United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - 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. for the safe and effective use of allopurinol, see allopurinol prescribing information. 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 expos

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - tobramycin - nebuliser solution - 300 mg/5ml - other aminoglycosides; tobramycin

United States - English - NLM (National Library of Medicine)

indoco remedies limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - 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. for the safe and effective use of allopurinol, see allopurinol prescribing information. 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

United States - English - NLM (National Library of Medicine)

msn laboratories private limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - 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

United States - English - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - 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

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - 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. for the safe and effective use of allopurinol, see allopurinol prescribing information. 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 an

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablet 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. for the safe and effective use of allopurinol, see allopurinol prescribing information. limitations of use: febuxostat tablet 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,

United States - English - NLM (National Library of Medicine)

macleods pharmaceuticals limited - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - febuxostat - film-coated tablet - 120 milligram(s) - febuxostat

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - febuxostat - film-coated tablet - 80 milligram(s) - febuxostat