ULORIC- febuxostat tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Cardinal Health

INN (nume internaţional):

febuxostat

Compoziție:

febuxostat 40 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

ULORIC 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 : ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)] . Risk Summary Limited available data with ULORIC 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, respectively, the exposure at the m

Rezumat produs:

ULORIC 40 mg tablets are light green to green in color, round, debossed with "TAP" on one side and "40" on the other side and supplied as: Bottle of approximately 1740 Tablets, NDC 55154-5158-8 ULORIC 80 mg tablets are light green to green in color, teardrop shaped, debossed with "TAP" on one side and "80" on the other side and supplied as: Bottle of approximately 900 Tablets, NDC 55154-5159-8 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].

Statutul autorizaţiei:

New Drug Application

Prospect

Cardinal Health
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
ULR015 R8
Revised: February 2019
MEDICATION GUIDE
ULORIC (Ū–'lor–ik)
(febuxostat)
tablets, for oral use
Read the Medication Guide that comes with ULORIC 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
ULORIC?
ULORIC 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 on one side of your
body
•
slurring of speech
•
sudden blurry vision or sudden severe
headache
What is ULORIC?
ULORIC 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.
ULORIC is not for use in people who do not have symptoms of high blood
uric acid levels.
It is not known if ULORIC is safe and effective in children.
Who should not take ULORIC?
Do not take ULORIC if you:
•
take azathioprine (Azasan, Imuran)
•
take mercaptopurine (Purinethol, Purixan)
What should I tell my doctor before taking ULORIC?
Before taking ULORIC 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 ULORIC
will harm your unborn baby.
Talk with your doctor if you are pregnant or plan to become pregnant.
•
are

Caracteristicilor produsului

ULORIC- FEBUXOSTAT TABLET
CARDINAL HEALTH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULORIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULORIC.
ULORIC (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
2/2019
Warnings and Precautions
Cardiovascular Death (5.1)
2/2019
INDICATIONS AND USAGE
ULORIC 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:
ULORIC is not recommended for the treatment of asymptomatic
hyperuricemia. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3)
CONTRAINDICATIONS
ULORIC is contraindicated in patients being treated with azathioprine
or mercaptopurine. (4)
WARNINGS AND PRECAUTIONS
•
•
GOUT PATIENTS WITH ESTABLISHED CARDIOVASCULAR (CV) DISEASE TREATED
WITH ULORIC
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 ULORIC WHEN DECIDING TO PRESCRIBE
OR CONTINUE
PATIENTS ON ULORIC. ULORIC 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 ULORIC 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 re