非布司他说明书

Instructions

Drug name: Febuxostat tablets

Generic name: Febuxostat

Mechanism of action:

Febuxostat is rapidly and extensively absorbed by >80% after oral administration, with a tmax of approximately 1.0 to 1.8 hours. Febuxostat does not accumulate in the body after multiple oral administrations of a single daily dose. The effect of multiple doses of Febuxostat 80 mg on reducing serum uric acid concentration is not affected by food, so the clinical use of Febuxostat does not require consideration of food factors. The steady-state apparent volume of distribution (Vss/F) of febuxostat after oral administration of 10 mg to 300 mg is 29 to 75 L. Febuxostat is approximately 99.2% plasma protein bound (mainly to albumin). Four hours after oral administration of febuxostat, unchanged drug in plasma accounted for 84%-96% of the total radioactivity. The plasma half-life of febuxostat is 5 to 8 hours. Taking the drug once a day will reach steady-state plasma concentration within 1 week. Febuxostat is mainly eliminated from the blood by being metabolized by the liver to glucuronide conjugates, and a smaller amount is oxidatively metabolized by CYP450 in the liver. Glucuronide-conjugated febuxostat is excreted in the urine, and less than 4% of febuxostat is excreted unchanged in the urine after oral administration.

Indications: It is suitable for the long-term treatment of hyperuricemia in patients with gout. It is not recommended for asymptomatic hyperuricemia.

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.

Adverse reactions:

1. Liver function damage (unknown frequency), because the increase in AST (GOT) and ALT (GPT) is accompanied by liver function damage, patients should have regular examinations and discontinue medication if they are found to be unwell.

2. Allergy (unknown frequency), systemic rash, skin rash, etc. Patients should be checked regularly and discontinue medication if any discomfort is found.

Special groups:

No dose adjustment is required in patients with mild or moderate renal impairment. The recommended starting dose of this product is 40 mg once daily. After a dose of 40 mg for two weeks, for patients whose serum uric acid level (sUA) is still higher than 6 mg/dl, the recommended dose is 80 mg.

No dose adjustment is required for patients with mild to moderate hepatic impairment. There are no studies on the use of this product in patients with severe hepatic impairment, so this product should be administered with caution.

For uric acid level, serum uric acid can be re-tested after 2 weeks of treatment with this product. The goal of treatment is to reduce and maintain serum uric acid levels below 6 mg/dl. It is recommended to take the medicine for at least 6 months to prevent acute attacks of gout.

Taboo:

1. Patients with past allergies to the ingredients; 2. Patients taking sulfhydryl-containing drugs or azathioprine tablets at the same time.