뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - febuxostat hemihydrate 120mg - film coated tablet - 120 mg - active: febuxostat hemihydrate 120mg excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 85f42129 purified water - treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). dp-febuxostat is indicated in adults. for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (tls).

미국 - 영어 - NLM (National Library of Medicine)

rebel distributors corp - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat 80 mg - uloric® is a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. uloric is not recommended for the treatment of asymptomatic hyperuricemia. uloric is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline [see drug interactions (7)] . pregnancy category c : there are no adequate and well-controlled studies in pregnant women. uloric should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. febuxostat was not teratogenic in rats and rabbits at oral doses up to 48 mg per kg (40 and 51 times the human plasma exposure at 80 mg per day for equal body surface area, respectively) during organogenesis. however, increased neonatal mortality and a reduction in the neonatal body weight gain were observed when pregnant rats were treated with oral doses up to 48 mg per kg (40 times the human plasma exposure at 80 mg per day) during organogenesis and through lactation period. febuxos

미국 - 영어 - 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

미국 - 영어 - 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

미국 - 영어 - 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

미국 - 영어 - 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,

요르단 - 영어 - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة المتحدة لصناعة الأدوية - united pharmaceutical manufacturing co. ltd. - febuxostat 120 mg - 120 mg

미국 - 영어 - 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

미국 - 영어 - NLM (National Library of Medicine)

avera mckennan hospital - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat 40 mg

미국 - 영어 - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat 40 mg - uloric is a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. uloric is not recommended for the treatment of asymptomatic hyperuricemia. uloric is contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with uloric 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 developmental effects were observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the mrhd (see data) . the esti