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

prasco laboratories - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. important limitations of use: ciclesonide inhalation aerosol is not indicated for the relief of acute bronchospasm. ciclesonide inhalation aerosol is not indicated for children under 12 years of age. ciclesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ciclesonide inhalation aerosol is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of ciclesonide inhalation aerosol. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 50 ug - omnaris nasal spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. omnaris nasal spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. omnaris nasal spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of omnaris nasal spray [see warnings and precautions (5.3)] . teratogenic effects : pregnancy category c. there are no adequate and well-controlled studies in pregnant women. omnaris nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. in addition, because there is a natural increase in corticosteroid p

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 80 ug - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. important limitations of use: alvesco is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. alvesco is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of alvesco. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose based on mcg/m2 /day) produced no teratogenicity or other fetal effects. however, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg/day (less than the maximum human daily inhalation dose based on mcg/m2 /day) or greater produced fetal toxicity. th

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 37 ug - zetonna® (ciclesonide) nasal aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. zetonna is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of zetonna [see warnings and precautions (5.3) ]. teratogenic effects : pregnancy category c. there are no adequate and well-controlled trials in pregnant women. zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. oral administration of ciclesonide in rats at approximately 120 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal

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

covis pharma us, inc - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 80 ug - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. limitations of use : alvesco is not indicated for the relief of acute bronchospasm. alvesco is not indicated for children under 12 years of age. alvesco is contraindicated in: there are no available data on alvesco use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is low systemic exposure following alvesco oral inhalation administration at the recommended dose [see clinical pharmacology (12.3)] . in animal reproduction studies, ciclesonide administered by the oral route to pregnant rats during the period of organogenesis did not cause any evidence of fetal harm at doses up to 15 times the maximum recommended human daily oral inhalation dose (mrhdoid) of 640 mcg/day. teratogenicity, characteristic of corticosteroids, decreased body weight and/or skeletal variations were observed in

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

physicians total care, inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 50 ug - omnaris nasal spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. omnaris nasal spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. omnaris nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

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

physicians total care, inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 80 ug - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. alvesco is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. alvesco is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of alvesco. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose based on mcg/m2 /day) produced no teratogenicity or other fetal effects. however, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg/day (less than the maximum human daily inhalation dose based on mcg/m2 /day) or greater produced fetal toxicity. this included fetal loss, reduc

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

covis pharma us, inc - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - omnaris nasal spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. omnaris nasal spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. omnaris nasal spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of omnaris nasal spray [see warnings and precautions (5.3)] . there are no data on onmaris nasal spray use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is low systemic exposure following omnaris nasal spray administration at the recommended dose [see clinical pharmacology (12.3)] . in animal reproduction studies, ciclesonide, administered by the oral route to pregnant rats, during the period of organogenesis, did not cause any evidence of fetal harm at doses up 45 times the maximum

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

covis pharma us, inc - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - zetonna® (ciclesonide) is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. zetonna® (ciclesonide) is indicated for the treatment of symptoms associated with perennial allergic rhinitis in adult and pediatric patients 12 years of age and older. zetonna is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of zetonna [see warnings and precautions (5.3)] . there are no available data on zetonna use in pregnant women to assess a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is low systemic exposure following zetonna administration at the recommended dose [see clinical pharmacology (12.3)] . in animal reproduction studies, ciclesonide, administered by the oral route to pregnant rats, during the period of organogenesis, did not cause any evidence of fetal harm at doses up to 120 times the maximum recommended human dai

