Flunisolide Spray Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 should be carefully monitored to avoid acute adrenal insufficiency in response to stress.
When transferred to flunisolide, careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids. This is particularly important in those patients who have associated asthma or other clinical conditions, where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The use of flunisolide with alternate-day prednisone systemic treatment could increase the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, flunisolide treatment should be used with caution in patients already on alternate-day prednisone regimens for any disease.
Persons who are on drugs that 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 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 the 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.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Flunisolide nasal solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide nasal solution should not be used in the presence of untreated localized infection involving the nasal mucosa.
There is currently no drug history available for this drug.
Flunisolide Nasal Solution USP, 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of flunisolide nasal solution, is an anti-inflammatory steroid.
Flunisolide is represented by the following structural formula:
C 24H 31FO 6 Mol. Wt. 434.51
6α-fluoro-11β,16α,17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (USAN).
Flunisolide is a white to creamy white crystalline powder. It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C.
After initial priming (5 to 6 sprays), each spray of the unit delivers a metered droplet spray of 100 mg formulation containing 25 mcg of flunisolide. The size of the droplets produced by the unit is in excess of 8 microns to facilitate deposition on the nasal mucosa. The contents of one nasal spray bottle delivers 200 sprays.
Each ml. Contains: ACTIVE: Flunisolide 0.25mg (0.025%); INACTIVES: Propylene Glycol, Polyethylene Glycol 3350, Butylated Hydroxyanisole, Edetate Disodium, Sodium Ctirate, Citric Acid and Purified Water, Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1-5.4), PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.