New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone furoate 100ug;   - powder for inhalation - 100 mcg - active: fluticasone furoate 100ug   excipient: lactose monohydrate - indicated for maintenance treatment of asthma in patients aged not less than 12 years

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone furoate 200ug;   - powder for inhalation - 200 mcg - active: fluticasone furoate 200ug   excipient: lactose monohydrate - indicated for maintenance treatment of asthma in patients aged not less than 12 years

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

a-s medication solutions - 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)

a-s medication solutions - 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 powder 250/50 mcg twice daily is the only approved dosage for the treatment of copd because an efficacy advantage of the higher strength fluticasone propionate/salmeterol diskus inhalation powder 500/50 mcg over fluticasone propionate/salmeterol diskus inhalation powder 250/50 mcg has not been demonstrated. important limitation of use fluticasone propionate/salmeterol diskus is not indicated for the relief of acute bronchospasm. the use of fluticasone propionate/salmeterol diskus is contraindicated in the following conditions: risk summary there are insufficient data on the use of fluticasone propionate/salmeterol diskus or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. there are clinical considerations with the use of fluticasone propionate/salmeterol diskus in pregnant women. (see clinical considerations.) 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 50 times the mrhdid on an auc 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 20 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 embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. labor and delivery: there are no human studies evaluating the effects of fluticasone propionate/salmeterol diskus during labor and delivery. because of the potential for beta-agonist interference with uterine contractility, use of fluticasone propionate/salmeterol diskus during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. data human data: fluticasone propionate: following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery. animal data: fluticasone propionate and salmeterol: in an embryofetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1,000; 30/0; 10/100; 30/1,000; 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 embryofetal 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 equivalent to the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and salmeterol at a dose approximately 970 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 approximately 0.3 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 30 mcg/kg/day) and salmeterol at a dose approximately 100 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 1,000 mcg/kg/day). in an embryofetal development study with pregnant mice that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1,400; 40/0; 10/200; 40/1,400; 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 0.7 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 150 mcg/kg/day) and salmeterol at a dose approximately 490 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 0.2 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 40 mcg/kg) and doses of salmeterol up to approximately 70 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 1,400 mcg/kg). fluticasone propionate: 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 equivalent to the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). the rat noael was observed at approximately 0.3 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 0.2 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 0.07 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 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 0.25 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 0.05 times the mrhdid (on a mcg/m2 basis with a maternal 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 0.012 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 0.08 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 0.002 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 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 0.5 times the mrhdid (on a mcg/m2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). salmeterol: in 3 embryofetal 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 50 times the mrhdid (on an auc basis at maternal oral doses of 1,000 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 20 times the mrhdid (on an auc 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 2,000 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 10,000 mcg/kg/day). in 2 embryofetal 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 embryofetal effects at doses up to 973 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 973 times the mrhdid (on a 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 diskus and any potential adverse effects on the breastfed child from fluticasone propionate/salmeterol diskus 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. oral administration of salmeterol at a dose of 10,000 mcg/kg/day to lactating rats resulted in measurable levels in milk. use of fluticasone