FEBUXOSTAT tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Sunshine Lake Pharma Co., Ltd.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 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 a

Ürün özeti:

Febuxostat tablets 40 mg are white or almost white round film-coated tablets, debossed with “C33” on one side and blank on the other side and supplied as: Febuxostat tablets 80 mg are white or almost white capsule-shaped film-coated tablets, debossed with “C32” on one side and blank on the other side and supplied as: 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].

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Sunshine Lake Pharma Co., Ltd.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: March 2019
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
•
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 are febuxostat tablets?
Febuxostat tablet is 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 i

Ürün özellikleri

FEBUXOSTAT- FEBUXOSTAT TABLET
SUNSHINE LAKE PHARMA CO., LTD.
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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)
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 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 dail