Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate cream, usp 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluticasone propionate cream, usp 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, usp 0.05% in pediatric patients below 3 months of age have not been established. fluticasone propionate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - 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)]. teratogenic effects pregnancy category c. there are no adequate and well-controlled trials with fluticasone propionate nasal spray 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 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 nasal spray. mice and rats at fluticasone propionate doses approximately 1 and 4 times, respectively, the maximum recommended human daily intranasal dose (mrhdid) for adults (on a mg/m2 basis at maternal subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. no teratogenicity was seen in rats at doses up to 3 times the mrhdid (on a mg/m2 basis at maternal inhalation doses up to 68.7 mcg/kg/day). in rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately 0.3 times the mrhdid for adults (on a mg/m2 basis at a maternal subcutaneous dose of 4 mcg/kg/day). however, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the mrhdid for adults (on a mg/m2 basis at a maternal oral dose up to 300 mcg/kg/day). no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see clinical pharmacology (12.3)]. fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. in addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. nonteratogenic effects hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. such infants should be carefully monitored. it is not known whether fluticasone propionate is excreted in human breast milk. however, other corticosteroids have been detected in human milk. subcutaneous administration to lactating rats of tritiated fluticasone propionate at a dose approximately 0.4 times the mrhdid for adults on a mg/m2 basis resulted in measurable radioactivity in milk. since there are no data from controlled trials on the use of intranasal fluticasone propionate nasal spray by nursing mothers, caution should be exercised when fluticasone propionate nasal spray is administered to a nursing woman. 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.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. fluticasone propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluticasone propionate ointment 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 doses of 15 μg/kg/day, 45 μg/kg/day 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 μg/kg/day and 150 μg/kg/day (less than the mrhd in adults based on body surface area comparisons) i

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

proficient rx lp - 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)] . there are no adequate and well-controlled trials with fluticasone propionate nasal spray 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 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 nasal spray. mice and rats at fluticasone propionate doses approximately 1 and 4 times, respect

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

proficient rx lp - 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.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

prasco laboratories - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - fluticasone propionate/salmeterol diskus is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. fluticasone propionate/salmeterol diskus should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). important limitation of use fluticasone propionate/salmeterol diskus is not indicated for the relief of acute bronchospasm. fluticasone propionate/salmeterol diskus inhalation powder 250/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. fluticasone propionate/salmeterol diskus inhalation powder 250/50 mcg is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. fluticasone propionate/salmeterol diskus inhalation po

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

nucare pharmaceuticals,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) ]. 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 nasal spray, usp.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

nucare 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/m 2 basis, respectively. ( see animal data. ) however, fluticasone propionate administered via nose-only inhalation to rats decr

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

proficient rx lp - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - fluticasone propionate/salmeterol diskus is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. fluticasone propionate/salmeterol diskus should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an ics and long-acting beta2 -adrenergic agonist (laba). important limitation of use fluticasone propionate/salmeterol diskus is not indicated for the relief of acute bronchospasm. fluticasone propionate/salmeterol diskus inhalation powder 250/50 mcg is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and/or emphysema. fluticasone propionate/salmeterol diskus inhalation powder 250/50 mcg is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. fluticasone propionate/salmeterol diskus inhalation po

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

direct_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 is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3), description (11)]. 8.1 pregnancy 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 induc