1box*100 tablets

What Is Febuxostat and the 40 mg Dosage?

Febuxostat is a non-purine selective xanthine oxidase inhibitor that blocks the enzyme responsible for producing uric acid in the body. By reducing serum uric acid (sUA) levels, it addresses the root cause of gout rather than just treating symptoms.

The 40 mg tablet is the recommended starting dose for most patients. It is taken orally once daily, with or without food. After two weeks, if sUA remains above 6 mg/dL, the dose may be increased to 80 mg once daily under medical supervision. The 40 mg strength is especially suitable for patients with severe renal impairment (CrCl <30 mL/min), where higher doses are not recommended.

Febuxostat(brand name Fabulas) and generic versions contain the same active ingredient and are bioequivalent, offering the same therapeutic benefits. Generic febuxostat is typically more affordable while maintaining quality and efficacy comparable to branded options.

Indications for Febuxostat 40 mg

Febuxostat is FDA-approved for the chronic management of hyperuricemia in adult patients with gout who:

• Have an inadequate response to maximally titrated allopurinol
• Are intolerant to allopurinol
• Cannot use allopurinol for other reasons

It is not recommended for asymptomatic hyperuricemia or secondary hyperuricemia from conditions like certain cancers or Lesch-Nyhan syndrome. Clinical trials show that febuxostat 40 mg effectively reduces sUA by 30-40% in many patients, with higher response rates at 80 mg.

Gout flares may increase initially due to urate mobilization from tissue deposits—prophylaxis with colchicine or NSAIDs for up to 6 months is often advised.

Key Details from the Package Insert

The prescribing information (package insert) for febuxostat highlights essential guidance:

• Dosage and Administration — Start at 40 mg once daily; titrate to 80 mg if needed after 2 weeks based on sUA levels
• Warnings and Precautions — Includes a boxed warning for increased risk of cardiovascular death compared to allopurinol in patients with preexisting cardiovascular disease (monitor closely); risk of severe liver enzyme elevations; gout flares upon initiation
• Monitoring — Check liver function tests regularly; monitor sUA as early as 2 weeks after starting
• Drug Interactions — Contraindicated with azathioprine or mercaptopurine (increased toxicity); caution with theophylline
• Formulations — Available as 40 mg and 80 mg oral tablets (generic and brand versions like Febuxotab)

Always consult the most current package insert from the FDA or product labeling, as recommendations may update.

Benefits of Generic Febuxostat vs. Brand Name (Including Fabulas)

Generic febuxostat offers the same active ingredient, strength, dosage form, route of administration, quality, and performance as branded versions. Studies and regulatory standards confirm bioequivalence, with no significant differences in efficacy or safety. The primary advantage of generic is lower cost, making long-term gout management more accessible without compromising treatment outcomes.

Whether choosing Fabulas (brand name) or generic febuxostat, both help achieve target sUA levels below 6 mg/dL to prevent tophi, joint damage, and recurrent flares.

Why Febuxostat 40 mg Is a Key Option for Gout Management

For patients unable to tolerate or respond to allopurinol—the first-line therapy—febuxostat provides a potent alternative. Starting at 40 mg allows gradual uric acid reduction while minimizing initial flare risks. Its once-daily dosing improves adherence, and availability in generic form enhances affordability.

Discuss with your healthcare provider to determine if febuxostat 40 mg (generic or brand name Fabulas) is right for you, including monitoring for side effects and cardiovascular risks.

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Febuxostat uric acid lowering drug