When it is time
for an inhaled corticosteroid (ICS), consider:
  • The safety profile of budesonide 1-4
  • Proven asthma control *5

*Asthma control is defined by the measure of lung function in both adult and pediatric clinical trials for PULMICORT FLEXHALER. The primary end point in the adult pivotal trial was mean change from baseline in FEV1 (forced expiratory volume in 1 second). In the pediatric pivotal trial, the primary end point was change in % predicted FEV1.

References

  1. Agertoft L, Pedersen S. Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med. 2000;343:1064-1069.
  2. Agertoft L, Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med. 1994;88;373-381.
  3. Data on file, DA-PTH-04.
  4. Tinkelman DG, Bronsky EA, Gross G, Schoenwetter WF, Spector SL. Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma. 2003;40:225-236.
  5. Data on file, DA-PFH-06.

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

  • 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 (see WARNINGS in full Prescribing Information)

  • 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

  • Common adverse events reported in clinical trials, regardless of relationship to treatment, include nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, and viral upper respiratory tract infection

Please click here for full Prescribing Information for PULMICORT FLEXHALER.

This product information is intended for US health care professionals only.