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PULMICORT REPULES is delivered right to the lungs by simply breathing through a nebulizer2

Nebulizer delivery is less dependent on patient coordination or cooperation. By simply breathing through a nebulizer, patients get PULMICORT RESPULES right to the lungs. The National Institutes of Health (NIH) recognizes the nebulizer as an effective delivery method for infants and young children.1

PULMICORT RESPULES is the first corticosteroid to be approved for use in a nebulizer for pediatric patients and is the only FDA-approved nebulized ICS for kids 12 months to 8 years of age for the maintenance treatment of asthma and as a prophylactic therapy.

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

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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 (PDF).]

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; p.18.