FEBUXOSTAT tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

DR REDDY'S LABORATORIES LIMITED

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 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

Vörulýsing:

Febuxostat tablets, 40 mg are light yellow to yellow, round shaped film coated tablets imprinted with‘ 40’ (logo with ‘40’) on one side and plain on other side and are supplied in bottles of 30's, 90’s, 100’s, and 500’s. Bottles of 30                                       NDC 55111-796-30 Bottles of 90                                       NDC 55111-796-90 Bottles of 100                                     NDC 55111-796-01 Bottles of 500                                     NDC 55111-796-05 Febuxostat tablets, 80 mg are light yellow to yellow, oval shaped film coated tablets imprinted with‘ 80’ (logo with ‘80’) on one side and plain on other side and are supplied in bottles of 30's, 90’s, 100’s, and 500’s. Bottles of 30                                       NDC 55111-797-30 Bottles of 90                                       NDC 55111-797-90 Bottles of 100                                     NDC 55111-797-01 Bottles of 500                                     NDC 55111-797-05 Protect from light. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

FEBUXOSTAT- FEBUXOSTAT TABLET
DR REDDY'S LABORATORIES LIMITED
----------
MEDICATION GUIDE
Febuxostat (feb-UX-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. This 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 in 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 tablet is a prescription medicine called a xanthine oxidase
(XO) inhibitor used to lower blood
uric acid levels in adults 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 is 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.
•
have a history of heart disease or stroke.
•
are pregnant or plan to become pregnant. It is not known if febuxostat
tab

Vara einkenni

FEBUXOSTAT- FEBUXOSTAT TABLET
DR REDDY'S LABORATORIES LIMITED
----------
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 tablets are not recommended for the treatment of
asymptomatic hyperuricemia. (1)
DOSAGE AND ADMINISTRATION
Recommended febuxostat 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 to 40 mg once daily in patients
with severe renal impair