Aikuaipin Tablet 200 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medicine is 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, adjust 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. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medicine is taken twice daily, with or without food. As monotherapy or as adjunctive therapy with 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 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. (2) Treatment of depression associated with bipolar disorder: - Adults: This medicine is taken 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 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 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. The dose may be adjusted within 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. 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 initiating treatment. Start elderly patients on 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 : Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. Start patients with renal or hepatic impairment on 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions; thus, a doctor's careful assessment is required before administration. Blood sugar levels may rise during treatment, and individuals with diabetes or risk factors for diabetes should have their blood sugar monitored regularly and observe symptoms closely. Rarely, a serious side effect known as Neuroleptic Malignant Syndrome may occur, so if symptoms like hyperthermia, muscle rigidity, or changes in mental status arise, immediate notification of medical personnel is required. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so dosage adjustment or discontinuation should be considered if these symptoms manifest. Elderly patients with dementia may experience an increased risk of mortality when using this medication, requiring special caution. Severe neutropenia or agranulocytosis may occur, necessitating regular blood tests to monitor white blood cell counts and immediate treatment if infection symptoms are present. Patients with cerebrovascular or cardiovascular disorders should be cautious as this medication may increase the risk of stroke and other complications. There is a risk of venous thromboembolism; thus, patients with thromboembolic risk factors must be assessed before administration and preventive measures taken. Patients with impaired liver function, elderly individuals, pregnant or breastfeeding women, and those at risk of suicide should be treated with increased caution, requiring dosage adjustments and monitoring of conditions. Common side effects may include drowsiness, dizziness, dry mouth, weight gain, and changes in blood lipids and glucose levels, so these symptoms should be monitored closely during treatment. Abrupt discontinuation can lead to withdrawal symptoms or worsening of psychiatric symptoms, so dosages should be gradually reduced following a doctor's guidance. Caution is necessary when taking this medication concurrently with other central nervous system depressants or alcohol, as side effects may be amplified. Women who are pregnant or may become pregnant must consider the effects on the fetus before use, and breastfeeding women are advised to avoid breastfeeding during treatment. Attention is required while driving or operating hazardous machinery, and immediate emergency care is needed in the event of a drug overdose. This medication is not recommended for children and adolescents due to the lack of established safety and efficacy.

• 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 protect it from air and moisture, preferably in a cool place below 30 degrees Celsius. This is to maintain the drug's efficacy and prevent deterioration.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle