FEBUXOSTAT tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Novadoz Pharmaceuticals LLC

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 adve

Prehľad produktov:

Febuxostat 40 mg tablets are green colored, round shaped, biconvex, film coated tablets, debossed with "40" on one side and "F" on other side and supplied as: Bottles of 30 tablets……….………....….... (NDC 72205-028-30) Bottles of 90 tablets……………………..... (NDC 72205-028-90) Bottles of 500 tablets……..……………..... (NDC 72205-028-05) Febuxostat 80 mg tablets yellow colored, capsule shaped, biconvex, film coated tablets, debossed with "80" on one side and plain on other side and supplied as:    Bottles of 30 tablets……………………...... (NDC 72205-029-30) Bottles of 100 tablets…………………….... (NDC 72205-029-91) Bottles of 1000 tablets…………………...... (NDC 72205-029-99) 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].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

FEBUXOSTAT - FEBUXOSTAT TABLET, FILM COATED
NOVADOZ PHARMACEUTICALS LLC
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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
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 patients being treated with
azathioprine or merca