Proven effective in adults for the control of mild persistent asthma

PULMICORT FLEXHALER significantly reduced albuterol use and asthma symptoms
and improved peak expiratory flow (PEF)* in adult patients1

PULMICORT FLEXHALER showed improved asthma control was achieved within as little as 24 hours

  • Improvement in mean change from baseline in FEV1, the primary efficacy end point in this study, was statistically significant vs placebo over 12 weeks (P<.001)

  • PULMICORT FLEXHALER significantly reduced albuterol use in adult patients1

  • Additional secondary end points of morning and evening PEF† and daytime and nighttime asthma symptom severity showed differences from baseline, favoring PULMICORT FLEXHALER over placebo

  • PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm

References

  1. 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.