PULMICORT FLEXHALER

Budesonide DPI* – an active ingredient with long-term safety data

In the CAMP study, a long-term, large, controlled US study of treatments for childhood asthma2...

[Ref 2: Childhood Asthma Management Program Research Group, Table 3 on p. 1058] [Ref 3: National Heart, Lung, and Blood Institute, paragraph 2]

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™.


Indications and Important Safety Information for PULMICORT TURBUHALER

  • PULMICORT TURBUHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older
  • PULMICORT TURBUHALER 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 TURBUHALER 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 respiratory infection, headache, oral candidiasis, pharyngitis, voice alteration, and sinusitis

    • Please click here for full Prescribing Information for PULMICORT TURBUHALER.