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

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AEROSPAN
TM
(flunisolide HFA, 80 mcg) 
Inhalation Aerosol 
For Oral Inhalation Only 
Rx Only 
DESCRIPTION 
Flunisolide hemihydrate, the active component of AEROSPAN
TM
(flunisolide HFA, 80 
mcg) Inhalation Aerosol, is a corticosteroid having the chemical name 6
α
-Fluoro-11
β
, 
16
α
, 17, 21 –tetrahydroxylpregna-1, 4-diene-3, 20-dione cyclic-16, 17-acetal with 
acetone, hemihydrate and the following chemical structure: 
O
O
O
F
C
CH
3
CH
3
HO
HO
O
Flunisolide Hemihydrate
H
2
O
1/2
.
Flunisolide hemihydrate is a white to creamy white crystalline powder with a molecular 
weight of 443.51 and an empirical formula of C
24
H
31
O
6
F
•
½ H
2
O. It is soluble in 
acetone, ethyl alcohol and HFA-134a and practically insoluble in water.
AEROSPAN Inhalation Aerosol is a pressurized, metered-dose inhaler unit intended for 
oral inhalation only. The inhaler unit consists of a metal canister, a purple actuator, and a 
gray spacer. Each unit contains a 0.24 % w/w solution of flunisolide hemihydrate in 
10:90 w/w ethanol:1,1,1,2-tetrafluoroethane (HFA 134a). After priming, each actuation 
delivers 139 mcg of flunisolide hemihydrate in 58 mg of solution from the canister valve 
and 80 mcg of flunisolide hemihydrate (equivalent to 78 mcg flunisolide) from the spacer 
at a flow rate of 30 L/min for 4 seconds.
Using an 
in-vitro 
method at a fixed volume of 2 L, each actuation at the beginning of 
canister content delivers from the spacer 76 mcg (95% of the label claim) at a flow rate of 
30 L/min, 61 mcg (76% of the label claim) at a flow rate of 20 L/min, 85 mcg (106% of 
the label claim) at a flow rate of 40 L/min, and 96 mcg (120% of the label claim) at a 
flow rate of 60 L/min. The actual amount of drug delivered to the lung may depend upon 
patient factors, such as timing and coordination between the actuation and inspiration and 
the strength and duration of the inspiration. Data show that both the one- and two-

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2
actuation doses are depleted by 75% or more after waiting one second between actuation 
and inhalation. 
The 5.1-g net weight canister provides 60 metered actuations and the 8.9-g net weight 
canister provides 120 metered actuations.
AEROSPAN Inhalation Aerosol should be primed before using for the first time by 
releasing 2 test sprays into the air away from the face. In cases where the inhaler has not 
been used for more than 2 weeks, the inhaler should be primed again by releasing 2 test 
sprays into the air away from the face. 
This product does not contain chlorofluorocarbon (CFC).