FEBUXOSTAT tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Febuxostat tablets are available in two strengths as 40 mg and 80 mg.  40 mg: Light green to green, round, biconvex, film-coated tablets debossed with L440 on one side and plain on other side. They are supplied as: NDC 62332-190-30    bottle of 30 units NDC 62332-190-31    bottle of 100 units NDC 62332-190-91    bottle of 1000 units NDC 62332-190-08    80 Tablets Carton of 80 (10 x 8) Unit-Dose Tablets  NDC 62332-190-10    100 Tablets Carton of 100 (10 x 10) Unit-Dose Tablets  80 mg: Light green to green, tear drop shaped, biconvex film coated tablets debossed with L441 on one side and plain on other side and supplied as: NDC 62332-191-30    bottle of 30 units NDC 62332-191-31    bottle of 100 units NDC 62332-191-91    bottle of 1000 units NDC 62332-191-06    60 Tablets Carton of 60 (10 x 6) Unit-Dose Tablets  NDC 62332-191-10    100 Tablets Carton of 100 (10 x 10) Unit-Dose 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Alembic Pharmaceuticals Inc.
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Medication Guide
Febuxostat (feb-UX-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 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 pregnan

Summary of Product characteristics

FEBUXOSTAT - FEBUXOSTAT TABLET, COATED
ALEMBIC 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
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)
(1)
Limitations of Use: (1)
Febuxostat tablets are not recommended for the treatment of
asymptomatic hyperuricemia. (1) (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
tablet. (2.4)
• Can be administered without regard to food or antacid use. (2.1)
(2)
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3) (3)
CONTRAINDICATIONS
Febuxostat tablets a