feburic中文说明书

Chinese instruction manual

Generic name: Febuxostat

Product name: uloric

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

Indications:

For the treatment of chronic hyperuricemia (gout).

The starting dose of feburic (febuxostat) 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. Patients with mild or moderate hepatic insufficiency (Child-Pugh classes A and B) do not need to adjust the dosage. Patients with severe hepatic insufficiency (Child-Pugh class C) should use febuxostat with caution.

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.

Medication for children:

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.

Drug overdose:

The dose of this product was administered to healthy subjects up to 300 mg per day for 7 days without dose-limiting toxicity. No cases of overdose have been reported. Patients with overdose should receive symptomatic and supportive care.

Things to note:

1. Gout attack: In the early stage of taking febuxostat, it may cause gout attack. This is caused by the change in uric acid level and the mobilization of urate deposited in the tissue. At this time, there is no need to stop taking the medicine. Taking nonsteroidal anti-inflammatory drugs or colchicine at the same time during the initial use of febuxostat can prevent gout attacks.

2. Cardiovascular events: So far, the causal relationship between this drug and cardiovascular thrombotic events has not been determined, but the febuxostat 80mg group had more cardiovascular events, so symptoms and signs of myocardial infarction and cardiovascular death should be monitored when taking the drug.

3. Secondary hyperuricemia: This drug has not been studied in patients with secondary hyperuricemia, so its use is not recommended for patients with secondary hyperuricemia.

4. Effects on the liver: Patients who use febuxostat will experience abnormal liver function, such as fatigue, loss of appetite, jaundice, diarrhea, headache, etc. During clinical medication, when abnormal liver function is found in patients, the medication should be discontinued and the possible cause should be determined as much as possible. When the cause is unclear, it is not suitable to use (febuxostat) in these patients.