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

physicians total care, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac sodium 1.035 mg in 1 ml - bromfenac ophthalmic solution is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction. bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

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

lupin pharmaceuticals, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [rhod] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. however, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. in rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and reduced postnatal growth at 0.9 mg/kg/day. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman. safety and efficacy in pediatric patients below the age of 18 years have not been established. there is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 70 years of age and older compared to younger adult patients.

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

akorn - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac 1.035 mg in 1 ml - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (cl

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

physicians total care, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac sodium 0.9 mg in 1 ml - bromday™ (bromfenac ophthalmic solution) 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects: pregnancy category c. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known effects of pr

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

sun pharmaceutical industries, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac 0.76 mg in 1 ml - bromsite (bromfenac ophthalmic solution) 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. none risk summary there are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. clinical considerations because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromsite during late pregnancy should be avoided. data animal data treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m2 basis) produced no structural teratogenicity in reproduction studies. however, e

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

fosun pharma usa inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects : pregnancy category c. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss.  there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects:

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

lupin pharmaceuticals, inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution, 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects pregnancy category c: reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman. safety and efficacy in pediatric patients below the age of 18 have not been established. there is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients.

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

alembic pharmaceuticals inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects: pregnancy category c . reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known effects of p

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

gland pharma limited - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects : pregnancy category c. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss.  there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known

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

aurobindo pharma limited - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects: pregnancy category c. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects: because of the known ef