PULMICORT FLEXHALER

Efficacy that addresses many asthma control parameters

Differences from baseline favoring PULMICORT FLEXHALER™ over placebo*†

[Ref 3: Prescribing Information, (P.I.) lines 279-348] efficacy adult clinical chart
  • A multicenter, placebo-controlled, 12-week trial of adults 18 to 80 years of age with mild-to-moderate asthma whose symptoms were previously controlled on inhaled corticosteroids [Ref 3: Prescribing Information, (P.I.) lines 306-309]
  • In adult patients, mean change from baseline in FEV1, the primary efficacy endpoint in this study, was statistically significant vs placebo (P < .001) over 12 weeks*[Ref 4: Prescribing Information, (P.I.) lines 309-313]
  • The responses of PULMICORT FLEXHALER™ compared with PULMICORT TURBUHALER®(budesonide inhalation powder) tended to be lower
efficacy pediatric clinical chart
  • A multicenter, placebo-controlled, 12-week trial of children 6 to 17 years of age with mild asthma who were treated with inhaled corticosteroids no more than 30 days before the study began (4%) and who were naive to inhaled corticosteroids (96%)3 [Ref 3: Prescribing Information, (P.I.) lines 330-335]
  • In pediatric patients, mean change from baseline in % predicted FEV1, the primary efficacy endpoint in this study, was statistically significant vs placebo (P < .001) over 12 weeks†3 [Ref 3: Prescribing Information, (P.I.) lines 335-339]

*In a multicenter, placebo-controlled, 12-week trial of adults 18 to 80 years of age with mild-to-moderate asthma whose symptoms were previously controlled on inhaled corticosteroids. The dosage used in this study was 180 mcg, 2 inhalations, bid.

†In a multicenter, placebo-controlled, 12-week trial of children 6 to 17 years of age with mild asthma who were treated with inhaled corticosteroids no more than 30 days before the study began (4%) and who were naive to inhaled corticosteroids (96%). The dosage used in this study was 90 mcg, 4 inhalations, bid.4 [Ref 4: Prescribing Information, (P.I.) lines 306-309]

‡ Forced expiratory volume in 1 second.

§ Peak expiratory flow.

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.