Patients being treated with Azmacort Inhalation Aerosol should receive the following information and instructions.
This information is intended to aid them in the safe and effective use of this medication. It is not a complete
disclosure of all possible adverse or intended effects.
Patients should use Azmacort Inhalation Aerosol at regular intervals as directed. Results of clinical trials
indicate that significant improvement in asthma may occur by 1 week, but maximum benefit may not be achieved for 2
weeks or more. The patient should not increase the prescribed dosage but should contact the physician if symptoms do
not improve or if the condition worsens.
In clinical studies and post-marketing experience with Azmacort Inhalation Aerosol, local infections of the
oropharynx with Candida albicans have occurred. When such an infection develops, it should be treated with
appropriate local or systemic (i.e., oral antifungal) therapy while remaining on treatment with Azmacort
Inhalation Aerosol. However, at times therapy with Azmacort Inhalation Aerosol may need to be interrupted.
Patients should be instructed to track their use of Azmacort Inhalation Aerosol and to dispose of the canister
after 240 actuations since reliable dose delivery cannot be assured after 240 doses.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or
measles and if exposed, to obtain medical advice.