非布索坦（非布司他）说明书

(Febuxostat) Instructions

【Drug name】Febuxostat

[Drug Mechanism] Febuxostat can treat gout by tightly binding to the active site of the molybdopterin center of xanthine oxidase (XO), keeping the redox-state molybdenum cofactor in an isolated state, thereby inhibiting the combination of XO and the substrate, reducing the formation of uric acid, and lowering the level of uric acid in the blood. Therefore, febuxostat has a significant inhibitory effect on oxidized and reduced XO.

[Properties] White tablets.

[Specification] 40mg/tablet; 80mg/tablet.

[Indications] It is used for the treatment of chronic hyperuricemia (gout).

[Usage and Dosage] The starting dose of febuxostat can be 40 mg/day and 80 mg/day, of which the 80 mg dose is more effective for severe patients. If the serum uric acid level is still higher than 6 mg/dL after taking 40 mg/day for 2 weeks, you can take 80 mg/day.

【Adverse reactions】

1. Abnormal liver function, nausea, joint pain, rash, diarrhea and dizziness, among which abnormal liver function is a serious adverse reaction.

2. Common adverse reactions include upper respiratory tract infection, muscle and skeletal muscle and related tissue abnormalities, headache, edema, pulmonary infection, paresthesia and hypoesthesia, etc.

3. Serious adverse reactions are cardiovascular diseases, including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. The incidence rate is higher than that of allopurinol. The incidence rate of cardiovascular adverse reactions is not related to the dose of febuxostat and does not increase with the extension of treatment time.

[Contraindications] This product is contraindicated in patients taking azathioprine, mercaptopurine, chophylline, etc.

[Precautions] Due to the rapid decrease in serum uric acid concentration in the early stage of taking the drug, uric acid deposited in the tissue can be mobilized, so symptoms similar to gout attacks may occur. In this case, nonsteroidal anti-inflammatory drugs or colchicine can be used for preventive administration. In addition, during the treatment of this product, some patients need to be monitored for symptoms related to myocardial infarction and liver damage.

[Drug use in elderly patients] Clinical trials have shown that the response of elderly patients to this product is similar to that of young people, and no dose adjustment is required.

[Drugs for Pregnant and Lactating Women] Febuxostat can be secreted into the milk of rats, but it is not clear whether it is secreted into human milk. Therefore, it should be used with caution during pregnancy and lactation.