Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E)
Ascend Laboratories, LLC
ORAL
PRESCRIPTION DRUG
Febuxostat tablet 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 treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablet is not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)]. Risk Summary Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times,
Febuxostat 40 mg tablets are light green to green in colour, round shaped coated tablets, debossed with "F40" on one side and plain on the other side and supplied as: NDC Number Size 67877-668-30 Bottle of 30 Tablets 67877-668-90 Bottle of 90 Tablets 67877-668-10 Bottle of 1000 Tablets 67877-668-38 Hospital Unit Dose Pack of 100 Tablets Febuxostat 80 mg tablets are light green to green in colour, tear drop shaped coated tablets, debossed with "F80" on one side and plain on the other side and supplied as: NDC Number Size 67877-669-30 Bottle of 30 Tablets 67877-669-01 Bottle of 100 Tablets 67877-669-10 Bottle of 1000 Tablets 67877-669-38 Hospital Unit Dose Pack of 100 Tablets Protect from light. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
FEBUXOSTAT - FEBUXOSTAT TABLET, FILM COATED ASCEND LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FEBUXOSTAT TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FEBUXOSTAT TABLETS. FEBUXOSTAT TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: CARDIOVASCULAR DEATH SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. GOUT PATIENTS WITH ESTABLISHED CARDIOVASCULAR (CV) DISEASE TREATED WITH FEBUXOSTAT HAD A HIGHER RATE OF CV DEATH COMPARED TO THOSE TREATED WITH ALLOPURINOL IN A CV OUTCOMES STUDY. (5.1) CONSIDER THE RISKS AND BENEFITS OF FEBUXOSTAT WHEN DECIDING TO PRESCRIBE OR CONTINUE PATIENTS ON FEBUXOSTAT. FEBUXOSTAT SHOULD ONLY BE USED IN PATIENTS 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. (1) RECENT MAJOR CHANGES Boxed Warning 2/2019 Indications and Usage 2/2019 Warnings and Precautions Cardiovascular Death (5.1) 2/2019 INDICATIONS AND USAGE Febuxostat tablet 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 treatment with allopurinol is not advisable. (1) For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use: Febuxostat tablet are not recommended for the treatment of asymptomatic hyperuricemia. (1) (1) DOSAGE AND ADMINISTRATION Recommended febuxostat tablets dosage is 40 mg or 80 mg once daily. The recommended starting dose 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) Can be administered without regard to food or antacid use. (2.1) Limit the dosage of febuxostat tablets to 40 mg once daily in patients with severe rena Les hele dokumentet