Febuxostat is the generic equivalent of the brand-name drug Febuxostat. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Febuxostat through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 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. Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat is a 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 treatmen…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [see Warnings and Precautions (5.1)] Hepatic Effects [see Warnings and Precautions (5.3)] Serious Skin Reactions [see Warnings and Precautions (5.4)] Adverse reactions in 1% of patients treated with febuxostat are liver function abnormalities, nausea, arthralgia, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.…
Drug Interactions
7 DRUG INTERACTIONS Concomitant administration of febuxostat with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity. (7) 7.1 Xanthine Oxidase Substrate Drugs Febuxostat is an XO inhibitor. Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans [see Clinical Pharmacology (12.3)]. Therefore, use with caution when coadministering febuxosta…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. (2.1) • Patients with severe renal impairment: Limit the dosage to 40 mg once daily. (2.2, 8.6) • Flare prophylaxis is recommended upon initiation of febuxostat tablets. (2.4) • Can be administered without regard to food or antacid use…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). CV Death Inform patients that gout patients with established CV disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. Inform all patients of the higher rate of CV death with febuxostat tablets compared to allopurinol. Alert all patients (those with and without CV disease) for the development of signs and symptoms of CV events and to seek medical care promptly should they occur [see Warnings and Prec…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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