United States - English - 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 ).

United States - English - 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.

United States - English - 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.

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

padagis israel pharmaceuticals ltd - 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 ).

United States - English - 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

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

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

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

cosette pharmaceuticals, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.05 mg in 1 g - fluticasone propionate ointment, usp 0.005% is a 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. pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluticasone propionate ointment, 0.005% 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

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

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

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

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

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