USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.5 mg in 1 g - 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.

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.5 mg in 1 g - fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. the safety and efficacy of drug use for longer than 4 weeks in this population have not been established. the safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established. fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation (see precautions ).

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.05 mg in 1 g - fluticasone propionate ointment, 0.005% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. fluticasone propionate ointment, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

USA - engelsk - 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 teratogenici