One AEROBID Inhaler System is designed to deliver at least 100 metered inhalations. It is a corticosteroid that is several hundred times more potent in animal anti-inflammatory assays than the cortisol standard. Clinical studies have shown therapeutic activity on bronchial mucosa with minimal evidence of systemic activity at recommended doses. The following observations relevant to systemic absorption were made in clinical studies In one uncontrolled study a statistically significant decrease in responsiveness to metyrapone was noted in 15 adult steroid-independent patients treated with 2 A small but statistically significant drop in eosinophils from 11.

A 5% incidence of menstrual disturbances was reported during open studies, in which there were no control groups for comparison. More than 120 patients have been treated in open trials for two years or more. AEROBID inhaler is NOT indicated for the relief of acute bronchospasm. Hypersensitivity to any of the ingredients of this preparation contraindicates its use
After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery or infections, particularly gastroenteritis.

To assess the risk of adrenal insufficiency in emergency situations, routine tests of adrenal cortical function, including measurement of early morning resting cortisol levels, should be performed periodically in all patients. An early morning resting cortisol level may be accepted as normal if it falls at or near the normal mean level. Localized infections with Candida albicansor, Aspergillus nigerhave occurred in the mouth and pharynx and occasionally in the larynx.

Positive cultures for oral Candidamay be present in up to 34% of patients. Although the frequency of clinically apparent infection is considerably lower, these infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with AEROBID Inhaler. AEROBIDInhaler is not to be regarded as a bronchodilator and is not indicated for relief of bronchospasm. During such episodes, patients may require therapy with systemic corticosteroids. Transfer of patients from systemic steroid therapy to AEROBID Inhaler may unmask allergic conditions previously suppressed by the systemic steroid therapy. Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If chicken pox develops, treatment with antiviral agents may be considered.

Particular care should be taken in observing patients post-operatively or during periods of stress for evidence of a decrease in adrenal function. During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal like joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement of respiratory function. In particular, the effects resulting from chronic use of AEROBID on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown
Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.

Pulmonary infiltrates with eosinophilia may occur in patients on AEROBID Inhaler therapy. Although it is possible that in some patients this state may become manifest because of systemic steroid withdrawal when inhalational steroids are administered, a causative role for the drug and/or its vehicle cannot be ruled out. Information for Patients:Since the relief from AEROBID Inhaler depends on its regular use and on proper inhalation technique, patients must be instructed to take inhalations at regular intervals.

They should also be instructed in the correct method of use. Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles

www.healasthma.com