warnings and cautions
5 WARNINGS AND PRECAUTIONS Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation. (5.1) Deterioration of asthma and acute episodes: Do not use beclomethasone dipropionate HFA inhalation aerosol for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to beclomethasone dipropionate HFA inhalation aerosol. (5.3) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. (5.4) Paradoxical Bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat bronchospasm immediately with inhaled, short-acting bronchodilator and discontinue beclomethasone dipropionate HFA inhalation aerosol. (5.5) Hypersensitivity Reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur. Discontinue beclomethasone dipropionate HFA inhalation aerosol if such reactions occur. (5.6) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue beclomethasone dipropionate HFA inhalation aerosol slowly. (5.7) Effects on growth: Monitor growth of pediatric patients. (5.8) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content. (5.9) Eye Disorders: Monitor patients with change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts closely. (5.10) 5.1 Local Effects Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving beclomethasone dipropionate HFA inhalation aerosol. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with beclomethasone dipropionate HFA inhalation aerosol therapy, but at times therapy with beclomethasone dipropionate HFA inhalation aerosol may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised. 5.2 Deterioration of Asthma and Acute Episodes Beclomethasone dipropionate HFA inhalation aerosol is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta-2 agonist, not beclomethasone dipropionate HFA inhalation aerosol, should be used to relieve acute symptoms such as shortness of breath. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with beclomethasone dipropionate HFA inhalation aerosol. During such episodes, patients may require therapy with oral corticosteroids. 5.3 Transferring Patients from Systemic Corticosteroid Therapy Particular care is needed in patients who are transferred from systemically active corticosteroids to beclomethasone dipropionate HFA inhalation aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. 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 severe electrolyte loss. Although beclomethasone dipropionate HFA inhalation aerosol may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid that 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 resume oral corticosteroids (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. Patients requiring oral or other systemic corticosteroids should be weaned slowly from oral or other systemic corticosteroid use after transferring to beclomethasone dipropionate HFA inhalation aerosol. Lung function (FEV 1 or PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral or other systemic corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. Transfer of patients from systemic corticosteroid therapy to beclomethasone dipropionate HFA inhalation aerosol may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions. During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. 5.4 Immunosuppression Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox 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 or been properly immunized, particular care should be taken to avoid exposure. It is not known how the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection. Nor is the contribution of the underlying disease and/or prior corticosteroid treatment known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. 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. 5.5 Paradoxical Bronchospasm Inhaled corticosteroids may produce inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. If inhalation induced bronchospasm occurs following dosing with beclomethasone dipropionate HFA inhalation aerosol, it should be treated immediately with an inhaled, short-acting bronchodilator. Treatment with beclomethasone dipropionate HFA inhalation aerosol should be discontinued and alternate therapy instituted. 5.6 Immediate Hypersensitivity Reactions Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur after administration of beclomethasone dipropionate HFA inhalation aerosol. Discontinue beclomethasone dipropionate HFA inhalation aerosol if such reactions occur [see Contraindications (4.2) ] . 5.7 Hypercorticism and Adrenal Suppression Beclomethasone dipropionate HFA inhalation aerosol will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since beclomethasone dipropionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of beclomethasone dipropionate HFA inhalation aerosol in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with beclomethasone dipropionate HFA inhalation aerosol should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when beclomethasone dipropionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of beclomethasone dipropionate HFA inhalation aerosol should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms. 5.8 Effects on Growth Orally inhaled corticosteroids, including beclomethasone dipropionate HFA inhalation aerosol, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving beclomethasone dipropionate HFA inhalation aerosol routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including beclomethasone dipropionate HFA inhalation aerosol, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4) ] . 5.9 Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids) should be monitored and treated with established standards of care. 5.10 Eye Disorders Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of long-term administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma and/or cataracts while using beclomethasone dipropionate HFA inhalation aerosol.