Febuxostat Extended Release Tablets 80mg Suppliers & Bulk Manufacturers

Available Forms: tablets

Available Strengths: 80mg

Reference Brands: Adenuric (EU/UK)

Category: Nephrology

Febuxostat is an oral xanthine-oxidase inhibitor indicated for long-term management of hyperuricaemia in patients with gout who require urate-lowering therapy. It is prescribed when allopurinol is unsuitable or not tolerated.

Product Description:

Febuxostat is a non-purine selective inhibitor of xanthine oxidase, the enzyme that converts hypoxanthine and xanthine into uric acid. Unlike allopurinol it is not a purine analogue, and it is cleared mainly by the liver rather than the kidneys, so it can often be used at standard doses in moderate renal impairment, where allopurinol dosing becomes complicated.

It is used for long-term management of high uric acid in gout, not for an acute attack; starting it can in fact precipitate a flare as crystals mobilise, which is why colchicine or an NSAID is given as cover for the first months. The important safety point emerged after approval: a large cardiovascular safety trial found higher cardiovascular and all-cause mortality with febuxostat than with allopurinol, leading the FDA to add a boxed warning and restrict it to patients who have failed or cannot tolerate allopurinol, and European regulators to advise caution in established cardiovascular disease. Liver enzymes are monitored.

Sourcing notes. Off patent, with generics widely available. The extended-release 80 mg tablet is an Indian-market formulation and a separate registration from immediate-release tablets, needing its own bioequivalence data. Labelling must carry the local cardiovascular warning.