, dry mouth, so caution should be taken when driving or operating hazardous machinery. Abruptly stopping this drug may lead to withdrawal symptoms or the recurrence of psychiatric symptoms, so dosage should be gradually reduced. Also, since there may be interactions with other medications, be sure to inform your doctor or pharmacist of any medications you are currently taking. In case of overdose, visit a medical institution immediately for appropriate treatment, as there is no specific antidote and intensive treatment may be necessary based on symptoms. Keep out of the reach of children and do not transfer to another container for safety.

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

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture and kept in a cool place below 30 degrees Celsius. This helps maintain the drug's efficacy for a longer time.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle