Stany Zjednoczone - angielski - NLM (National Library of Medicine)

remedyrepack inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - 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. mice and rat

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug - 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

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - fluticasone propionate nasal spray, usp, is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. safety and effectiveness of fluticasone propionate nasal spray, usp, in children below 4 years of age have not been adequately established. fluticasone propionate nasal spray, usp, is contraindicated in patients with a hypersensitivity to any of its ingredients. please read this leaflet carefully before you start to take your medicine. it provides a summary of information on your medicine. for further information ask your doctor or pharmacist. rhinitis is a word that means inflammation of the lining of the nose. if you suffer from rhinitis, your nose becomes stuffy and runny. rhinitis can also make your nose itchy, and you may sneeze a lot. rhinitis can be caused by allergies to pollen, animals, molds, or other materials-or it may have a nonallergic cause. your doctor has prescribed fluticasone prop

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

blenheim pharmacal, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug - 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)] . 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 pro

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

rebel distributors corp - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - fluticasone propionate nasal spray, usp, is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. safety and effectiveness of fluticasone propionate nasal spray, usp, in children below 4 years of age have not been adequately established. fluticasone propionate nasal spray, usp, is contraindicated in patients with a hypersensitivity to any of its ingredients. please read this leaflet carefully before you start to take your medicine. it provides a summary of information on your medicine. for further information ask your doctor or pharmacist. read the complete instructions carefully and use only as directed. 1. shake the bottle gently and then remove the cap (figure 1). figure 1 2. it is necessary to prime the pump into the air the first time it is used, or when you have not used it for a week or more. to prime the pump, hold the bottle as shown with the nasal applicator pointing away from you and

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug - 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 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. fluticasone propionate nasal spray usp, 50 mcg (floo tik’ a sone proe’ pee oh nate) fluticasone propionate nasal spray is for use in your nose only. read this information before you start using your fluticasone propionate nasal spray. your fluticasone propionate nasal spray must be primed before you use it for the first time and when you have not used it for a week or more. how to prime your fluticasone propionate nasal spray: figure 1 figure 2 using your fluticasone propionate nasal spray: step 1: blow your nose to clear your nostrils. step 2: close 1 nostril. tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (figure 3). figure 3 step 3 : start to breathe in through your nose, and while breathing in press firmly and quickly down 1 time on the applicator to release the spray. to get a full dose, use your forefinger and middle finger to spray while supporting the base of the bottle with your thumb. avoid spraying in eyes. breathe in gently through the nostril (figure 4). figure 4 step 4 : breathe out through your mouth. step 5 : if a second spray is required in that nostril, repeat steps 2 through 4 . step 6 : repeat steps 2 through 5 in the other nostril. step 7 : wipe the nasal applicator with a clean tissue and replace the dust cap and the safety clip (figure 5). figure 5 do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty. before you throw the bottle away, you should talk to your healthcare provider to see if a refill is needed. do not take extra doses or stop taking fluticasone propionate nasal spray without talking to your healthcare provider. cleaning your fluticasone propionate nasal spray: your nasal spray should be cleaned at least 1 time each week. 1. remove the dust cap and then gently pull upwards to free the nasal applicator. 2. wash the applicator and dust cap under warm tap water. allow to dry at room temperature. 3. place the applicator and dust cap back on the bottle. 4. if the nasal applicator becomes blocked, it can be removed and left to soak in warm water. rinse the nasal applicator with cold tap water. dry the nasal applicator and place it back on the bottle. do not try to unblock the nasal applicator by inserting a pin or other sharp object. storing your fluticasone propionate nasal spray: this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50000258/01 revised february 2022

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

proficient rx lp - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - fluticasone propionate nasal spray, usp, is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. safety and effectiveness of fluticasone propionate nasal spray, usp, in children below 4 years of age have not been adequately established. fluticasone propionate nasal spray, usp, is contraindicated in patients with a hypersensitivity to any of its ingredients. please read this leaflet carefully before you start to take your medicine. it provides a summary of information on your medicine. for further information ask your doctor or pharmacist. rhinitis is a word that means inflammation of the lining of the nose. if you suffer from rhinitis, your nose becomes stuffy and runny. rhinitis can also make your nose itchy, and you may sneeze a lot. rhinitis can be caused by allergies to pollen, animals, molds, or other materials-or it may have a nonallergic cause. your doctor has prescribed fluticasone prop

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

akorn - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - 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/m2 basis, respectively. (see animal data .) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicit

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - 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. mice and rats at

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

fougera pharmaceuticals inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.5 mg in 1 ml - fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluticasone propionate lotion 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, 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 related effects on embryofetal toxicity or teratogenicity were noted at 15 μg/kg/day (less than the mrhd in adults based on body surface area compar