FEBUXOSTAT tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sun Pharmaceutical Industries, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 tablets are 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, respectively, the exposure at the maximum recommended human dose (MRHD). No advers

Produkt oppsummering:

Febuxostat 40 mg tablets are round, biconvex, green colored, film-coated tablets with ‘721’ debossed on one side and plain on other side and supplied as: NDC Number Size 47335-721-83                                     Bottle of 30 Tablets with Child Resistant Cap 47335-721-81                                     Bottle of 90 Tablets with Child Resistant Cap 47335-721-13                                     Bottle of 500 Tablets with Non Child Resistant Cap Febuxostat 80 mg tablets are oval, biconvex, green colored, film-coated tablets with ‘722’ debossed on one side and plain on other side and supplied as: NDC Number Size 47335-722-83                                     Bottle of 30 Tablets with Child Resistant Cap 47335-722-88                                     Bottle of 100 Tablets with Child Resistant Cap 47335-722-18                                     Bottle of 1000 Tablets with Non Child Resistant Cap Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Febuxostat (fe-BUX-oh-stat) tablets, for oral use
Read the Medication Guide that comes with febuxostat tablets before
you start taking it and each time you get a
refill. There may be new information. The Medication Guide does not
take the place of talking with your doctor
about your medical condition or your treatment.
What is the most important information that I should know about
febuxostat tablets?
Febuxostat tablets may cause serious side effects, including:
Heart-related deaths.
Call your doctor or get emergency medical help right away if you have
any of the following symptoms,
especially if they are new, worse, or worry you:
•
chest pain
•
numbness or weakness on one side of your body
•
shortness of breath or trouble breathing
•
slurring of speech
•
dizziness, fainting or feeling lightheaded
•
sudden blurry vision or sudden severe headache
•
rapid or irregular heartbeat
What are febuxostat tablets?
Febuxostat tablets are a prescription medicine called a xanthine
oxidase (XO) inhibitor used to lower blood uric
acid levels in adult patients with gout when allopurinol has not
worked well enough or when allopurinol is not
right for you. Febuxostat tablets are not for use in people who do not
have symptoms of high blood uric acid
levels.
It is not known if febuxostat tablets are safe and effective in
children.
Who should not take febuxostat tablets?
Do not take febuxostat tablets if you:
•
take azathioprine (Azasan*, Imuran*)
•
take mercaptopurine (Purinethol*, Purixan*)
What should I tell my doctor before taking febuxostat tablets?
Before taking febuxostat tablets tell your doctor about all of your
medical conditions, including if you:
•
have taken allopurinol and what happened to you while you were taking
it.
•
have a history of heart disease or stroke.
•
have liver or kidney problems.
•
are pregnant or plan to become pregnant. It is not known if febuxostat
tablets will harm your unborn baby.
Talk with your doctor if you

Preparatomtale

FEBUXOSTAT- FEBUXOSTAT TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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)
INDICATIONS AND USAGE
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 treatment with allopurinol
is not advisable. (1) (1)
Limitations of Use: (1)
Febuxostat tablets are not recommended for the treatment of
asymptomatic hyperuricemia. (1) (1)
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. (2.1)
(2)
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3) (3)
CONTRAINDICATIONS
Febuxos