propionate/salmeterol diskus 100/50 mcg in patients aged 4 to 11 years is supported by extrapolation of efficacy data from older subjects and by safety and efficacy data from a trial of fluticasone propionate/salmeterol diskus 100/50 mcg in children with asthma aged 4 to 11 years [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . the safety and effectiveness of fluticasone propionate/salmeterol diskus in children with asthma younger than 4 years have not been established. ics, including fluticasone propionate, a component of fluticasone propionate/salmeterol diskus, may cause a reduction in growth velocity in children and adolescents [see warnings and precautions (5.14)] . the growth of pediatric patients receiving orally inhaled corticosteroids, including fluticasone propionate/salmeterol diskus, should be monitored. a 52-week placebo-controlled trial to assess the potential growth effects of fluticasone propionate inhalation powder (flovent rotadisk) at 50 and 100 mcg twice daily was conducted in the u.s. in 325 prepubescent children (244 males and 81 females) aged 4 to 11 years. the mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mcg group (n = 98), and 5.66 cm/year in the 100-mcg group (n = 89). an imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. a separate subset analysis of children who remained prepubertal during the trial revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). in children aged 8.5 years, the mean age of children in this trial, the range for expected growth velocity is: boys – 3rd percentile = 3.8 cm/year, 50th percentile = 5.4 cm/year, and 97th percentile = 7.0 cm/year; girls – 3rd percentile = 4.2 cm/year, 50th percentile = 5.7 cm/year, and 97th percentile = 7.3 cm/year. the clinical relevance of these growth data is not certain. if a child or 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. the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. to minimize the systemic effects of orally inhaled corticosteroids, including fluticasone propionate/salmeterol diskus, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see dosage and administration (2.1)] . clinical trials of fluticasone propionate/salmeterol diskus for asthma did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects with asthma respond differently than younger subjects. of the total number of subjects in clinical trials receiving fluticasone propionate/salmeterol diskus for copd, 1,621 were aged 65 years and older and 379 were aged 75 years and older. subjects with copd aged 65 years and older had a higher incidence of serious adverse events compared with subjects younger than 65 years. although the distribution of adverse events was similar in the 2 age groups, subjects older than 65 years experienced more severe events. in two 1-year trials, the excess risk of pneumonia that was seen in subjects treated with fluticasone propionate/salmeterol diskus compared with those treated with salmeterol was greater in subjects older than 65 years than in subjects younger than 65 years [see adverse reactions (6.2)] . as with other products containing beta2 -agonists, special caution should be observed when using fluticasone propionate/salmeterol diskus in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta2 -agonists. based on available data for fluticasone propionate/salmeterol diskus or its active components, no adjustment of dosage of fluticasone propionate/salmeterol diskus in geriatric patients is warranted. no relationship between fluticasone propionate systemic exposure and age was observed in 57 subjects with copd (aged 40 to 82 years) given 250 or 500 mcg twice daily. formal pharmacokinetic studies using fluticasone propionate/salmeterol diskus have not been conducted in patients with hepatic impairment. however, since both fluticasone propionate and salmeterol are predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma. therefore, patients with hepatic disease should be closely monitored. formal pharmacokinetic studies using fluticasone propionate/salmeterol diskus have not been conducted in patients with renal impairment. instructions for use fluticasone propionate/salmeterol diskus inhalation powder for oral inhalation use read this instructions for use before you start using fluticasone propionate/salmeterol diskus and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. your fluticasone propionate/salmeterol diskus inhaler important information about your fluticasone propionate/salmeterol diskus inhaler: how to use your fluticasone propionate/salmeterol diskus inhaler follow these steps every time you use fluticasone propionate/salmeterol diskus. step 1. open your fluticasone propionate/salmeterol diskus. step 2. slide the lever until you hear it click. figure c follow the instructions below so you will not accidentally waste a dose: step 3. inhale your medicine. figure d figure e step 4. close the diskus. figure f step 5. rinse your mouth. the counter on top of the diskus shows you how many doses are left. after you have taken 55 doses, the numbers 5 to 0 will show in red. see figure h. these numbers warn you there are only a few doses left and are a reminder to get a refill. this instructions for use has been approved by the u.s. food and drug administration               revised: july 2023

