PMS Quetiapine Tablets 300 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

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

This medication should be used cautiously in children, adolescents, and young adults with major depression or psychiatric disorders as it may increase the risk of suicidal thoughts and behaviors. During the use of this medication, blood sugar levels may rise, so patients with diabetes or those at risk for diabetes should check their blood sugar levels regularly. Rarely, serious Neuroleptic Malignant Syndrome (NMS), characterized by high fever, muscle rigidity, and changes in mental state, may occur; if these symptoms appear, inform healthcare providers immediately. Long-term use may lead to tardive dyskinesia, which is a movement disorder with abnormal involuntary movements; consult a physician if symptoms appear. It is advisable not to use this medication in elderly patients with dementia as it may increase the risk of death. Severe neutropenia or agranulocytosis may occur, necessitating regular blood tests for monitoring for those early in treatment. Patients at risk for cerebrovascular disease may experience increased risk of stroke while on this medication, thus caution is necessary. Venous thromboembolism risks necessitate careful monitoring of patients with thromboembolism risk factors before and during administration. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension while taking this medication; symptoms should be reported immediately if they occur. This medication may cause severe skin reactions; if symptoms such as rash, fever, or lymphadenopathy appear, discontinue use and consult a physician. This medication should not be administered to patients with hypersensitivity to it, patients in a comatose state, patients taking strong central nervous system depressants, patients undergoing epinephrine administration, diabetic patients, and patients with lactose intolerance. Careful administration with dose adjustments and monitoring is necessary in patients with impaired liver function, cardiovascular diseases, seizures history, elderly patients, individuals at risk for suicide, and pregnant or nursing women. Common side effects include drowsiness, dizziness, dry mouth, weight gain, changes in blood sugar and lipid levels, thus caution is advised. Be cautious when driving or operating machinery, and use extra care when combining with alcohol or other central nervous system depressants. Women who are pregnant or may become pregnant should make careful decisions about the risks to the fetus when using this medication, and it is recommended that nursing mothers avoid breastfeeding while on this medication. Abrupt discontinuation of this medication may lead to withdrawal symptoms, so doses should be gradually reduced; any side effects or unusual symptoms should be reported to healthcare providers immediately.

• 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 sealed container to prevent exposure to air and moisture, and it is best to keep it in a cool place below 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness over time.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle