США - англійська - 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

США - англійська - 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

США - англійська - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - 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 those patients with a history of hypersensitivity to any of the components in the preparation. pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluticasone propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. systemic embryofetal development studies were conducted in mice, rats and rabbits. subcutaneous doses of 15, 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 r

США - англійська - 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

США - англійська - 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

США - англійська - NLM (National Library of Medicine)

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.

США - англійська - 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.

США - англійська - NLM (National Library of Medicine)

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.

США - англійська - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - 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 comparis

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - salmeterol xinafoate, quantity: 36.32 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 250 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: - patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. - patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in copd.