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doc rx - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3) , description (11) ]. teratogenic effects pregnancy category c. there are no adequate and well-controlled trials with fluticasone propionate nasal spray, usp in pregnant women. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray, usp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasa

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

preferred pharmaceuticals, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older. fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3) , description (11)] . risk summary there are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m2 basis, respectively. (see animal data. ) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenici

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

preferred pharmaceuticals inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3), description (11)]. risk summary there are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m2 basis, respectively. (see animal data.) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not i

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asclemed usa, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [ see warnings and precautions (5.3) , description (11) ]. risk summary there are insufficient data on the use of fluticasone propionate in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m 2 basis, respectively. ( see animal data .) however, fluticasone propionate administered via

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

proficient rx lp - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3), description (11)]. risk summary there are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m2 basis, respectively. (see animal data.) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not i

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

remedyrepack inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions ( 5.3), description ( 11)] . risk summary there are insufficient data on the use of fluticasone propionate nasal spray in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m2 basis, respectively. (see animal data.) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose equivalent to the mrhdid on a mcg/m2 basis. (see animal data.) experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. the estimated risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.   data human data: following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery.   animal data: in embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species. omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 5 times the mrhdid of 200 mcg/day (on a mcg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). the rat no observed adverse effect level (noael) was observed at approximately equivalent to the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately equivalent to the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). the mouse noael was observed with a dose approximately 0.3 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). in an embryofetal development study with pregnant rats dosed by the nose-only inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately equivalent to the mrhdid (on a mcg/m2 basis with a maternal nose-only inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. the noael was observed with a dose approximately 0.25 times the mrhdid (on a mcg/m2 basis with a maternal nose only inhalation dose of 5.5 mcg/kg/day).   in an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.06 times the mrhdid and higher (on a mcg/m2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). teratogenicity was evident based upon a finding of cleft palate for 1 fetus at a dose 0.39 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 4 mcg/kg/day). the noael was observed in rabbit fetuses with a dose approximately 0.01 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. in a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (gestation day 17 to postpartum day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 2 times the mrhdid (on a mcg/m2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). risk summary there are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. low concentrations of other corticosteroids have been detected in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fluticasone propionate nasal spray and any potential adverse effects on the breastfed child from fluticasone propionate nasal spray or from the underlying maternal condition.   data animal data: subcutaneous administration of tritiated fluticasone propionate at a dose of 10 mcg/kg/day to lactating rats resulted in measurable levels in milk. the safety and effectiveness of fluticasone propionate nasal spray in children aged 4 years and older have been established [see adverse reactions ( 6.1), clinical pharmacology ( 12.3)] .six hundred fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in us clinical trials with fluticasone propionate nasal spray. the safety and effectiveness of fluticasone propionate nasal spray in children younger than 4 years have not been established. effects on growth controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. this effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. the potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving intranasal corticosteroids, including fluticasone propionate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. to minimize the systemic effects of intranasal corticosteroids, including fluticasone propionate nasal spray, each patient’s dosage should be titrated to the lowest dosage that effectively controls his/her symptoms. a 1-year placebo-controlled trial was conducted in 150 pediatric subjects (aged 3 to 9 years) to assess the effect of fluticasone propionate nasal spray (single daily dose of 200 mcg) on growth velocity. from the primary population receiving fluticasone propionate nasal spray (n = 56) and placebo (n = 52), the point estimate for growth velocity with fluticasone propionate nasal spray was 0.14 cm/year lower than placebo (95% ci: -0.54, 0.27 cm/year). thus, no statistically significant effect on growth was noted compared with placebo. no evidence of clinically relevant changes in hpa axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. the potential for fluticasone propionate nasal spray to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out. a limited number of subjects aged 65 years and older (n = 129) or 75 years and older (n = 11) have been treated with fluticasone propionate nasal spray in clinical trials. while the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. formal pharmacokinetic trials using fluticasone propionate nasal spray have not been conducted in subjects with hepatic impairment. since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. therefore, patients with hepatic disease should be closely monitored. formal pharmacokinetic trials using fluticasone propionate nasal spray have not been conducted in subjects with renal impairment.

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

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. the safety and efficacy of drug use for longer than 4 weeks in this population have not been established. the safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established. fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation (see precautions ).

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

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. the safety and efficacy of drug use for longer than 4 weeks in this population have not been established. the safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established. fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation (see precautions ).

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

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. the safety and efficacy of drug use for longer than 4 weeks in this population have not been established. the safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established. fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation (see precautions ).

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

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate ointment, 0.005% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. fluticasone propionate ointment, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. there are no adequate and well-controlled studies in pregnant women. therefore, fluticasone propionate ointment, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. systemic embryofetal development studies were conducted in mice, rats, and rabbits. subcutaneous does of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15. a teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the mrhd in adults based on body surface area comparisons) in this study. no treatment