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

sixarp, llc - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. limitations of use : alvesco is not indicated for the relief of acute bronchospasm. alvesco is not indicated for children under 12 years of age. alvesco is contraindicated in: - the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - patients with known hypersensitivity to ciclesonide or any of the ingredients of alvesco. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. there are no available data on alvesco use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is low systemic exposure following alvesco oral inhalation administration at the recommended dose [see clinical pharmacology ( 12.3)] . in animal reproduction studies, ciclesonide administered by the oral route to pregnant rats during the period of organogenesis did not cause any evidence of fetal harm at doses up to 15 times the maximum recommended human daily oral inhalation dose (mrhdoid) of 640 mcg/day. teratogenicity, characteristic of corticosteroids, decreased body weight and/or skeletal variations were observed in rabbit fetuses following administration of ciclesonide to pregnant rabbits by the subcutaneous route during the period of organogenesis at doses 0.15 times the mrhdoid and higher on a mcg/m 2 basis (see data). no evidence of fetal harm was observed in rabbits at doses of 0.03 times the mrhdoid. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the united states 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. disease-associated maternal and/or embryo/fetal 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 with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. animal data in an embryo-fetal development study in pregnant rats dosed by the oral route during the period of organogenesis from gestation days 6 to 15, ciclesonide did not cause any evidence of fetal harm at doses up to approximately 15 times the mrhdoid in adults (on a mcg/m 2 basis with maternal oral dose up to 900 mcg/kg/day). maternal toxicity, as evidenced by decreased body weight gain, was observed at approximately 15 times the mrhdoid in adults (on a mcg/m 2 basis at a maternal dose of 900 mcg/kg/day); however, no adverse effects were observed at doses 5 times the mrhdoid and lower (on a mcg/m 2 basis with maternal oral doses of 300 mcg/kg/day and lower). in two embryo-fetal development studies in pregnant rabbits dosed by the subcutaneous route during the period of organogenesis from gestation days 6 to 18, ciclesonide caused acampsia (flexures of legs) in fetuses at doses 0.15 times the mrhdoid and higher (on a mcg/m 2 basis with maternal oral doses of 5 mcg/kg/day and higher), decreased body weight, cleft palate, enlarged fontanelle, parchment-like skin, and incomplete ossification of bones in fetuses at doses 0.76 times the mrhdoid (on a mcg/m 2 basis with a maternal subcutaneous dose of 25 mcg/kg/day), and embryo-fetal death at doses 3 times the mrhdoid and higher (on a mcg/m 2 basis with maternal subcutaneous doses of 100 mcg/kg/day and higher). no evidence of fetal harm was observed at a dose 0.03 times the mrhdoid in adults (on a mcg/m 2 basis at a maternal subcutaneous dose of 1 mcg/kg/day). maternal toxicity was observed at doses 3 times the mrhdoid in adults (on a mcg/m 2 basis with maternal subcutaneous doses of 100 mcg/kg/day and lower); however, no evidence of toxicity was observed at doses 0.76 times the mrhdoid and lower (on a mcg/m 2 basis with maternal subcutaneous doses of 25 mcg/kg/day and lower). in a prenatal and postnatal development study in pregnant rats dosed by the oral route from gestation day 6 to lactation day 20, ciclesonide produced no adverse developmental effects on offspring at doses up to approximately 15 times the mrhdoid (on a mcg/m 2 basis at maternal oral doses up to 900 mcg/kg/day). there are no data on the presence of ciclesonide or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. it is not known whether oral inhalation administration of ciclesonide at the recommended dose could result in sufficient systemic absorption to produce detectable quantities in human milk [see clinical pharmacology ( 12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for alvesco, and any potential adverse effects on the breastfed infant from alvesco, or from the underlying maternal condition. the molecular weight of the prodrug ciclesonide (approximately 541 g/mol) is small enough to be excreted into breast milk; however, its high plasma protein binding affinity and very short half-life suggests that minimal amounts will be present within the milk. conversely, the half-life of the active metabolite des-ciclesonide (approximately 471 g/mol) suggests that exposure to the nursing infant will be greater than that of the prodrug ciclesonide. although ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1% for each) due to low gastrointestinal absorption and high first-pass metabolism, the relative anti‑inflammatory activity of des-ciclesonide is 120 times greater than that of the ciclesonide and 12 times greater than that of dexamethasone [see clinical pharmacology ( 12.1)] . the effects of this exposure on a nursing infant are unknown, however, like all corticosteroids, suppression of the hpa function is a potential complication. animal data a study with 14 c-ciclesonide showed milk exposure of rat pups to 0.006% of the dose secreted in milk. the safety and effectiveness of alvesco for the maintenance treatment of asthma as prophylactic therapy have been established in pediatric patients aged 12 years and older. use of alvesco for this indication is supported by evidence from randomized, double-blind, placebo-controlled, parallel-group clinical trials in adult and pediatric patients 12 years of age and older with mild persistent to severe persistent asthma [see clinical studies ( 14)] . the safety and effectiveness of alvesco have not been established in pediatric patients younger than 12 years of age. pediatric patients 4 to 11 years of age effectiveness was not demonstrated in two randomized, double-blind, placebo-controlled studies that were conducted to evaluate the efficacy of alvesco 40, 80, or 160 mcg administered once daily for 12 weeks in patients 4 to 11 years of age with asthma. these studies included 1018 patients previously using either controller therapy (predominately inhaled corticosteroids) or reliever therapy (bronchodilator therapy alone). the patients had a mean baseline percent predicted fev 1 of 68%. the primary efficacy endpoint was morning pre-dose fev 1 . other measures of efficacy included am pef, asthma symptoms, and rescue albuterol use. the studies showed inconsistent results and did not establish the efficacy of alvesco in patients 4 to 11 years of age. pediatric patients 2 to 6 years of age effectiveness was not demonstrated in one randomized, double-blind, placebo-controlled study that was conducted to evaluate the efficacy of alvesco 40, 80, and 160 mcg administered once daily for 24 weeks in 992 patients 2 to 6 years of age with persistent asthma. the primary efficacy endpoint was time to the first severe asthma exacerbation [defined as worsening of asthma which required treatment with systemic (including oral) steroids or any other asthma medication besides treatment medication and rescue medication] or lack of improvement, whichever occurred first. no statistically significant differences were observed for the individual comparisons of alvesco 40, 80, and 160 mcg to placebo. results from this study did not establish efficacy of alvesco in patients 2 to 6 years of age. studies in children under 2 years of age have not been conducted given the lack of efficacy observed in patients 2 to 11 years of age. effect on growth controlled clinical studies have shown that orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. in these studies, the mean reduction in growth velocity was approximately one centimeter per year (range 0.3 to 1.8 cm per year) and appears to be related to dose and duration of exposure. this effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. the potential for "catch up" growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. the growth of pediatric patients receiving orally inhaled corticosteroids, including alvesco, should be monitored routinely (e.g., via stadiometry). a 52-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study was conducted to assess the effect of orally inhaled ciclesonide on growth rate in 609 pediatric patients with mild persistent asthma, aged 5 to 8.5 years. treatment groups included orally inhaled ciclesonide 40 mcg or 160 mcg or placebo given once daily. growth was measured by stadiometer height during the baseline, treatment and follow-up periods. the primary comparison was the difference in growth rates between ciclesonide 40 mcg and 160 mcg and placebo groups. conclusions cannot be drawn from this study because compliance could not be assured. there was no difference in efficacy measures between the placebo and the alvesco groups. ciclesonide blood levels were also not measured during the one-year treatment period. the potential growth effects of prolonged treatment with orally inhaled corticosteroids should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. to minimize the systemic effects of orally inhaled corticosteroids, including alvesco, each patient should be titrated to his/her lowest effective dose. clinical studies of alvesco did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.