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Basic Drug Info
Drug Name:flunisolide
Manufacturer:Apotex Corp.
Other Info:

Patient InstructionsRx OnlyFlunisolide Nasal Solution USP, 0.025% (Nasal Spray)(29 mcg flunisolide per spray)Note:  Not identical to the 25 mcg flunisolide per sprayNasal Spray Unit With the Preset (Preassembled) PumpYour flunisolide nasal solution nasal spray unit with the pump is already assembled.

Please follow the directions below to prepare it for your use.IMPORTANT INFORMATION ON FLUNISOLIDE NASAL SOLUTION USP, 0.025% (NASAL SPRAY):You should use Flunisolide Nasal Solution USP, 0.025% (Nasal Spray) at regular intervals as directed since is effectiveness depends on its regular use (see below).It may take 1-2 weeks before full relief is obtained.You should contact your physician if symptoms do not improve, if the condition worsens, or if sneezing, nasal irritation, or bleeding occurs.You should contact your physician if you know you have been exposed to chicken pox or measles.Manufactured by:                                                        Manufactured for:Apotex Inc.

                                                                 Apotex Corp.Richmond Hill, Ontario                                                Weston, FL  33326Canada L4C 5H2125570                                                                                                                               June 2006 



Clinical Trials:


Indications and Usage
Flunisolide nasal solution is indicated for the management of the nasal symptoms of seasonal or perennial rhinitis.
Contraindications
Hypersensitivity to any of the ingredients.  Flunisolide nasal solution should not be used in the presence of untreated localized infection involving the nasal mucosa.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Focal infection --

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.
Branded Drugs
The following US Branded drugs contain flunisolide


AEROBID -- ROCHE PALO ALTO LLC

AEROSPAN HFA -- FOREST LABORATORIES INC

NASALIDE -- IVAX RESEARCH INC

NASAREL -- TEVA GLOBAL RESPIRATORY RESEARCH LLC


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