FEBUXOSTAT tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Viona Pharmaceuticals Inc

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)] . Risk Summary Limited available data with febuxostat 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). No adverse developm

Огляд продуктів:

Febuxostat Tablets, 40 mg are white to off-white, beveled-edge, oval-shaped tablets debossed with "401" on one side and plain on the other side and are supplied as follows: NDC 72578-136-06 in bottle of 30 tablets with child-resistant closure. NDC 72578-136-16 in bottle of 90 tablets with child-resistant closure. NDC 72578-136-01 in bottle of 100 tablets NDC 72578-136-05 in bottle of 500 tablets NDC 72578-136-10 in bottle of 1,000 tablets NDC 72578-136-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Febuxostat Tablets, 80 mg are white to off-white, beveled-edge, round-shaped tablets debossed with "402" on one side and plain on the other side and are supplied as follows: NDC 72578-137-06 in bottle of 30 tablets with child-resistant closure. NDC 72578-137-16 in bottle of 90 tablets with child-resistant closure. NDC 72578-137-01 in bottle of 100 tablets NDC 72578-137-05 in bottle of 500 tablets NDC 72578-137-10 in bottle of 1,000 tablets NDC 72578-137-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Viona Pharmaceuticals Inc
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SPL MEDGUIDE
MEDICATION GUIDE
Febuxostat (fe buxʹ 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
•
numbness or weakness on one side of
your body
•
shortness of breath or trouble breathing
•
slurring of speech
•
dizziness, fainting or feeling lightheaded
•
sudden blurry vision or sudden severe
headache
•
rapid or irregular heartbeat
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
tablets will harm
your unborn baby. Talk with your do

Характеристики продукта

FEBUXOSTAT- FEBUXOSTAT TABLET
VIONA 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.
GOUT PATIENTS WITH ESTABLISHED CARDIOVASCULAR (CV) DISEASE TREATED
WITH FEBUXOSTAT
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 WHEN DECIDING TO
PRESCRIBE OR
CONTINUE PATIENTS ON FEBUXOSTAT. FEBUXOSTAT 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. (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 is contraindicated in patients being treated with
azathioprine or mercaptopurine. (4)
WARNINGS AND