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).]
This product information is intended for US Health Care professionals only.
PULMICORT RESPULES is a registered trademark and ASTHMAKIDCARE and EVERYDAYKIDZ
are trademarks of the AstraZeneca group of companies.
. All rights reserved.
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