zurig中文说明书

(Febuxostat) Chinese instructions

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.

Usage and dosage:

The recommended oral starting dose is 40 mg, once a day. If the blood uric acid level is still not less than 6 mg/dL (360 μg) after two weeks, it is recommended to increase the dose to 80 mg, once a day. The maximum dosage is 120 mg/day. This dose is effective for patients with higher blood uric acid levels.

Drug interactions:

Febuxostat's inhibitory effect on xanthine oxidase may increase the blood concentration of drugs metabolized by this enzyme, such as azathioprine, mercaptopurine, and theophylline, resulting in toxicity. Therefore, this drug is prohibited from being used in patients who are taking these three drugs.

Things to note:

Due to the rapid decrease in serum uric acid concentration in the early stage of taking this product, the 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.

Contraindications: This product is contraindicated in patients taking azathioprine, mercaptopurine or chophylline.

Medication for pregnant and lactating women:

There are no sufficient controlled studies in pregnant women, and in animal experiments it was found that febuxostat can be excreted through breast milk, but it has not been determined whether it will be excreted through human milk. Therefore, pregnant and lactating women should use this drug with caution.

Pediatric Use: There have been no studies using febuxostat in pediatric patients.

Medication for Elderly Patients: Clinical studies have shown that after multiple oral administrations of febuxostat to elderly subjects, Cmax and AUC24 are similar to those of young subjects, so there is no need to adjust the dose in the elderly.

Overdose: Febuxostat was administered to healthy subjects at doses up to 300 mg daily for 7 days without dose-limiting toxicity. No cases of overdose have been reported. Patients with overdose should receive symptomatic and supportive care.