IMPORTANT INFORMATION ABOUT PULMICORT FLEXHALER

Important Safety Information

• PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm
• Particular care is needed for patients who are transferred from systemically active corticosteroids to PULMICORT FLEXHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
• Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles
• It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses
• Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown
• Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids
• Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide
• PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur
• Adverse reactions that occurred at a rate of ≥1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis

Indication

• PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older

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* Inhaled corticosteroid.

^† Asthma control was measured by lung function improvements in both adult and pediatric patients in clinical trials for PULMICORT FLEXHALER. The primary endpoint in the adult pivotal trial was mean change from baseline in forced expiratory volume in 1 second (FEV₁). In the pediatric pivotal trial, the primary endpoint was change in % predicted FEV₁. Additional measures of control (secondary efficacy endpoints) included morning and evening peak expiratory flow (PEF) (in both adults and children) and daytime and nighttime asthma symptom severity and rescue medication use (in adults).