FEBUXOSTAT tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Aphena Pharma Solutions - Tennessee, LLC

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Febuxostat Tablets are 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 p

Огляд продуктів:

Febuxostat Tablets 40 mg are supplied as round, light green to green, biconvex tablet, debossed with "54 554" on one side and plain on the other side. NDC Number Size 51407-293-30 bottle of 30 Febuxostat Tablets 80 mg are supplied as round, light green to green, biconvex tablet, debossed with "54 244" on one side and plain on the other side. NDC Number Size 51407-294-30 bottle of 30

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Febuxostat Tablets
(fe-bux’-oh-stat)
tablets, for oral use
Rx Only
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?
Febuxostat 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
• shortness of breath or trouble breathing
• dizziness, fainting or feeling lightheaded
• rapid or irregular heartbeat
• numbness or weakness in one side of your body
• slurring of speech
• sudden blurry vision or sudden severe headache
What is 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 is 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 do

Характеристики продукта

FEBUXOSTAT- FEBUXOSTAT TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FEBUXOSTAT TABLETS
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 02/2019
Indications and Usage 02/2019
Warnings and Precautions
Cardiovascular Death ( 5.1) 02/2019
INDICATIONS AND USAGE
Febuxostat Tablets are 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 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 da