非布司他中文说明书

Chinese instruction manual:

Pharmacological effects:

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 binding of XO to 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.

Indications:

This product is a xanthine oxidase (XO) inhibitor and is suitable for the long-term treatment of hyperuricemia with gout symptoms. This product is not recommended for the treatment of asymptomatic hyperuricemia.

Specifications: 40mg/capsule or tablet; 80mg/capsule or tablet

Recommended dosage:

When used to treat patients with hyperuricemia with gout symptoms, the recommended dose of this product is 40 mg or 80 mg once a day. The recommended starting dose of this product is 40 mg, and there is no need to consider the effects of food or antacids when administering this product.

Things to note:

1. Gout attack

After starting treatment with this product, an increase in gout attacks may be observed. This is caused by changing serum uric acid levels that reduce the activity of deposited urate. To prevent gout attacks while administering this product, concomitant administration of a nonsteroidal anti-inflammatory drug or colchicine is recommended.

2. Cardiovascular diseases

In randomized controlled studies, patients taking this product [0.74 per 100 P-Y (95% CI 0.36-1.37)] were more likely to have cardiovascular thrombotic events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) than patients taking allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)]. The reasons are not yet clear. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.

3. Increased liver enzymes

In randomized controlled studies, transaminase levels were observed to be higher than 3 times the upper limit of normal (AST: 2%, 2%, ALT: 3%, 2%). No dose-response relationship was found for the increase in transaminases. Liver function laboratory analysis recommends the use of this product for treatment in February and April, and periodic treatment thereafter.