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

a-s medication solutions - 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)

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - 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)]

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

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - 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)]

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

bryant ranch prepack - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt) - 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)]

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

hikma pharmaceuticals usa inc. - salmeterol xinafoate (unii: 6ew8q962a5) (salmeterol - unii:2i4bc502bt), fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - 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. fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg twice daily is the only approved dosage for the treatment of copd because an efficacy advantage of the higher strength fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg over fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg has not been demonstrated. important limitation of use fluticasone propionate and salmeterol inhalation powder is not indicated for the relief of acute bronchospasm. the use of fluticasone propionate and salmeterol inhalation powder is contraindicated in the following conditions: risk summary there are insufficient data on the use of fluticasone propionate and salmeterol inhalation powder or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. there are clinical considerations with the use of fluticasone propionate and salmeterol inhalation powder in pregnant women (see clinical considerations ). 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 50 times the mrhdid on an auc 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 20 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 embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. labor and delivery: there are no human studies evaluating the effects of fluticasone propionate and salmeterol inhalation powder during labor and delivery. because of the potential for beta-agonist interference with uterine contractility, use of fluticasone propionate and salmeterol inhalation powder during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. data human data: fluticasone propionate: following inhaled administration, fluticasone propionate was detected in the neonatal cord blood after delivery. animal data: fluticasone propionate and salmeterol: in an embryofetal development study with pregnant rats that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1,000; 30/0; 10/100; 30/1,000; 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 embryofetal 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 equivalent to the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 100 mcg/kg/day) and salmeterol at a dose approximately 970 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 approximately 0.3 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 30 mcg/kg/day) and salmeterol at a dose approximately 100 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 1,000 mcg/kg/day). in an embryofetal development study with pregnant mice that received the combination of subcutaneous administration of fluticasone propionate and oral administration of salmeterol at doses of 0/1,400; 40/0; 10/200; 40/1,400; 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 0.7 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 150 mcg/kg/day) and salmeterol at a dose approximately 490 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 0.2 times the mrhdid (on a mcg/m2 basis at a maternal subcutaneous dose of 40 mcg/kg) and doses of salmeterol up to approximately 70 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 1,400 mcg/kg). fluticasone propionate: 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 equivalent to the mrhdid (on a mcg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). the rat noael was observed at approximately 0.3 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 0.2 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 0.07 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 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 0.25 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 0.05 times the mrhdid (on a mcg/m2 basis with a maternal 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 0.012 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 0.08 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 0.002 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 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 0.5 times the mrhdid (on a mcg/m2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). salmeterol: in 3 embryofetal 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 50 times the mrhdid (on an auc basis at maternal oral doses of 1,000 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 20 times the mrhdid (on an auc 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 2,000 times the mrhdid (on a mcg/m2 basis at a maternal oral dose of 10,000 mcg/kg/day). in 2 embryofetal 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 embryofetal effects at doses up to 973 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 973 times the mrhdid (on a 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 and salmeterol inhalation powder and any potential adverse effects on the breastfed child from fluticasone propionate and salmeterol inhalation powder 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. oral administration of salmeterol at a dose of 10,000 mcg/kg/day to lactating rats resulted in measurable levels in milk. use of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg in patients aged 4 to 11 years is supported by extrapolation of efficacy data from older subjects and by safety and efficacy data from a trial of fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg in children with asthma aged 4 to 11 years [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . the safety and effectiveness of fluticasone propionate and salmeterol inhalation powder in children with asthma younger than 4 years have not been established. ics, including fluticasone propionate, a component of