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

teva pharmaceuticals usa, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - fluticasone propionate 55 ug - fluticasone propionate/salmeterol multidose dry powder inhaler (fs mdpi) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. fluticasone propionate/salmeterol mdpi should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2 -adrenergic agonist (laba). limitations of use : fluticasone propionate/salmeterol mdpi is not indicated for the relief of acute bronchospasm. fluticasone propionate/salmeterol mdpi is contraindicated in: - the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see warnings and precautions  (5.2)] . - patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see warnings and precautions (5.10) and description (11)] . risk summary there are no randomized clinical studies of fluticasone propionate/salmeterol mdpi or individual monoproducts, fluticasone propionate and salmeterol, in pregnant women. there are clinical considerations with the use of fluticasone propionate/salmeterol mdpi in pregnant women [see clinical considerations] . animal reproduction studies are available with the combination of fluticasone propionate and salmeterol as well as individual components. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the maximum recommended human daily inhaled dose (mrhdid) on a mcg/m2 basis [see data] . however, fluticasone propionate administered via inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the mrhdid on a mcg/m2 basis [see data] . experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. oral administration of salmeterol to pregnant rabbits caused teratogenicity characteristic of beta-adrenoceptor stimulation at maternal doses approximately 700 times the mrhdid on a mcg/m2 basis. these adverse effects generally occurred at large multiples of the mrhdid when salmeterol was administered by the oral route to achieve high systemic exposures. no such effects occurred at an oral salmeterol dose approximately 420 times the mrhdid [see data] . the estimated risk of major birth defects and miscarriage for the indicated population is unknown. 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. clinical considerations disease‑associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. data animal data fluticasone propionate and salmeterol:  in an embryo/fetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1000, 30/0, 10/100, 30/1000, and 100/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects. omphalocele, increased embryo/fetal deaths, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, when combining fluticasone propionate at a dose approximately 2 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and a dose of salmeterol at approximately 3500 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 10,000 mcg/kg/day). the rat no observed adverse effect level (noael) was observed when combining fluticasone propionate at a dose 0.6 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 30 mcg/kg/day) and a dose of salmeterol at approximately 350 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 1000 mcg/kg/day). in an embryo/fetal development study with pregnant mice that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1400, 40/0, 10/200, 40/1400, or 150/10,000 mcg/kg/day (as fluticasone propionate/salmeterol) during the period of organogenesis, findings were generally consistent with the individual monoproducts and there was no exacerbation of expected fetal effects. cleft palate, fetal death, increased implantation loss, and delayed ossification were observed in mouse fetuses when combining fluticasone propionate at a dose approximately 1.4 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 150 mcg/kg/day) and salmeterol at a dose approximately 1470 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 10,000 mcg/kg/day). no developmental toxicity was observed at combination doses of fluticasone propionate up to approximately 0.8 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 40 mcg/kg) and doses of salmeterol up to approximately 420 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 1400 mcg/kg). fluticasone propionate:   in embryo/fetal 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 2 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). the rat noael was observed at approximately 0.6 times 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 0.5 times 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 0.16 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). in an embryo/fetal development study with pregnant rats dosed by the 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 0.5 times the mrhdid (on a mcg/m2 basis with a maternal inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. the noael was observed with a dose approximately 0.1 times the mrhdid (on a mcg/m2 basis with a maternal inhalation dose of 5.5 mcg/kg/day). in an embryo/fetal 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 0.02 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 approximately 0.2 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 0.004 times the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). in a pre- and post-natal development study in pregnant rats dosed by the subcutaneous route 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 approximate equivalence to the mrhdid (on a mcg/m2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. salmeterol: in three embryo/fetal development studies, pregnant