Asthma treatment

Information on proper use of AEROBID Inhaler System.: Do not use or store near heat or open flame. Exposure to temperatures above 120°F (49°C) may cause container to explode. Never throw container into fire or incinerator. Carcinogenesis: Long-term studies were conducted in mice and rats using oral administration to evaluate the side effects and carcinogenic potential of the drug AEROBID. There was an increase in the incidence of pulmonary adenomas in mice, but not in rats. Female rats receiving the highest oral dose had an increased incidence of mammary adenocarcinoma compared to control rats. An increased incidence of this tumor type has been reported for other corticosteroids. Reproductive performance in the low- (8 mcg/kg/day) and mid-dose (40 mcg/kg/day) groups was comparable to controls. It was also fetotoxic in these animal reproductive studies.

Nursing Mothers: It is not known whether this drug AEROBID is excreted in human milk Pediatric Use: Safety and effectiveness have not been established in children below the age of 6. Oral corticoids have been shown to cause growth suppression in children and adolescents, particularly with higher doses over extended periods.If a child or adolescent on any corticoid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer, and 122 for 2 years or longer.
Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered.

AEROBID inhaler dosage. Adults: The recommended starting dose is 2 inhalations twice daily, morning and evening, for a total daily dose of 1 mg. The maximum daily dose should not exceed 4 inhalations twice a day for a total daily dose of 2 mg. When the drug is used chronically at 2 mg/day, patients should be monitored periodically for effects on the hypothalamic-pituitary-adrenal (HPA) axis. Pediatric Patients: For children and adolescents 6-15 years of age, two inhalations may be administered twice daily for a total daily dose of 1 mg.

Insufficient information is available to warrant use in children under age 6. With chronic use, pediatric patients should be monitored for growth as well as for effects on the HPA axis. Rinsing the mouth after inhalation is advised. In patients who respond to AEROBID, improvement in pulmonary function is usually apparent within one to four weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.

Initially, AEROBID should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. A slow rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal like
joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.

Before the first use, place the AEROBID metal cartridge inside the plastic container. Shake the inhaler system before each inhalation. Before each use, remove dustcap and inspect mouthpiece for foreign objects. Hold the inhaler system upright and put plastic mouthpiece in your mouth as shown, being sure to close your lips tightly around the mouthpiece. At the same time firmly press down on the metal cartridge with your index finger. Hold your breath as long as you can. While holding your breath, stop pressing on the cartridge and remove mouthpiece from your mouth. If your doctor has prescribed two or more inhalations at each use, wait a minute to allow pressure to build up again in the metal canister, then repeat steps again. Be sure to shake the inhaler system again before each inhalation. After the prescribed number of inhalations, rinse out your mouth thoroughly with water. Clean the inhaler system every few days
To do so, remove the metal cartridge, then rinse the plastic inhaler and cap with briskly running warm water.

NOTE: If your mouth becomes sore or develops a rash, after using AEROBID inhaler be sure to mention this to your doctor, but do not stop using your inhaler system unless he tells you.
WARNING: The contents of the metal cartridge AEROBID are under pressure
Exposure to temperature above 120°F (49°C) may cause cartridge to explode
Never throw cartridge into fire or incinerator. Use by children should always be supervised by an adult.

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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

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