Aerospan tm (flunisolide hfa, 80 mcg) Inhalation Aerosol For Oral Inhalation Only Rx Only description

 
 
Carcinogenesis, Mutagenesis, Impairment of Fertility: 
In a 22 month study in Swiss 
mice, flunisolide hemihydrate at oral doses up to 500 mcg/kg/day (approximately 3 and 4 
times the maximum recommended daily inhalation dose in adults and children on a 
mg/m
2
basis) did not demonstrate any carcinogenic effects. 
In a two year study in Sprague Dawley rats, administration of flunisolide hemihydrate in 
the diet at a dose of 2.5 mcg/kg/day (less than the maximum recommended daily 
inhalation dose in adults or children on a mg/m
2
basis) resulted in an increased incidence 
of mammary gland adenomas and islet cell adenomas of the pancreas in females. The 
significance of these findings for humans is unknown. There were no significant 
increases in the incidence of any tumor type in female rats at a dose of 1.0 mcg/kg/day 
(less than the maximum recommended daily inhalation dose in adults or children on a 
mg/m
2
basis), or in male rats at a dose of 2.5 mcg/kg/day (less than the maximum 
recommended daily inhalation dose in adults or children on a mg/m
2
basis).
Flunisolide hemihydrate showed no mutagenic activity when tested in 
in vitro
bacterial 
assay systems (Ames Assay and the Rec-assay) and no clastogenic activity when tested in 
the 
in vitro
chromosomal aberration assay using Chinese Hamster CHL cells and in the 
in 
vivo
mouse bone marrow chromosomal aberration assay. 
Studies on the effects of flunisolide hemihydrate on fertility in female rats showed that 
flunisolide hemihydrate, at an oral dose of 200 mcg/kg/day (approximately 3 times the 
maximum recommended daily inhalation dose on a mg/m
2
basis) impaired fertility, but 
was devoid of such effects at doses up to 40 mcg/kg/day (less than the maximum 
recommended daily inhalation dose on a mg/m
2
basis).