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warnings
WARNINGS The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticoids 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 corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms. Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. The use of Nasacort Nasal Inhaler with alternate-day systemic prednisone could increase the likelihood of hypothalamic-pituitary-adrenal (HPA) suppression compared to a therapeutic dose of either one alone. Therefore, Nasacort Nasal Inhaler should be used with caution in patients already receiving alternate-day prednisone treatment for any disease.
ADVERSE REACTIONS Adults and Children 12 years of age and older In controlled and uncontrolled studies, 1257 adult and adolescent patients received treatment with intranasal triamcinolone acetonide. Adverse reactions are based on the 567 patients who received a product similar to the marketed Nasacort canister. These patients were treated for an average of 48 days (range 1 to 117 days). The 145 patients enrolled in uncontrolled studies received treatment from 1 to 820 days (average 332 days). The most prevalent adverse experience was headache, being reported by approximately 18% of the patients who received Nasacort . Nasal irritation was reported by 2.8% of the patients receiving Nasacort . Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received Nasacort and included: dry mucous membranes, naso-sinus congestion, throat discomfort, sneezing, and epistaxis. The complaints do not usually interfere with treatment and in the controlled and uncontrolled studies approximately 1% of patients have discontinued because of these nasal adverse effects. In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely (see OVERDOSAGE section). Children 6 through 11 years of age Adverse event data in children 6 through 11 years of age are derived from two controlled clinical trials of two and four weeks duration. In these trials, 127 patients received fixed doses of 220 mcg/day of triamcinolone acetonide for an average of 22 days (range 8 to 33 days). Adverse events occurring at an incidence of 3% or greater and more common among children treated with 220 mcg triamcinolone acetonide daily than vehicle placebo were: Adverse Events 220 mcg of triamcinolone acetonide daily (n=127) Vehicle placebo (n=322) Epistaxis 11.0% 9.3% Cough 9.4% 9.3% Fever 7.9% 5.6% Nausea 6.3% 3.1% Throat discomfort 5.5% 5.3% Otitis 4.7% 3.7% Dyspepsia 4.7% 2.2% Adverse events occurring at a rate of 3% or greater that were more common in the placebo group were upper respiratory tract infection, headache and concurrent infection. Only 1.6% of patients discontinued due to adverse experiences. No patient discontinued due to a serious adverse event related to Nasacort therapy. Though not observed in controlled clinical trials of Nasacort Nasal Inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post-marketing surveillance of this product.