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 chickenpox, 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 chickenpox develops, treatment with antiviral agents may be considered.

stemic viral infections or ocular herpes simplex. because of the inhibitory effect of corticosteroids on wound healing, in patients who have experienced recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, a nasal corticosteroid should be used with caution until healing has occurred. although systemic effects have been minimal with recommended doses, this potential increases with excessive dosages. therefore, larger than recommended doses should be avoided.

tive 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 the nasal spray unit after storage : the patient should remove the dust cover. put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. push bottle with thumb firmly and quickly 5-6 times or until 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.

e nasal solution in controlled studies, implying that these complaints may be related to the vehicle or the delivery system. the incidence of complaints of nasal burning and stinging decreased with increasing duration of treatment. other side effects reported at a frequency of 5% or less were: nasal congestion, sneezing, epistaxis and/or bloody mucous, nasal irritation, watery eyes, sore throat, nausea and/or vomiting, and headaches. as with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of flunisolide nasal solutions. temporary or permanent loss of the sense of smell and taste have also been reported with the use of flunisolide nasal solutions. systemic corticosteroid side effects were not reported during the controlled clinical trials. if recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, i.e., cushing’s syndrome, could occur. cases of growth suppression have been reported for intranasal corticosteroids (including flunisolide nasal solution) ( see precautions , pediatric use ) . to report suspected adverse reactions, contact ingenus pharmaceuticals, llc at 1-877-748-1970 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

ing flunisolide nasal solution, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. to minimize the systemic effects of intranasal corticosteroids, including flunisolide nasal solution, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

ss of the 6α fluorine and addition of a 6β hydroxy group. flunisolide is well absorbed but is rapidly converted by the liver to the much less active primary metabolite and to glucuronate and/or sulfate conjugates. because of first-pass liver metabolism, only 20% of the flunisolide reaches the systemic circulation when it is given orally whereas 50% of the flunisolide administered intranasally reaches the systemic circulation unmetabolized. the plasma half-life of flunisolide is 1 to 2 hours. the effects of flunisolide on hypothalamic-pituitary-adrenal (hpa) axis function have been studied in adult volunteers. flunisolide was administered intranasally as a spray in total doses over 7 times the recommended dose (2200 mcg, equivalent to 88 sprays/day) in 2 subjects for 4 days, about 3 times the recommended dose (800 mcg, equivalent to 32 sprays/day) in 4 subjects for 4 days, and over twice the recommended dose (700 mcg, equivalent to 28 sprays/day) in 6 subjects for 10 days. early morning plasma cortisol concentrations and 24-hour urinary 17-ketogenic steroids were measured daily. there was evidence of decreased endogenous cortisol production at all three doses. in controlled studies, flunisolide nasal solution was found to be effective in reducing symptoms of stuffy nose, runny nose and sneezing in most patients. these controlled clinical studies have been conducted in 488 adult patients at doses ranging from 8 to 16 sprays (200-400 mcg) per day and 127 pediatric patients at doses ranging from 6 to 8 sprays (150 to 200 mcg) per day for periods as long as 3 months. in 170 patients who had cortisol levels evaluated at baseline and after 3 months or more of flunisolide treatment, there was no unequivocal flunisolide-related depression of plasma cortisol levels. clinical studies have shown that improvement is usually apparent within a few days after starting flunisolide nasal solution. the mechanisms responsible for the anti-inflammatory action of corticosteroids and for the activity of the aerosolized drug on the nasal mucosa are unknown.

st cells or the in vivo mouse bone marrow chromosomal aberration assay. flunisolide, at an oral dose of 200 mcg/kg/day (approximately 4 times the maximum recommended daily intranasal dose in adults on a mg/m 2 basis) produced impaired fertility in female rats, but was devoid of such effect at oral doses less than or equal to 40 mcg/kg/day (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m 2 basis).

heir nasal passages of secretions prior to use.