FEBUXOSTAT tablet, coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

FEBUXOSTAT (UNII: 101V0R1N2E) (FEBUXOSTAT - UNII:101V0R1N2E)

제공처:

Alembic Pharmaceuticals Limited

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions ( 7)] . Risk Summary   Limited available data with febuxostat tablets 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 expos

제품 요약:

Febuxostat tablets are available in two strengths as 40 mg and 80 mg.  40 mg: Light green to green, round, biconvex, film-coated tablets debossed with L440 on one side and plain on other side. They are supplied as: NDC 46708-190-30    bottle of 30 units NDC 46708-190-31    bottle of 100 units NDC 46708-190-91    bottle of 1000 units NDC 46708-190-08    80 Tablets Carton of 80 (10 x 8) Unit-Dose Tablets  NDC 46708-190-10    100 Tablets Carton of 100 (10 x 10) Unit-Dose Tablets  80 mg: Light green to green, tear drop shaped, biconvex film coated tablets debossed with L441 on one side and plain on other side and supplied as: NDC 46708-191-30    bottle of 30 units NDC 46708-191-31    bottle of 100 units NDC 46708-191-91    bottle of 1000 units NDC 46708-191-06    60 Tablets Carton of 60 (10 x 6) Unit-Dose Tablets  NDC 46708-191-10    100 Tablets Carton of 100 (10 x 10) Unit-Dose Tablets  Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

FEBUXOSTAT - FEBUXOSTAT TABLET, COATED
ALEMBIC PHARMACEUTICALS LIMITED
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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
TABLETS 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 TABLETS WHEN DECIDING TO
PRESCRIBE OR
CONTINUE PATIENTS ON FEBUXOSTAT TABLETS. FEBUXOSTAT TABLETS 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 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. (1)
(1)
For the safe and effective use of allopurinol, see allopurinol
prescribing information. (1)
Limitations of Use: (1)
Febuxostat tablets are not recommended for the treatment of
asymptomatic hyperuricemia. (1) (1)
DOSAGE AND ADMINISTRATION
Recommended febuxostat tablet 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 tablet t