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ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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Endocrine And Metabolism<br />

Systemic Steroid Replacement by Inhaled Steroid<br />

Particular care is needed in patients who are transferred from systemically active<br />

corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have<br />

occurred in patients with asthma during and after transfer. For the transfer of patients<br />

being treated with oral corticosteroids, inhaled corticosteroids should first be added to the<br />

existing oral steroid therapy which is then gradually withdrawn.<br />

Patients with adrenocortical suppression should be monitored regularly and the oral<br />

steroid reduced cautiously. Some patients transferred from other inhaled steroids or oral<br />

steroids remain at risk of impaired adrenal reserve for a considerable time after<br />

transferring to inhaled fluticasone propionate.<br />

After withdrawal from systemic corticosteroids, a number of months are required for<br />

recovery of hypothalamic-pituitary-adrenal (HPA) function. During this period of HPA<br />

suppression, patients may exhibit signs and symptoms of adrenal insufficiency when<br />

exposed to trauma, surgery or infections, particularly gastroenteritis. Although inhaled<br />

fluticasone propionate may provide control of asthmatic symptoms during these episodes,<br />

it does not provide the systemic steroid which is necessary for coping with these<br />

emergencies. The physician may consider supplying oral steroids for use in times of<br />

stress (e.g. worsening asthma attacks, chest infections, and surgery).<br />

During periods of stress or a severe asthmatic attack, patients who have been withdrawn<br />

from systemic corticosteroids should be instructed to resume systemic steroids<br />

immediately and to contact their physician for further instruction. These patients should<br />

also be instructed to carry a warning card indicating that they may need supplementary<br />

systemic steroids during periods of stress or a severe asthma attack. To assess the risk of<br />

adrenal insufficiency in emergency situations, routine tests of adrenal cortical function,<br />

including measurement of early morning and evening cortisol levels, should be<br />

performed periodically in all patients. An early morning resting cortisol level may be<br />

accepted as normal only if it falls at or near the normal mean level.<br />

Systemic Effects<br />

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses<br />

prescribed for long periods; these effects are much less likely to occur than with oral<br />

corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid<br />

features, and adrenal suppression, growth retardation in children and adolescents,<br />

decrease in bone mineral density (BMD), cataract and glaucoma. It is important<br />

therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which<br />

effective control is maintained (see Monitoring and Laboratory Tests).<br />

Effects on Growth<br />

A reduction of growth velocity in children or teenagers may occur as a result of<br />

inadequate control of chronic diseases such as asthma or from use of corticosteroids for<br />

treatment. Physicians should closely follow the growth of children and adolescents<br />

July 29, 2014<br />

Page 7 of 67

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