AstraZeneca
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PULMICORT RESPULES has a well-established safety profile

Demonstrated in three pivotal 3-month clinical trials with over 900 patients

  • Used worldwide for over 15 years and in the United States for over 6 years1
Demonstrated Safety

In clinical studies for PULMICRT RESPULES, there were no significant differences vs placebo in HPA*-axis function over a 12-week treatment period. Similar results were observed in three 52-week, open-label, extension studies of the pivotal trials2

  • PULMICORT RESPULES, like other inhaled corticosteroids, may impact the HPA*-axis, especially in susceptible individuals, in younger children, and in patients given high doses for prolonged periods

Generally well tolerated with adverse events comparable to placebo

  • Common adverse events vs placebo reported in clinical trials, regardless of relationship to treatment, included respiratory infection (38% vs 36%), rhinitis (12% vs 9%), coughing (9% vs 5%), otitis media (12% vs 11%), viral infection (5% vs 3%), gastroenteritis (5% vs 4%), ear infection (5% vs 4%), oral thrush/candidiasis (4% vs 2%), and espistaxis (4% vs 1%)

Inhaled corticosteroids may cause a reduction in growth velocity
The long-term effect on final adult height is unknown.

Footnote

* Hypothalamic-pituitary-adrenal.
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Learn how PULMICORT RESPULES offers flexible dosing options

Indication and Important Safety Information

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years.

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.

Common adverse events reported in clinical trials, regardless of relationship to treatment, included respiratory infection, rhinitis, coughing, otitis media, viral infection, gastroenteritis, ear infection, oral thrush/candidiasis, and epistaxis.

Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.

PULMICORT RESPULES, like other inhaled corticosteroids, may impact the hypothalamic-pituitary-adrenal axis, especially in susceptible individuals, in young children, and in patients given high doses for prolonged periods.

Particular care is needed for patients who are transferred from systemically active corticosteroids to less systemically available corticosteroids, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids (see WARNINGS in full Prescribing Information).

Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles.

[Please see accompanying full Prescribing Information (PDF).]

References

  1. Data on file, DA-RES-01.
  2. Scott MB, Skoner DP. Short-term and long-term safety of budesonide inhalation suspension in infants and young children with persistent asthma. J Allergy Clin Immunol. 1999;104:5200-5209.