AstraZeneca

PULMICORT RESPULES is the only ICS approved for children younger than 4 years of age

PULMICORT RESPULES is an inhaled corticosteroid (ICS). The NIH* recommends ICSs as preferred treatment of persistent asthma in young children.1

The National Asthma Education and Prevention Program (NAEPP) guidelines, initiated by the NIH through the NHLBI, state that inhaled corticosteroids are the preferred treatment to maintain long-term control among patients with persistent asthma.

PULMICORT RESPULES is developed and approved specifically for children 12 months to 8 years of age to prevent asthma symptoms and attacks. PULMICORT RESPULES is not indicated for the relief of acute bronchospasm.

Numerous placebo-controlled clinical trials in over 900 patients as young as 12 months of age demonstrate the safety and efficacy of PULMICORT RESPULES.

  • In a study of more than 340 children, once daily PULMICORT RESPULES:
    • Significantly decreased daytime asthma symptoms2
    • Significantly decreased nightime asthma symptoms2 More...
  • Among ICS-dependent children, PULMICORT RESPULES decreased breakthrough medication use and improved lung function.3 More...
  • In a placebo-controlled study of 469 children, PULMICORT RESPULES significantly reduced reliance on short-acting ß2-agonists4 and significantly improved morning peak expiratory flow compared to placebo.5 More...

Footnotes

* NIH—National Institutes of Health
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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.]

References

  1. National Heart, Lung, and Blood Institute. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma—Update on Selected Topics 2002. Bethesda, MD: National Institutes of Health; June 2003. NIH Publication 02-5074.
  2. Kemp JP, Skoner DP, Szefler SJ, et al. Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children. Ann Allergy Asthma Immunol. 1999;83:231-239.
  3. Shapiro G, Mendelson L, Kraemer MJ, et al. Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma. J Allergy Clin Immunol. 1998:102:789-796.
  4. Baker JW, Mellon M, Wald J, et al. A multiple-dosing, placebo-controlled study of budesonide inhalation suspension given once or twice daily for treatment of persistent asthma in young children and infants. Pediatrics. 1999;103:414-421.
  5. Leflein JG, Szefler SJ, Murphy KR, et al. Nebulized budesonide inhalation suspension compared with cromolyn sodium nebulizer solution for asthma in young children: results of a randomized outcomes trial. Pediatrics. 2002; 109:866-872.