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Rhinocort Aqua

[Budesonide]


Warnings & Precautions
WARNINGS

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of corticosteroid withdrawal, eg, joint and/ or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and trans-ferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic cortico-steroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on immunosuppressant doses of corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

Text Continues Below



How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/ or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophy-laxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered.

PRECAUTIONS

General

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS, Pediatric Use). Rarely, immediate and/ or delayed hypersensitivity reactions may occur after the intranasal administration of budesonide. Rare instances of wheezing, nasal septum perforation, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including budesonide. Although systemic effects have been minimal with recommended doses of RHINOCORT AQUA Nasal Spray, any such effect is dose dependent.

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