FEBUXOSTAT- febuxostat tablets 40 mg film FEBUXOSTAT- febuxostat tablets 80 mg film

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Macleods Pharmaceuticals Limited

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Febuxostat 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. Limitations of Use: Febuxostat is 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 development

Rezumat produs:

Febuxostat 40 mg tablets are green, biconvex, round, film- coated tablets debossed with "M 87" on one side and plain on the other side and supplied as: NDC Number            Size 33342-274-07  bottles of 30 Tablets 33342-274-10  bottles of 90 Tablets 33342-274-15  bottles of 500 Tablets Febuxostat 80 mg tablets are green, biconvex, teardrop-shaped, film-coated tablets debossed with "M 88" on one side and plain on the other side and supplied as: NDC Number            Size 33342-275-07  bottles of 30 Tablets 33342-275-10  bottles of 90 Tablets 33342-275-15  bottles of 500 Tablets Protect from light. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FEBUXOSTAT - FEBUXOSTAT TABLETS 40 MG FILM
MACLEODS PHARMACEUTICALS LIMITED
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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 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)
Limitations of Use: (1)
Febuxostat tablet is 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 is contraindicated in pat