Samsung Quetiapine 100 mg Tablets (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: Take this medicine 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 5 onward, adjust the dose to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: Take this medicine twice daily, regardless of meals. Whether used 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, in increments of no more than 200 mg per day. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: Take this medicine 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 confirmatory clinical trials 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For patients who tolerate the medicine, 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 on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the lowest effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting treatment. Elderly patients should start with 25 mg/day, with gradual increases of 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 : Patients with renal or hepatic impairment should start with 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

This drug is primarily used to treat psychiatric disorders, and several precautions must be strictly followed when taking it. First, this drug may increase suicidal tendencies, so especially young patients aged 18 to 24 should have their behavioral changes closely monitored by doctors and family members during the initial treatment or when adjusting the dose. Second, there is a risk of increased blood sugar, so diabetic patients or those with risk factors for diabetes should regularly monitor blood sugar and carefully observe symptoms of hyperglycemia such as thirst, frequent urination, and fatigue. Third, serious side effects known as Neuroleptic Malignant Syndrome can occur rarely; therefore, if high fever, muscle rigidity, or changes in mental state occur, medical personnel should be notified immediately. Fourth, prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia, so if there are abnormal movements or discomfort, consultation with a doctor is necessary. Fifth, elderly patients with dementia may have an increased risk of death, necessitating extreme caution in the use of this drug. Sixth, serious blood abnormalities such as neutropenia or agranulocytosis may occur, so white blood cell counts should be monitored regularly and immediate treatment is required if any signs of infection appear. Seventh, patients with heart conditions or cerebrovascular diseases should be cautious as there may be increased risks of orthostatic hypotension or cerebrovascular diseases. Eighth, this drug may increase the risk of thromboembolism, so patients with risk factors for thrombosis should be carefully monitored before and after taking this medication. Ninth, patients with impaired liver function may have increased drug concentration in the blood, so starting with a lower dose and gradually increasing it is advised. Tenth, women who are pregnant or breastfeeding should be cautious with the use of this drug as side effects may occur in the fetus or newborn; consultation with a doctor is recommended before use. Finally, this drug may cause drowsiness or dizziness, so caution is required when driving or operating dangerous machinery. When taking this drug, it is important to adhere to the precise dosage and administration methods as directed by a doctor, and to consult with medical personnel immediately if there are any unusual symptoms.

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

This drug should be stored in a well-sealed container to protect it from air or moisture and kept in a cool place below 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over time.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle