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warnings
WARNINGS Particular care is needed in patients who are transferred from systemically active corticosteroids to Azmacort Inhalation Aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosolized steroids in recommended doses. After withdrawal from systemic corticosteroids, a number of months is usually required for recovery of hypothalamic-pituitary-adrenal (HPA) function. For some patients who have received large doses of oral steroids for long periods of time before therapy with Azmacort Inhalation Aerosol is initiated, recovery may be delayed for one year or longer. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections, particularly gastroenteritis or other conditions with acute electrolyte loss. Although Azmacort Inhalation Aerosol may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies only normal physiological amounts of corticosteroidsystemically and does NOT provide the increased systemic steroid which is necessary for coping with these emergencies. During periods of stress or a severe asthmatic attack, patients who have been recently withdrawn from systemic corticosteroids should be instructed to resume systemic steroids (in large doses) immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. Localized infections with Candida albicans have occurred infrequently in the mouth and pharynx. These areas should be examined by the treating physician at each patient visit. The percentage of positive mouth and throat cultures for Candida albicans did not change during a year of continuous therapy. The incidence of clinically apparent infection is low (2.5%). These infections may disappear spontaneously or may require treatment with appropriate antifungal therapy or discontinuance of treatment with Azmacort Inhalation Aerosol. Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. Azmacort Inhalation Aerosol is not to be regarded as a bronchodilator and is not indicated for rapid relief of bronchospasm. As with other inhaled asthma medications, bronchospasm may occur with an immediate increase in wheezing following dosing. If bronchospasm occurs following use of Azmacort Inhalation Aerosol, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with Azmacort Inhalation Aerosol should be discontinued and alternative treatment should be instituted. Patients should be instructed to contact their physician immediately when episodes of asthma which are not responsive to bronchodilators occur during the course of treatment with Azmacort Inhalation Aerosol. During such episodes, patients may require therapy with systemic corticosteroids. The use of Azmacort Inhalation Aerosol with systemic prednisone, dosed either daily or on alternate days, could increase the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, Azmacort Inhalation Aerosol should be used with caution in patients already receiving prednisone treatment for any disease. Transfer of patients from systemic steroid therapy to Azmacort Inhalation Aerosol may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g., rhinitis, conjunctivitis, and eczema.
ADVERSE REACTIONS The table below describes the incidence of common adverse experiences based upon three placebo-controlled, multicenter US clinical trials of 507 patients (297 female and 210 male adults (age range 18-64)). These trials included asthma patients who had previously received inhaled beta 2 -agonists alone, as well as those who previously required inhaled corticosteroid therapy for the control of their asthma. The patients were treated with Azmacort Inhalation Aerosol (including doses ranging from 150 to 600 mcg twice daily for 6 weeks) or placebo. Adverse Events Occurring at an Incidence of Greater Than 3% and Greater Than Placebo Adverse Event Azmacort Dose Placebo 150 mcg bid (n=57) 300 mcg bid (n=170) 600 mcg bid (n=57) (n=167) Sinusitis 5 (9%) 7 (4%) 1 (2%) 6 (4%) Pharyngitis 4 (7%) 42 (25%) 10 (18%) 19 (11%) Headache 4 (7%) 35 (21%) 7 (12%) 24 (14%) Flu Syndrome 2 (4%) 8 (5%) 1 (2%) 5 (3%) Back Pain 2 (4%) 3 (2%) 2 (4%) 3 (2%) Adverse events that occurred at an incidence of 1-3% in the overall Azmacort Inhalation Aerosol treatment group and greater than placebo included: Body as a whole: facial edema, pain, abdominal pain, photosensitivity Digestive system: diarrhea, oral monilia, toothache, vomiting Metabolic and Nutrition: weight gain Musculoskeletal system: bursitis, myalgia, tenosynovitis Nervous system: dry mouth Organs of special sense: rash Respiratory system: chest congestion, voice alteration Urogenital system: cystitis, urinary tract infection, vaginal monilia In older controlled clinical trials of steroid dependent asthmatics, urticaria was reported rarely. Anaphylaxis was not reported in these controlled trials. Typical steroid withdrawal effects including muscle aches, joint aches, and fatigue were noted in clinical trials when patients were transferred from oral steroid therapy to Azmacort Inhalation Aerosol. Easy bruisability was also noted in these trials. Hoarseness, dry throat, irritated throat, dry mouth, facial edema, increased wheezing, and cough have been reported. These adverse effects have generally been mild and transient. Cases of oral candidiasis occurring with clinical use have been reported. (See WARNINGS . ) Cases of growth suppression have been reported for orally inhaled corticosteroids (see PRECAUTIONS, Pediatric Use section ). Post Marketing: In addition to adverse events reported from clinical trials, the following events have been identified during post approval use of Azmacort Inhalation Aerosol where these events were reported voluntarily from a population of unknown size, and the frequency of occurrence cannot be determined precisely. These include rare reports of anaphylaxis, cataracts, glaucoma and very rare reports of bone mineral density loss and osteoporosis, especially with prolonged use, which may lead to an increased risk of fractures.