Flunisolide Spray
Loading...Flunisolide Spray Recall
Get an alert when a recall is issued.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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
Chemical Name:
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%.
Sources
Flunisolide Spray Manufacturers
-
Rising Pharmaceuticals, Inc
![Flunisolide Spray, Metered [Rising Pharmaceuticals, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Flunisolide Spray | Rising Pharmaceuticals, Inc
Adults: the recommended starting dose of flunisolide nasal solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day). If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day).
Pediatric Patients 6 to 14 years: The recommended starting dose of flunisolide nasal solution is 1 spray, (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day). Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy studies, including possible adverse effects on growth, have not been conducted.
Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day). Since there is no evidence that exceeding the maximum recommended dosage is more effective and increased systemic absorption would occur, higher doses should be avoided.
After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms. Approximately 15% of patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day.
For priming and repriming of nasal spray unit after storage: The patient should remove the dust cover. Put two fingers on "shoulders” of pump unit, and place thumb on the bottom of the bottle. Push the bottle with thumb FIRMLY and QUICKLY 5-6 times or until a fine spray appears. Now your pump is primed. The patient must prime the pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning.
DIRECTIONS FOR USE: A patient leaflet of instructions accompanies each package of flunisolide nasal solution.
WARNING: Do not spray in eyes.
-
Rising Pharmaceuticals, Inc
Flunisolide Spray | Rising Pharmaceuticals, Inc
Adults: the recommended starting dose of flunisolide nasal solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day). If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day).
Pediatric Patients 6 to 14 years: The recommended starting dose of flunisolide nasal solution is 1 spray, (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day). Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy studies, including possible adverse effects on growth, have not been conducted.
Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day). Since there is no evidence that exceeding the maximum recommended dosage is more effective and increased systemic absorption would occur, higher doses should be avoided.
After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms. Approximately 15% of patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day.
For priming and repriming of nasal spray unit after storage: The patient should remove the dust cover. Put two fingers on "shoulders” of pump unit, and place thumb on the bottom of the bottle. Push the bottle with thumb FIRMLY and QUICKLY 5-6 times or until a fine spray appears. Now your pump is primed. The patient must prime the pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning.
DIRECTIONS FOR USE: A patient leaflet of instructions accompanies each package of flunisolide nasal solution.
WARNING: Do not spray in eyes.
![Flunisolide Spray, Metered [Rising Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3f3d300d-a843-4da8-90d1-7a1a4c283c51&name=3f3d300d-a843-4da8-90d1-7a1a4c283c51-11.jpg)
Login To Your Free Account