ULORIC febuxostat tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

febuxostat (UNII: 101V0R1N2E) (febuxostat - UNII:101V0R1N2E)

제공처:

Avera McKennan Hospital

INN (국제 이름):

febuxostat

구성:

febuxostat 40 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

New Drug Application

제품 특성 요약

ULORIC- FEBUXOSTAT TABLET
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULORIC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ULORIC.
ULORIC (FEBUXOSTAT) TABLET FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Warnings and Precautions
Hepatic Effects (5.3)
11/2012
INDICATIONS AND USAGE
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic
management of hyperuricemia in patients with gout.
(1)
ULORIC is not recommended for the treatment of asymptomatic
hyperuricemia. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3)
CONTRAINDICATIONS
ULORIC is contraindicated in patients being treated with azathioprine
or mercaptopurine. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Adverse reactions occurring in at least 1% of ULORIC-treated patients,
and at least 0.5% greater than placebo, are liver
function abnormalities, nausea, arthralgia, and rash. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TAKEDA PHARMACEUTICALS
AT 1-877-TAKEDA-7 (1-877-
825-3327) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Concomitant administration of ULORIC with XO substrate drugs,
azathioprine or mercaptopurine could increase plasma
concentrations of these drugs resulting in severe toxicity. (7)
USE IN SPECIFIC POPULATIONS
•
•
ULORIC is recommended at 40 mg or 80 mg once daily. The recommended
starting dose of ULORIC is 40 mg once
daily. For patients who do not achieve a serum uric acid (sUA) less
than 6 mg/dL after 2 weeks with 40 mg, ULORIC
80 mg is recommended. (2.1)
ULORIC can be administered without regard to food or antacid use.
(2.1)
No dose adjustment is necessary when administering ULORIC to patients
with mild to moderate renal or hepatic
impairment. (2.2)
Gout Flare: An increase in gout flares is frequently observed during
initiation of anti-hyperuricemic agents, including
ULORIC. If a gout flare occurs during treat