IMPORTANT SAFETY INFORMATION ABOUT PULMICORT RESPULES

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

Particular care is needed for patients who are transferred from systemically active corticosteroids to PULMICORT RESPULES, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses.

Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles.

Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.

Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide.

As with other inhaled medications, paradoxical bronchospasm may occur with PULMICORT RESPULES.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions and clinical features consistent with Churg-Strauss Syndrome.

Adverse reactions that occurred at a rate of ≥ 3% are: respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, and rash.

Indication

PULMICORT RESPULES (budesonide inhalation suspension) is indicated for the maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years.

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