INDICATIONS AND USAGE

Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

DOSAGE

Recommended Dose

The recommended febuxostat tablet dosage is 40 mg or 80 mg once daily.

The recommended starting dosage of febuxostat tablet is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended febuxostat tablet dosage is 80 mg once daily.

Febuxostat tablets can be taken without regard to food or antacid use.

ADVERSE REACTIONS

Heart problems

Gout Flares

Liver problems

Severe skin and allergic reactions

abnormal liver function tests

joint pain

nausea

rash

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/9a87099f-d82d-42c7-872a-b87d3917e960/spl-doc?hl=febuxostat

Zuriginformation