Flovent Hfa

Oropharyngeal Candidiasis

• Localized Infections of the mouth and pharynx with Candida albicans has occurred in clinical trials. 

• Infections should be treated with appropriate local or systemic antifungal therapy while remaining on Flovent HFA, though Flovent HFA may need to be interrupted in some cases. 

• To reduce the risk of orpharyngeal candidiasis, patients should rinse their mouth after inhalation of Flovent HFA.

Acute Asthma Episodes

• Flovent HFA is not to be regarded as a bronchodilator and is not indicated for rapid relief of bronchospasm.

• During treatment with Flovent HFA, advise patients to contact their physician immediately if episodes of asthma that are unresponsive to bronchodilators occur. During these episodes, patients may require therapy with oral corticosteroids. 

Immunosuppression and Risk of Infections

• Patients who are using drugs that suppress the immune system are more susceptible to infections. 

• For patients who have not previously had chickenpox or measles or been vaccinated against these diseases, consider immunoglobulin prophylactic therapy if exposure occurs. Treatment with antivirals should be considered if chickenpox develops.

• Inhaled corticosteroids should be used with caution in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Transferring Patients from Systemic Corticosteroid Therapy

• HPA Suppression/Adrenal Insufficiency

• Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically-available ICS.

• Patients who have been previously maintained on 20mg 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its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.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/symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.

• In recommended doses, Flovent HFA supplies less than normal physiological amounts of corticosteroid systemically and does not provide the mineralocorticoid activity that is necessary for coping with these emergencies.

• Patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately during periods of stress or a severe asthma attack.

• Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Flovent HFA.

• Monitor lung function, beta-agonist use, and asthma symptoms during withdrawal.

• Observe patients for signs/symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea, vomiting, hypotension).

• Transfer from systemic corticosteroids may unmask allergic conditions.

• Some patients may experience systemically active steroid withdrawal, despite maintenance of improvement of respiratory function.

Hypercorticism and Adrenal Suppression 

• Monitor for hypercorticism and HPA axis suppression (if occur, reduce dose gradually).

• Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

Reduction in Bone Mineral Density

• Decreases in bone mineral density have been observed with long-term administration of ICS; patients with risk factors should be monitored and treated appropriately.

• Major risk factors for decreased bone mineral content are: prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids).

Effect on Growth

• Monitor growth in pediatric patients.

• To minimize the systemic effects, titrate each patient’s dosage to the lowest effective dose to control symptoms.

Glaucoma and Cataracts

• Glaucoma, increased intraocular pressure and cataracts have been reported following administration of inhaled corticosteroids, including fluticasone propionate. 

• Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Flovent HFA long term.

Paradoxical Bronchospasm

• Bronchospasm may occur after dosing; treat immediately with a fast-acting inhaled bronchodilator. 

• Treatment with Flovent HFA should be discontinued and alternative treatment should be started.

Eosinophilic Conditions and Churg-Strauss Syndrome

• In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with ChurgStrauss syndrome, a condition that is often treated with systemic corticosteroid therapy. 

• These events usually have been associated with the reduction and/or withdrawal of oral corticosteroid therapy after the use of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting. 

• Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established.