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

 
14
ADVERSE EVENTS FROM OTHER SOURCES 
 
Two 52-week open label safety studies of AEROSPAN Inhalation Aerosol were 
conducted in 162 asthma patients 12 to 60 years of age and in 152 asthma patients 4 to 11 
years of age. The adverse event profile exhibited in these studies was similar to that seen 
in the two 12-week studies. 
 
The following additional adverse events were derived from clinical studies conducted 
with flunisolide CFC inhalation aerosol with a frequency of 
≥
1% and not described 
above:
Body as a Whole: flu, decreased appetite, chills, increased appetite, weight gain, malaise, 
peripheral edema, sweating, weakness 
Gastrointestinal System: upset stomach, heartburn, constipation, gas, abdominal fullness 
Cardiovascular System: palpitations, hypertension, tachycardia 
Nervous System: headache, irritability, shakiness, anxiety, depression, faintness, fatigue, 
hyperactivity, hypoactivity, moodiness, numbness, vertigo,
Respiratory System: cold symptoms, nasal congestion, upper respiratory tract infection, 
chest congestion, hoarseness, runny nose, sinus congestion, sinus drainage, sinus 
infection, sneezing, sputum, wheezing, chest tightness, bronchospasm, dyspnea, head 
stuffiness, nasal irritation, pleurisy, pneumonia, sinus discomfort 
Skin and Appendages: eczema, pruritus, acne, urticaria 
Special Senses: loss of smell, loss of taste, ear infection, blurred vision, eye discomfort, 
eye infection 
Hemic and Lymph: capillary fragility, enlarged lymph nodes 
Mouth and Throat: sore throat, dry throat, glossitis, mouth irritation, phlegm, throat 
irritation 
OVERDOSAGE 
Flunisolide hemihydrate infused intravenously at doses up to 4000 mcg/kg in mice, rats 
and dogs (approximately 25, 50 and 170 times, respectively, the maximum recommended 
daily inhalation dose in adults and approximately 30, 60 and 200 times, respectively, the 
maximum recommended daily inhalation dose in children on a mg/m
2
basis) produced no 
mortality. 
In a double-blind, placebo-controlled study, 18 mg of flunisolide hemihydrate was 
administered via the CFC formulation over a three-hour period (nine times the maximum 
labeled daily dose) in 94 patients with acute asthma, and no clinically deleterious effects 
were observed.