Budesma Warnings

Risk of adrenal insufficiency while change from systemic to inhalation therapy: It is essential to be precautious when patients are transferred from systemically active corticosteroids to inhaled Budesonide, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol Budesonide. Recovery of hypothalamic-pituitary-adrenal (HPA) function after withdrawal from systemic corticosteroids requires a number of months. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery or infections, particularly gastroenteritis. Although inhaled Budesonide may provide control of asthmatic symptoms during these episodes, it does not provide the systemic steroid which is necessary for coping with these emergencies.
During periods of stress or a severe asthmatic attack, patients, who have been withdrawn from systemic corticosteroids, should be instructed to immediately resume systemic steroids in dosages that were previously effective and to contact their physicians 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. To assess the risk of adrenal insufficiency in emergency situations, routine tests of adrenal cortical function, including measurement of early morning and evening cortisol levels, should be performed periodically in all patients. An early morning resting cortisol level may be accepted as normal only if it falls at or near the normal mean level. In the majority of patients no significant adrenal suppression occurs until doses of 1,500 μg/day, by inhalation, are exceeded. Reduction of plasma cortisol levels has been reported in some patients who received 2,000 μg/day of inhaled Budesonide. In such patients the risks of developing adrenal suppression should be balanced against the therapeutic advantages and precautions should be taken to provide systemic steroid cover in situations of prolonged stress. Prolonged suppression of the HPA axis may eventually lead to systemic effects including growth retardation in children and adolescents.
Transfer of patients from systemic steroid therapy to Budesonide may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g., rhinitis, conjunctivitis, and eczema. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids.
Studies have shown that the combined administration of alternate-day prednisone systemic treatment and orally inhaled Budesonide increases the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, Budesonide treatment should be used with caution in patients already on alternate-day prednisone regimens for any disease.
Systemic Absorption of Orally Inhaled Steroids: Because of the possibility of systemic absorption of orally inhaled corticosteroids, including Budesonide, patients should be monitored for symptoms of systemic effects such as mental disturbances, increased bruising, weight gain, cushingoid features, acneiform lesions and cataracts. If such changes occur, Budesonide should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroids.
Candidiasis: The development of pharyngeal and laryngeal candidiasis is a cause of concern because the extent of its penetration into the respiratory tract is unknown. These infections may require treatment with appropriate antifungal therapy and/or discontinuation of treatment with Budesonide, depending on the severity of the infections.
Monitoring Asthma Control: Budesonide is not to be regarded as a bronchodilator and is not indicated for rapid relief of bronchospasm. Patients will require a fast and short acting inhaled bronchodilator (e.g., salbutamol) to relieve acute asthmatic symptoms.
Patients should be instructed to contact their physicians immediately when episodes of asthma which are not responsive to bronchodilators occur during the course of treatment with Budesonide. During such episodes, patients may require therapy with systemic corticosteroids. There is no evidence that control of bronchial asthma can be achieved by the administration of Budesonide in amounts greater than the recommended dosages.