feburic说明书

Instructions

Generic name: Febuxostat

Product name: uloric

Full names: febuxostat, febuxostat, feburic, febuxostat, uloric, zurig

[Character] This product is a film-coated tablet, which appears off-white after removing the coating.

【Indications】

For the treatment of chronic hyperuricemia (gout).

【Usage and Dosage】

The recommended oral dose of febuxostat tablets is 40 mg or 80 mg once daily.

The recommended starting dose of febuxostat tablets is 40 mg once daily. If the blood uric acid level is still not less than 6 mg/dl (approximately 360 µmol/L) after 2 weeks, it is recommended that the dose be increased to 80 mg once a day.

Food and antacid effects do not need to be considered when administering the drug.

Special populations: Patients with hepatic impairment: Patients with mild or moderate hepatic impairment (Child-Pugh A, B) do not need to adjust the dose. The efficacy and safety of febuxostat have not been studied in patients with severe hepatic insufficiency (Child-Pugh class C). Therefore, febuxostat should be used with caution in these patients.

Patients with renal insufficiency: Patients with mild or moderate renal insufficiency (Clcr30-89 ml/min) do not need to adjust the dose. The recommended starting dose of febuxostat is 40 mg once daily. If the blood uric acid level is still not less than 6 mg/dl after 2 weeks, it is recommended that the dose be increased to 80 mg once a day. There are insufficient study data in patients with severe renal insufficiency (Clcr<30ml/min), so febuxostat should be used with caution in these patients.

[Medicine 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.

[Medicine for children]

There have been no studies using febuxostat in pediatric patients.

【Drug use 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.

【Adverse reactions】

Common adverse reactions include headache, diarrhea, back pain, joint pain, rash, elevated transaminases, etc. There are also serious adverse reactions that may cause rash with eosinophilia and systemic symptoms.