FEBUXOSTAT tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Hikma Pharmaceuticals USA Inc

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. 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 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 adve

Bidhaa muhtasari:

Febuxostat Tablets 40 mg are supplied as round, light green to green, biconvex tablet, debossed with "54 554" on one side and plain on the other side. NDC Number                Size 0054-0413-13                bottle of 30 tablets Febuxostat Tablets 80 mg are supplied as round, light green to green, biconvex tablet, debossed with "54 244" on one side and plain on the other side. NDC Number                Size 0054-0414-13                bottle of 30 tablets Protect from light. Store at 20˚ to 25°C (68˚ to 77°F). [See USP Controlled Room Temperature.]

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Hikma Pharmaceuticals USA Inc
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MEDICATION GUIDE
MEDICATION GUIDE
Febuxostat Tablets
(fe-bux’-oh-stat)
tablets, for oral use
Rx Only
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?
Febuxostat 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 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 is 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

Tabia za bidhaa

FEBUXOSTAT- FEBUXOSTAT TABLET
HIKMA PHARMACEUTICALS USA 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._
•
•
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)
_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
•
•
•
ADVERSE REACTIONS
Adverse reactions in ≥ 1% of patients treated with Febuxostat
Tablets are liver function abnormalities,
nausea, arthralgia, and rash. (6.1)
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)
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. (