FLOVENT HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.

Not indicated for the relief of acute bronchospasm.

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

FLOVENT HFA is contraindicated in the primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.

FLOVENT HFA should be administered by the orally inhaled route only in patients aged 4 years and older. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

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

Persons who are using drugs that 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 susceptible children or adults using corticosteroids.

Transfer of patients from systemic corticosteroid therapy to FLOVENT HFA may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids.

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including fluticasone propionate.

As with other inhaled medicines, bronchospasm may occur with an immediate increase in wheezing after dosing.

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 Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy.

Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving FLOVENT HFA routinely (e.g., via stadiometry).

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects.

Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of FLOVENT HFA.

The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with FLOVENT HFA is not recommended because increased systemic corticosteroid adverse effects may occur.

There are insufficient data on the use of FLOVENT HFA in pregnant women. Animal studies: decreased fetal body weight and skeletal variations. 

There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk.

GoToSource

• Use in patients under the age of 4. GoToSource

• Acute bronchospasm. GoToSource

• Cystic fibrosis. GoToSource 

• Chronic obstructive pulmonary disease. GoToSource

• Allergic rhinitis. GoToSource

Adrenal suppression and life-threatening adrenal crisis. GoToSource

Invasive pulmonary aspergillosis (severe fungal infection). GoToSource 

Oral candidiasis (fungal infection). GoToSource 

Elevated intraocular pressure and glaucoma. GoToSource 

Osteopenia (low bone mass not as severe as osteoporosis), osteoporosis ( decreased bone density) and osteonecrosis (death of bone tissue). GoToSource

Reduction in growth velocity. GoToSource

Posterior subcapsular cataracts. GoToSource 

Churg-strauss syndrome. GoToSource

Lawsuits filed for growth suppression, infections and osteoporosis.