Febuxostat

Generic Name: febuxostat

Xanthine Oxidase Inhibitor [EPC]Over-the-Counter (OTC)

Brand Names:

Febuxostat

Febuxostat is a xanthine oxidase inhibitor available in 40 mg and 80 mg tablet strengths for oral use in the management of hyperuricemia.

Overview

Febuxostat is a xanthine oxidase inhibitor available in 40 mg and 80 mg tablet strengths for oral use in the management of hyperuricemia.

Uses

Indicated for chronic management of hyperuricemia in adult gout patients with inadequate response to maximally titrated allopurinol, intolerance to allopurinol, or when allopurinol is not advisable.

Dosage

Recommended starting dose is 40 mg once daily. For patients not achieving serum uric acid less than 6 mg/dL after 2 weeks, increase to 80 mg daily. Severe renal impairment limited to 40 mg daily. Can be taken without regard to food or antacids.

Side Effects

Most common: liver function abnormalities, nausea, arthralgia, and rash. Serious reactions include cardiovascular death, hepatic failure, and Stevens-Johnson Syndrome.

Interactions

Contraindicated with xanthine oxidase substrates azathioprine and mercaptopurine. Use caution with theophylline. No significant interactions with colchicine, NSAIDs, warfarin.

Warnings

Higher rate of cardiovascular death in patients with established cardiovascular disease compared to allopurinol treatment. Cases of fatal hepatic failure reported. Serious skin reactions including SJS and TEN occurred postmarketing. Contraindicated in patients being treated with azathioprine or mercaptopurine.

Pregnancy

Limited human data insufficient for developmental risk assessment. Animal studies showed no teratogenic effects. Insufficient data on presence in human milk.

Storage

Protect from light. Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F).

Frequently Asked Questions

What is Febuxostat used for?

Indicated for chronic management of hyperuricemia in adult gout patients with inadequate response to maximally titrated allopurinol, intolerance to allopurinol, or when allopurinol is not advisable.

What are the side effects of Febuxostat?

Most common: liver function abnormalities, nausea, arthralgia, and rash. Serious reactions include cardiovascular death, hepatic failure, and Stevens-Johnson Syndrome.

Can I take Febuxostat during pregnancy?

Limited human data insufficient for developmental risk assessment. Animal studies showed no teratogenic effects. Insufficient data on presence in human milk.

What are the important warnings for Febuxostat?

Higher rate of cardiovascular death in patients with established cardiovascular disease compared to allopurinol treatment. Cases of fatal hepatic failure reported. Serious skin reactions including SJS and TEN occurred postmarketing. Contraindicated in patients being treated with azathioprine or mercaptopurine.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.