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.

The most common adverse events reported in clinical trials, regardless of relationship to treatment, include respiratory infection, rhinitis, coughing, and otitis media.

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.

Adrenal insufficiency may occur when transferring patients from systematic corticosteroids (see WARNING 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.