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

e. fougera & co. a division of fougera pharmaceuticals inc. - prednicarbate (unii: v901lv1k7d) (prednicarbate - unii:v901lv1k7d) - prednicarbate 1 mg in 1 g - prednicarbate cream 0.1% (emollient) is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. prednicarbate cream 0.1% (emollient) may be used with caution in pediatric patients 1 year of age or older. the safety and efficacy of drug use for longer than 3 weeks in this population have not been established. since safety and efficacy of prednicarbate cream 0.1% (emollient) have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended. prednicarbate cream 0.1% (emollient) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

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

fougera pharmaceuticals inc. - prednicarbate (unii: v901lv1k7d) (prednicarbate - unii:v901lv1k7d) - prednicarbate 1.0 mg in 1 g - prednicarbate ointment 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. prednicarbate ointment 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

Australia - English - Department of Health (Therapeutic Goods Administration)

red dot rescue - red-back spider antivenom -

Australia - English - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - red-back spider antivenom, quantity: 500 u - injection, solution - excipient ingredients: phenol; water for injections; sodium chloride - for the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a red back spider.

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

oceanside pharmaceuticals - prednicarbate (unii: v901lv1k7d) (prednicarbate - unii:v901lv1k7d) - prednicarbate emollient cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. prednicarbate emollient cream 0.1% may be used with caution in pediatric patients 1 year of age or older. the safety and efficacy of drug use for longer than 3 weeks in this population have not been established. since safety and efficacy of prednicarbate emollient cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended. prednicarbate emollient cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

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)

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)

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)

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)

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