Quetiapine Tablets 200 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medicine should be taken 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. 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: This medicine should be taken 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. Depending on each patient's clinical response and tolerability, 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: This medicine should be taken once daily at bedtime, with or without food. The total daily dose should reach 300 mg by Day 4, with 50 mg on Day 1, 100 mg on Day 2, and 200 mg on Day 3. In the 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. For 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. 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 minimum effective dose for maintenance therapy. 3. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start with 25 mg/day and the dose should be gradually increased by 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment After oral administration of quetiapine, clearance 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. Patients with renal or hepatic impairment should start with 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 medication have not been established in children and adolescents.

This medication is primarily used to treat psychiatric disorders, especially prescribed for depression, mania, and schizophrenia. During the course of this medication, the risk of suicidal thoughts or behaviors may increase in some young patients, hence both patients and guardians should carefully monitor for signs. Patients with diabetes or issues with blood glucose control should regularly check their blood sugar levels, and if symptoms of hyperglycemia appear, they should consult with healthcare professionals immediately. This medication may rarely cause a serious neurological side effect known as Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle rigidity, and changes in mental status occur, it is critical to stop taking the medication immediately and seek medical attention. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia; therefore, if abnormal movements are observed, dose adjustment or discontinuation should be considered. Elderly patients with dementia may have an increased risk of mortality and thus require special caution. Leukopenia can occur, so it's important to notify healthcare providers immediately if any infection symptoms or fever occur. Patients at risk for cerebrovascular disorders should exercise extra caution when using this medication, and the risk of venous thromboembolism should be assessed, with preventive measures taken. Patients with cardiovascular diseases or hypotension should be mindful of orthostatic hypotension and exercise caution during initial dose adjustments. This medication can cause severe skin reactions; therefore, if symptoms such as skin rash, fever, or lymph node swelling occur, it should be discontinued immediately. This medication is contraindicated in patients who are allergic to this drug or any of its components, in a coma, or who are using specific central nervous system depressants, are undergoing epinephrine treatment, have diabetes, or have lactose intolerance. For patients with impaired liver function, the elderly, or those with cardiovascular diseases, the medication should be started at a low dose while observing the condition, with gradual increases as necessary. Common side effects include drowsiness, dizziness, dry mouth, weight gain, and lipid abnormalities in the blood, which may affect daily activities. Caution should be exercised when driving or operating heavy machinery, and it is recommended to avoid concurrent use with alcohol or other central nervous system depressants. Women who are pregnant or nursing should consult their doctor before use, as this medication may affect the fetus or newborn. In cases of overdose, severe hypotension, sedation, and drowsiness may occur; there is no specific antidote available, thus immediate medical attention is required. This medication is not recommended for use in children and adolescents as its safety and efficacy have not been established in this population. Regular blood tests and physical status checks are necessary during treatment, and if any abnormal symptoms develop, immediate consultation with healthcare professionals is required.

• Suicidal impulses
• suicidal tendencies
• hyperglycemia
• diabetic ketoacidosis
• diabetic coma
• abnormal high fever
• changes in mental state
• muscle stiffness
• autonomic nervous system anxiety
• increased creatine phosphokinase

This medication should be kept in a tightly closed container to protect it from air and moisture, and stored in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle