非布索坦详细的说明书

Detailed instructions

[Generic drug name] Febuxostat (Febuxostat)

[English name of drug] feburic

[Ingredients] The main ingredient of febuxostat is febuxostat.

[Character] Febuxostat is a film-coated tablet, which appears white or off-white after the coating is removed.

[Indications] Febuxostat is a xanthine oxidase (XO) inhibitor and is suitable for the long-term treatment of hyperuricemia with gout symptoms.

[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.

[Adverse reactions] Weakness, chest pain/discomfort, edema, fatigue, abnormal mood, gait disorder, influenza symptoms, gas, pain, and thirst.

[Contraindications] Febuxostat is contraindicated in patients taking azathioprine, mercaptopurine, or choline.

【Notes】

1. After starting treatment with febuxostat, 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 when febuxostat is administered, concomitant administration of an NSAID or colchicine is recommended.

2. In randomized controlled studies, patients taking febuxostat were more likely to have cardiovascular thrombotic events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) than patients taking allopurinol. The reasons are not yet clear. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.

3. In randomized controlled studies, it was observed that transaminase levels were higher than 3 times the upper limit of normal (increased in patients receiving and allopurinol, respectively, AST: 2%, 2%, ALT: 3%, 2%). No dose-response relationship was found for the increase in transaminases. Liver function laboratory analysis recommends treatment with febuxostat for 2 and 4 months, followed by periodic treatment thereafter.