FEBUXOSTAT tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mylan Pharmaceuticals Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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)] . Limited available data with febuxostat tablet 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

Каталог на резюме:

Febuxostat Tablets are available containing 40 mg or 80 mg of febuxostat. The 40 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and FX1 on the other side. They are available as follows: NDC 0378-3925-93 bottles of 30 tablets NDC 0378-3925-77 bottles of 90 tablets NDC 0378-3925-05 bottles of 500 tablets The 80 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and FX2 on the other side. They are available as follows: NDC 0378-3926-93 bottles of 30 tablets NDC 0378-3926-77 bottles of 90 tablets NDC 0378-3926-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Febuxostat Tablets
(fe bux′ oh stat)
Read the Medication Guide that comes with febuxostat tablets before
you start taking them 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 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 are pregnant o

Данни за продукта

FEBUXOSTAT- FEBUXOSTAT TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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._
•
•
RECENT MAJOR CHANGES
Boxed Warning 2/2019
Indications and Usage (1) 2/2019
Warnings and Precautions
Cardiovascular Death (5.1) 2/2019
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
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3)
CONTRAINDICATIONS
Febuxostat tablets are contraindicated in patients being treated with
azathioprine or mercaptopurine. (4)
WARNINGS AND PRECAUTIONS
•
•
•
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)
Recommended febuxostat tablet dosage is 40 mg or 80 mg once daily. The
recommended starting dose is 40 mg
once daily. For patients who do