fluticasone propionate and salmeterol inhalation powder, may cause a reduction in growth velocity in children and adolescents [see warnings and precautions (5.14)] . the growth of pediatric patients receiving orally inhaled corticosteroids, including fluticasone propionate and salmeterol inhalation powder, should be monitored. a 52-week placebo-controlled trial to assess the potential growth effects of fluticasone propionate inhalation powder (flovent rotadisk) at 50 and 100 mcg twice daily was conducted in the u.s. in 325 prepubescent children (244 males and 81 females) aged 4 to 11 years. the mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mcg group (n = 98), and 5.66 cm/year in the 100-mcg group (n = 89). an imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. a separate subset analysis of children who remained prepubertal during the trial revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). in children aged 8.5 years, the mean age of children in this trial, the range for expected growth velocity is: boys – 3rd percentile = 3.8 cm/year, 50th percentile = 5.4 cm/year, and 97th percentile = 7.0 cm/year; girls – 3rd percentile = 4.2 cm/year, 50th percentile = 5.7 cm/year, and 97th percentile = 7.3 cm/year. the clinical relevance of these growth data is not certain. if a child or 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. the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. to minimize the systemic effects of orally inhaled corticosteroids, including fluticasone propionate and salmeterol inhalation powder, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see dosage and administration (2.1)] . clinical trials of fluticasone propionate and salmeterol inhalation powder for asthma did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects with asthma respond differently than younger subjects. of the total number of subjects in clinical trials receiving fluticasone propionate and salmeterol inhalation powder for copd, 1,621 were aged 65 years and older and 379 were aged 75 years and older. subjects with copd aged 65 years and older had a higher incidence of serious adverse events compared with subjects younger than 65 years. although the distribution of adverse events was similar in the 2 age groups, subjects older than 65 years experienced more severe events. in two 1-year trials, the excess risk of pneumonia that was seen in subjects treated with fluticasone propionate and salmeterol inhalation powder compared with those treated with salmeterol was greater in subjects older than 65 years than in subjects younger than 65 years [see adverse reactions (6.2)] . as with other products containing beta2 -agonists, special caution should be observed when using fluticasone propionate and salmeterol inhalation powder in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta2 -agonists. based on available data for fluticasone propionate and salmeterol inhalation powder or its active components, no adjustment of dosage of fluticasone propionate and salmeterol inhalation powder in geriatric patients is warranted. no relationship between fluticasone propionate systemic exposure and age was observed in 57 subjects with copd (aged 40 to 82 years) given 250 or 500 mcg twice daily. formal pharmacokinetic studies using fluticasone propionate and salmeterol inhalation powder have not been conducted in patients with hepatic impairment. however, since both fluticasone propionate and salmeterol are predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma. therefore, patients with hepatic disease should be closely monitored. formal pharmacokinetic studies using fluticasone propionate and salmeterol inhalation powder have not been conducted in patients with renal impairment. instructions for use fluticasone propionate and salmeterol inhalation powder (floo tik’ a sone proe’ pee oh nate and sal mee’ ter ol) for oral inhalation rx only read this instructions for use before you start using fluticasone propionate and salmeterol inhalation powder and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. your fluticasone propionate and salmeterol inhalation powder inhaler figure a important information about your fluticasone propionate and salmeterol inhalation powder inhaler: how to use your fluticasone propionate and salmeterol inhalation powder inhaler follow these steps every time you use fluticasone propionate and salmeterol inhalation powder. step 1. open your fluticasone propionate and salmeterol inhalation powder. step 2. slide the lever until you hear it click. figure b figure c follow the instructions below so you will not accidentally waste a dose: step 3. inhale your medicine. figure d figure e step 4. close the inhaler. figure f step 5. rinse your mouth. figure g when should you get a refill? the counter on top of the inhaler shows you how many doses are left. after you have taken 55 doses, the numbers 5 to 0 will show in red. see figure h. these numbers warn you there are only a few doses left and are a reminder to get a refill. figure h for correct use of the inhaler, remember: for more information about fluticasone propionate and salmeterol inhalation powder or how to use your inhaler, call hikma pharmaceuticals usa inc. at 1-800-962-8364. the brands listed are trademarks of their respective owners. this instructions for use has been approved by the u.s. food and drug administration distributed by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 c50001155/02 revised september 2022

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 and salmeterol hfa is indicated for treatment of asthma in adult and adolescent patients aged 12 years and older. fluticasone propionate and salmeterol hfa 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). limitations of use fluticasone propionate and salmeterol hfa is not indicated for the relief of acute bronchospasm. fluticasone propionate and salmeterol hfa is contraindicated in the following conditions: risk summary there are insufficient data on the use of fluticasone propionate and salmeterol hfa or individual monoproducts, fluticasone propionate and salmeterol xinafoate, in pregnant women. there are clinical considerations with the use of fluticasone propionate and salmeterol hfa in pregnant women. (see clinical considerations.) in animals, teratogenicity characteristic of cortic