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

amneal pharmaceuticals ny llc - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion, 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion, 0.05% is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. teratogenic effects pregnancy category c difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 to 10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. at 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. it is difficult to extrapolate these doses of difluprednate to maximum daily human doses of difluprednate, since difluprednate is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. however, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. it is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. caution should be exercised when difluprednate is administered to a nursing woman. difluprednate was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. a similar safety profile was observed in pediatric patients comparing difluprednate to prednisolone acetate ophthalmic suspension, 1%. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

dr. reddy's laboratories inc. - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion (0.05%) is a topical corticosteroid, indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion (0.05%) is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate ophthalmic emulsion (0.05%), as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. pregnancy category c. difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 to 10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered t

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

cipla usa inc. - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. teratogenic effects pregnancy category c. difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered t

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

exelan pharmaceuticals, inc. - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. teratogenic effects pregnancy category c. difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered t

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

sandoz inc - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate ophthalmic emulsion, 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis. the use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. pregnancy category c difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic

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

physicians total care, inc. - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate 0.5 mg in 1 ml - durezol (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. the use of durezol, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. teratogenic effects pregnancy category c. difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal) anomalies when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 μg/kg/day. the no-observed-effect-level (noel) for these effects was 1 μg/kg/day, and 10 μg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. treatment o

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

alcon laboratories, inc. - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - difluprednate 0.5 mg in 1 ml - durezol® (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. durezol is also indicated for the treatment of endogenous anterior uveitis. the use of durezol, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. pregnancy category c difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the t

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

novartis pharmaceuticals corporation - difluprednate (unii: s8a06qg2qe) (difluprednate - unii:s8a06qg2qe) - durezol® (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. durezol is also indicated for the treatment of endogenous anterior uveitis. the use of durezol, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. pregnancy category c difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1 to 10 mcg/kg/day. the no-observed-effect-level (noel) for these effects was 1 mcg/kg/day and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the

Canada - English - Health Canada

novartis pharmaceuticals canada inc - difluprednate - emulsion - 0.05% - difluprednate 0.05% - corticosteroids

Bangladesh - English - DGDA (Directorate General of Drug Administration)

aristopharma limited - difluprednate - ophthalmic emulsion - .05 gm/100 ml