FDA label 6b7fdebe-7f0f-bc2b-34ba-92d8aac020f2

WARNINGS The replacement of a systemic corticosteroid with 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 flunisolide nasal solution should be carefully monitored to avoid acute adrenal insufficiency in response to stress. Careful attention must also be given to patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroids may exacerbate their symptoms. The use of flunisolide nasal solution with systemic prednisone as alternate day therapy or with daily doses of less than 7.5 mg could increase the likelihood of hypothalamic-pituitary-adrenal axis suppression compared to a therapeutic dose of either one alone. Therefore, flunisolide nasal solution treatment should be used with caution in patients already on prednisone regimens for any disease. Persons 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 nonimmune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a nonimmune patient is exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package insert for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered.

ADVERSE REACTIONS The adverse events rates listed below are based on symptoms spontaneously reported in multidose controlled clinical trials in comparing flunisolide nasal solution (29 mcg per spray) and flunisolide nasal solution (25 mcg per spray) for treatment of allergic rhinitis. In patients receiving flunisolide nasal solution the most common adverse events were transient aftertaste (17%) and transient nasal burning and stinging (13%). These symptoms did not usually interfere with treatment. Adverse Event Rates for Flunisolide Nasal Solution (29 mcg per spray) Incidence Greater than 1% (probably casually related) Respiratory: Nasal burning/stinging (13%), epistaxis*, nasal dryness, pharyngitis, cough increased Gastrointestinal: Nausea Special Senses: Aftertaste (17%) Incidence 1% or Less (probably casually related) Respiratory: Hoarseness Special Senses: Abnormal sense of smell Incidence 1% or Less (casual relationship unknown) Respiratory: Sinusitis Adverse Event Rates for Flunisolide Nasal Solution (25 mcg per spray) Incidence Greater than 1% (probably casually related) Respiratory: Nasal burning/stinging (44%), epistaxis*, nasal dryness*, pharyngitis*, cough increased Gastrointestinal: Nausea Special Senses: Aftertaste (8%) Incidence 1% or Less (probably casually related) Respiratory: Hoarseness, nasal ulcer Incidence 1% or Less (casual relationship unknown) † Respiratory: Sinusitis Cases of growth suppression have been reported for intranasal corticosteroids (including flunisolide nasal solution) (see PRECAUTIONS , Pediatric Use section). * Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients † Reactions occurred under circumstances where the casual relationship has not been clearly established; they are presented as alerting information for physicians