rabbits received oral administration of salmeterol at doses ranging from 100 to 10,000 mcg/kg/day during the period of organogenesis. in pregnant dutch rabbits administered salmeterol doses approximately 700 times the mrhdid (on a mcg/m2 basis at maternal oral doses of 1000 mcg/kg/day and higher), fetal toxic effects were observed characteristically resulting from beta‑adrenoceptor stimulation. these included precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones. no such effects occurred at a salmeterol dose approximately 420 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 600 mcg/kg/day). new zealand white rabbits were less sensitive since only delayed ossification of the frontal cranial bones was seen at a salmeterol dose approximately 7,000 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 10,000 mcg/kg/day). in two embryo/fetal development studies, pregnant rats received salmeterol by oral administration at doses ranging from 100 to 10,000 mcg/kg/day during the period of organogenesis. salmeterol produced no maternal toxicity or embryo/fetal effects at doses up to 3500 times the mrhdid (on a mcg/m2 basis at maternal oral doses up to 10,000 mcg/kg/day). in a peri-and post-natal development study in pregnant rats dosed by the oral route from late gestation through delivery and lactation, salmeterol at a dose 3500 times the mrhdid (on mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day) was fetotoxic and decreased the fertility of survivors. salmeterol xinafoate crossed the placenta following oral administration to mice and rats. risk summary there are no available data on the presence of fluticasone propionate or salmeterol in human milk, the effects on the breastfed child, or the effects on milk production. other corticosteroids have been detected in human milk. however, fluticasone propionate and salmeterol concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fluticasone propionate/salmeterol mdpi and any potential adverse effects on the breastfed child from fluticasone propionate/salmeterol mdpi or from the underlying maternal condition. data animal data subcutaneous administration of tritiated fluticasone propionate at a dose in lactating rats approximately 0.2 times the mrhdid for adults (on a mcg/m2 basis) resulted in measurable levels in milk.  oral administration of salmeterol at a dose in lactating rats approximately 2900 times the mrhdid for adults (on a mcg/m2 basis) resulted in measurable levels in milk. the safety and effectiveness of fluticasone propionate/salmeterol mdpi have been established for the treatment of asthma in pediatric patients aged 12 years and older whose asthma (1) is inadequately controlled on a long term asthma control medication or (2) warrants initiation of treatment with both an ics and a laba.  use of fluticasone propionate/salmeterol mdpi in pediatric patients aged 12 to 17 years for this indication is supported by evidence from two adequate and well-controlled trials in pediatric patients 12 years old and older with persistent symptomatic asthma despite ics or ics/laba therapy (trials 1 and 2) [see clinical studies (14)].  in these trials, 58 adolescents received fluticasone propionate/salmeterol mdpi one inhalation twice daily. the safety and effectiveness of fluticasone propionate/salmeterol mdpi have not been established in pediatric patients younger than 12 years of age for the treatment of asthma. effectiveness was not demonstrated in one adequate and well-controlled study conducted in 211 patients aged 4 to 11 years with persistent asthma on a stable asthma regimen who were treated with fluticasone propionate/salmeterol mdpi 55 mcg/14 mcg one inhalation twice daily. effect on growth inhaled corticosteroids, including fluticasone propionate, a component of this product, may cause a reduction in growth velocity in adolescents [see warning and precautions (5.13)] . the growth of pediatric patients receiving ics, including fluticasone propionate/salmeterol mdpi, should be monitored. if an adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. in such patients, the potential growth effects of prolonged ics treatment should be weighed against the clinical benefits obtained. to minimize the systemic effects of ics, including fluticasone propionate/salmeterol mdpi, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see dosage and administration (2)]. no overall differences in safety or effectiveness were observed in data collected in 54 subjects aged 65 years and older versus younger subjects who were treated with fluticasone propionate/salmeterol mdpi in placebo-controlled phase 2 and 3 asthma studies. formal pharmacokinetic studies using fluticasone propionate/salmeterol mdpi have not been conducted in patients with hepatic impairment. however, since both fluticasone propionate and salmeterol are predominantly cleared by hepatic metabolism [see clinical pharmacology (12.3)] , impairment of liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma. therefore, patients with hepatic impairment should be closely monitored. formal pharmacokinetic studies using fluticasone propionate/salmeterol mdpi have not been conducted in patients with renal impairment. instructions for use fluticasone propionate and salmeterol inhalation powder 55 mcg/14 mcg fluticasone propionate and salmeterol inhalation powder 113 mcg/14 mcg fluticasone propionate and salmeterol inhalation powder 232 mcg/14 mcg for oral inhalation use   your fluticasone propionate/salmeterol inhalation powder inhaler when you are ready