PMS Quetiapine Tablet 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: Take this medicine 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 the range of 150～750 mg/day according to the clinical response and tolerability of each patient. - Maintenance therapy has not been evaluated in adult patients 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: Take this medicine twice daily, with or without food. 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 the range of 200～800 mg/day according to the clinical response and tolerability of each patient; 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, with or without food. 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 were administered as follows: 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. 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 medicine, clinical trials indicate that the dose may be reduced to as low as 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 for acute treatment of bipolar disorder should continue on the same dose. The dose may be adjusted within the range of 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. 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: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

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

This drug is used to treat psychiatric disorders and careful observation is needed for young patients with suicidal tendencies. It is not approved for use in children and adolescents, and caution should be exercised as it may increase the risk of suicide. It may affect blood sugar control, so diabetic patients or those with risk factors for diabetes should regularly monitor their blood sugar levels. In severe cases, ketoacidosis or coma may occur due to hyperglycemia, so symptoms should be closely monitored. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, characterized by high fever, muscle rigidity, and changes in mental status; if these symptoms occur, immediate medical attention is required. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms arise, dose adjustment or discontinuation should be considered. It is not recommended for elderly patients with dementia due to an increased risk of mortality. Severe neutropenia or agranulocytosis can occur, so regular white blood cell counts should be performed, and treatment should be administered promptly if infection symptoms appear. Patients with cardiovascular diseases or hypotension may experience symptoms like orthostatic hypotension, so the initial dose should be started low and monitored carefully. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely; if skin rashes or fever occur, take immediate action to discontinue use. This drug should not be administered to patients with certain genetic lactose intolerance or to patients in a comatose state or those receiving epinephrine. Patients with liver dysfunction may have increased plasma concentrations, so treatment should start at a low dose and be monitored closely. Pregnant or breastfeeding women may affect the fetus or newborn, so it should only be used cautiously when necessary, and breastfeeding during treatment is preferably avoided. Common side effects include drowsiness, dizziness, dry mouth, and weight gain, requiring caution when driving or operating machinery. There is no specific antidote for overdose; immediate medical measures and intensive monitoring are necessary. During treatment, avoid concomitant use with other central nervous system depressants or alcohol and consult with a physician regarding potential drug interactions. Sudden discontinuation of the drug may cause withdrawal symptoms, so it is safer to taper the dose gradually.

• 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 prevent exposure to air or moisture, and it is important to maintain a temperature below 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle