FEBUXOSTAT tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Aphena Pharma Solutions - Tennessee, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 is 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 exposures up to 40 a

Povzetek izdelek:

Febuxostat tablets 40 mg tablets are light green to green coloured, round, biconvex, film coated tablet debossed with "18" on one side and "I" on the other side and supplied as: NDC Number          Size 27808-206-01          Bottle of 30 Tablets Febuxostat tablets 80 mg tablets are light green to green coloured, tear drop shaped, biconvex, film coated tablet debossed with "19" on one side and "I" on the other side and supplied as: NDC Number          Size 27808-207-01         Bottle of 30 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].

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Aphena Pharma Solutions - Tennessee, LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: May 2020
MEDICATION GUIDE
Febuxostat tablets
(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
•
shortness or 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 are Febuxostat Tablets?
Febuxostat tablets are 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 tablet 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 beco

Lastnosti izdelka

FEBUXOSTAT- FEBUXOSTAT TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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)
For the safe and effective use of allopurinol, see allopurinol
prescribing information.
Limitations of Use:
Febuxostat tablets is 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