to use your inhaler for the first time, remove the inhaler from the foil pouch. there are 2 main parts of your inhaler including the: - white inhaler with the mouthpiece. see figure a. - yellow cap that covers the mouthpiece of the inhaler. see figure a. there is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. see figure a. figure a   - your inhaler contains 60 doses (inhalations). see figure b. - the dose counter shows the number of doses left in your inhaler. - when there are 20 doses left, the color of the numbers on the dose counter will change to red and you should refill your prescription or ask your healthcare provider for another prescription. - when the dose counter displays ‘0’ your inhaler is empty and you should stop using the inhaler and throw it away. see figure b. figure b important: - always close the cap after each inhalation so your inhaler will be ready for you to take your next dose . do not open the cap unless you are ready for your next dose. - you will hear a “click” sound when the cap is opened all the way. if you do not hear the “click” sound the inhaler may not be activated to give you a dose of medicine. - this inhaler does not have an activation button or medicine canister. when you open the cap, a dose of fluticasone propionate/salmeterol inhalation powder will be activated for delivery of the medicine. - do not use a spacer or volume holding chamber with the inhaler. this inhaler does not need priming. using your fluticasone propionate/salmeterol inhalation powder inhaler: important: make sure the cap is closed before you start using your inhaler. step 1. open - hold the inhaler upright and open the yellow cap all the way until it “clicks”. see figure c. - each time you open the yellow cap and it “clicks”, 1 dose of fluticasone propionate/salmeterol inhalation powder is ready to be inhaled.   figure c   remember: - for the correct use of your inhaler, hold it upright as you open the yellow cap. see figure d. - do not hold the inhaler in any other way as you open the yellow cap. - do not open the yellow cap until you are ready to take a dose of fluticasone propionate/salmeterol inhalation powder. figure d   step 2. inhale - before you inhale, breathe out (exhale) through your mouth and push as much air from your lungs as you can. see figure e. - do not exhale into the inhaler mouthpiece. figure e - put the mouthpiece in your mouth and close your lips tightly around it. see figure f.   figure f - do not block the vent above the mouthpiece with your lips or fingers. see figure g.   figure g   - breathe in quickly and deeply through your mouth to deliver the dose of medicine to your lungs. - remove the inhaler from your mouth. - hold your breath for about 10 seconds or for as long as you comfortably can. - your inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. do not take an extra dose from the inhaler even if you do not taste or feel the medicine.   step 3.  close figure h - close the yellow cap firmly over the mouthpiece. see figure h. - make sure you close the yellow cap after each inhalation so that the inhaler will be ready for your next dose. - rinse your mouth with water without swallowing after each inhalation.   how should i store the fluticasone propionate/salmeterol inhalation powder inhaler? - store your inhaler at room temperature between 59ºf and 77ºf (15ºc and 25ºc). - avoid exposure to extreme heat, cold, or humidity. - store your inhaler in the unopened foil pouch and only open when ready for use. - keep the yellow cap on the inhaler closed during storage. - keep your inhaler dry and clean at all times. - keep your inhaler and all medicines out of the reach of children.   cleaning your fluticasone propionate/salmeterol inhalation powder inhaler - do not wash or put any part of your inhaler in water. replace your inhaler if washed or placed in water. - your inhaler contains a powder and must be kept clean and dry at all times. - you can clean the mouthpiece if needed using a dry cloth or tissue. routine cleaning is not required.   replacing your fluticasone propionate/salmeterol inhalation powder inhaler - immediately replace your inhaler if the mouthpiece cover is damaged or broken. never take the inhaler apart. - the dose counter on the back of your inhaler shows how many doses you have left. - when there are 20 doses left, the color of the numbers on the dose counter will change to red and you should refill your prescription or ask your healthcare provider for another prescription. - when the counter displays ‘0’ your inhaler is empty and you should stop using the inhaler and throw it away. - throw away your inhaler 30 days after opening the foil pouch, when the dose counter displays ‘0’, or after the expiration date on the product, whichever comes first.   important information - do not open the yellow cap unless you are taking a dose. repeatedly opening and closing the cap without inhaling a dose will waste the medicine and may damage your inhaler. - your inhaler contains dry powder so it is important that you do not blow or breathe into it.   support - if you have any questions about your fluticasone propionate/salmeterol inhalation powder inhaler or how to use your inhaler, go to the reference branded product website at www.myairduo.com, or call 1-888-482-9522. these instructions for use have been approved by the u.s. food and drug administration. distributed by: teva pharmaceuticals usa, inc. parsippany, nj 07054 ©2021 teva respiratory, llc. all rights reserved. fpsifu-005 revised: july 2021

