Well-Established Safety Profile

PULMICORT RESPULES has a well-established safety profile

PULMICORT RESPULES is the only branded FDA-approved inhaled corticosteroid (ICS) for the treatment of asthma in children from 12 months to 4 years of age.

The incidence and nature of adverse events were comparable to those reported for placebo.²³ 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 epistaxis (4% vs 1%).²³

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Indication

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.

Important Safety Information

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.

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.

Please see accompanying full Prescribing Information (PDF).

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