FEBUXOSTAT tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Tris Pharma Inc

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. 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 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 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD). N

Ürün özeti:

Febuxostat 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 80 mg tablets are light green to green coloured, teardrop 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].

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Tris Pharma Inc
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MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
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
on 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 is not known if febuxostat
tablet

Ürün özellikleri

FEBUXOSTAT- FEBUXOSTAT TABLET
TRIS PHARMA INC
----------
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)
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)
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of
asymptomatic hyperuricemia. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage is 40 mg or 80 mg once daily. The recommended
starting dosage 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)
Patients with severe renal impairment: Limit the dosage to 40 mg once
daily. (2.2, 8.6)
Flare prophylaxis is recommended upon initiation of febuxostat
tablets. (2.4)
Can be administered without regard to food or antacid use. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3)
CONTRAINDICATIONS
Febuxostat tablets are contraindicated in patients being treated with
azathio