United States - English - 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

United States - English - 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

United States - English - 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

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apotex corp. - 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 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)

golden state medical supply, 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 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.

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padagis israel pharmaceuticals ltd - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.05 mg in 1 g - 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 patients with a history of hypersensitivity to any of the components in the preparation. risk summary there are no available data on fluticasone propionate ointment use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroids during pregnancy (see data) . advise pregnant women that fluticasone propionate ointment may increase the risk of having a low birthweight infant and to use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, subcutaneous administration of fluticasone propionate to pregnant mice, rats, and rabbits during organogenesis caused malformations characteristic of corticosteroids in each species (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of fluticasone propionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of fluticasone propionate ointment. the background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. however, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight infants. animal data in embryo-fetal development studies, pregnant rabbits, rats, and mice received subcutaneous doses of fluticasone propionate during organogenesis at doses up to 4, 100, and 150 μg/kg/day, respectively. a malformation characteristic of corticosteroids (cleft palate) was noted at the high dose in each species. additional adverse effects were noted in rats and rabbits. decreased fetal weights and retarded skeletal ossification were noted in rabbits at 4 μg/kg/day and rats at 100 μg/kg/day. maternal toxicity and omphalocele were also noted in rats at 100 μg/kg/day. no malformations or developmental toxicity was noted in rabbits at 0.57 μg/kg/day, in rats at 10 μg/kg/day, or in mice at 15 μg/kg/day. fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats. risk summary there are no data on the presence of fluticasone propionate in human milk, its effects on the breastfed infant, or its effects on milk production. it is not known whether topical administration of fluticasone propionate ointment could result in sufficient systemic absorption to produce detectable quantities in human milk (see clinical considerations ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluticasone propionate ointment and any potential adverse effects on the breastfed child from fluticasone propionate ointment or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply fluticasone propionate ointment directly to the nipple and areola prior to breastfeeding to avoid direct infant exposure [see use in specific populations (8.4) ]. the safety and effectiveness of fluticasone propionate ointment have not been established in pediatric patients. use of fluticasone propionate ointment in pediatric patients is not recommended. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic effects when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see warnings and precautions (5.1) ]. in a trial of 35 pediatric subjects treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 subjects who had normal testing prior to treatment. it is not known if these subjects had recovery of adrenal function because follow-up testing was not performed. the decreased responsiveness of cosyntropin testing was not correlated to age of subject, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate. in the above trial, telangiectasia on the face was noted in one subject on the eighth day of a 4-week treatment period. facial use was discontinued and the telangiectasia resolved. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. a limited number of patients above 65 years of age (n=203) have been treated with fluticasone propionate ointment in us and non-us clinical trials. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.

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glenmark pharmaceuticals inc., usa - 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 mcg/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 mcg/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 mcg/kg/day (less than the mrhd in adults based on body surface area comparisons). subcutaneous doses of 10, 30 and 100 mcg/kg/day of fluticasone propionate were administered to pregnant female rats in two embryofetal development studies (one study administered fluticasone propionate from gestation days 6 to 15 and the other study from gestation days 7 to 17). in the presence of maternal toxicity, fetal effects noted at 100 mcg/kg/day (less than the mrhd in adults based on body surface area comparisons) included decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 10 mcg/kg/day (less than the mrhd in adults based on body surface area comparisons). subcutaneous doses of 0.08, 0.57 and 4 mcg/kg/day of fluticasone propionate were administered to pregnant female rabbits from gestation days 6 to 18. fetal effects noted at 4 mcg/kg/day (less than the mrhd in adults based on body surface area comparisons) included decreased fetal weights, cleft palate and retarded skeletal ossification. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 0.57 mcg/kg/day (less than the mrhd in adults based on body surface area comparisons). oral doses of 3, 30 and 300 mcg/kg/day fluticasone propionate were administered to pregnant female rabbits from gestation days 8 to 20. no fetal or teratogenic effects were noted at oral doses up to 300 mcg/kg/day (less than the mrhd in adults based on body surface area comparisons) in this study. however, no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration. fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats. systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when fluticasone propionate lotion is administered to a nursing woman. fluticasone propionate lotion may be used in pediatric patients as young as 3 months of age. the safety and effectiveness of fluticasone propionate lotion in pediatric patients below 3 months of age have not been established. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic effects when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see warnings and precautions (5.1)]. in an hpa axis suppression trial, none of the 40 evaluable pediatric subjects, 4 months old to < 6 years old, with moderate to severe atopic dermatitis covering ≥ 35% body surface area (bsa) who were treated with an exaggerated dosing regimen (twice daily) of fluticasone propionate lotion experienced adrenal suppression (defined as a 30-minute post-stimulation cortisol level ≤18 micrograms/dl) [see warnings and precautions (5.1) and clinical pharmacology (12.2)]. in another hpa axis suppression trial, one of 49 (2%) evaluable pediatric subjects, 3 months to 11 months old, with moderate to severe atopic dermatitis covering ≥ 35% body surface area (bsa) who applied an exaggerated dosing regimen (twice daily) of fluticasone propionate lotion experienced reversible adrenal suppression (defined as a 30-minute post-stimulation cortisol level ≤18 micrograms/dl) following 4 weeks of therapy [see warnings and precautions (5.1)and clinical pharmacology (12.2)]. systemic effects such as cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high-potency topical corticosteroids, or concomitant use of more than one corticosteroid product. local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis unless directed by a physician. fluticasone propionate lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing. a limited number of patients above 65 years of age have been treated with fluticasone propionate lotion in us and non-us clinical trials. specifically only 8 patients above 65 years of age were treated with fluticasone propionate lotion in controlled clinical trials. the number of patients is too small to permit separate analyses of efficacy and safety.

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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 teratogenici

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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