Intranasal corticosteroids may also cause a reduction in growth velocity when
administered to pediatric patients (see PRECAUTIONS , Pediatric Use
Symptomatic relief may not occur in some patients for as long as 2 weeks. Although
systemic effects are minimal at recommended doses, flunisolide nasal solution (flunisolide nasal spray .025%)
should not be continued beyond 3 weeks in the absence of significant symptomatic
improvement. In clinical studies with flunisolide administered intranasally,
the development of localized infections of the nose and pharynx with Candida
albicans has occurred only rarely. When such an infection develops it may require
treatment with appropriate local therapy or discontinuance of treatment with
flunisolide nasal solution (flunisolide nasal spray .025%) . Since there is no evidence that exceeding the maximum
recommended dose of flunisolide nasal solution (flunisolide nasal spray .025%) is more effective, higher doses
should be avoided. Patients should be advised to clear their nasal passages
of secretions prior to use. Flunisolide nasal solution (flunisolide nasal spray .025%) should not be used in
the presence of untreated local infection involving the nasal mucosa. Flunisolide
should be used with caution, if at all, in patients with active or quiescent
tuberculosis infection, fungal, bacterial or systemic viral infections or ocular
As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of flunisolide nasal sprays. Temporary or permanent loss of the sense of smell and taste have also been reported with the use of flunisolide nasal sprays.
Because of the inhibitory effect of corticosteroids on wound healing, a nasal corticosteroid should be used with caution in patients who have experienced recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, until healing has occurred.
Although systemic corticoid effects typical of Cushing's syndrome are minimal with recommended doses of topical steroids, this potential increases with excessive doses. If recommended doses are exceeded with long-term use, or if individuals are particularly sensitive, symptoms of hypercorticism could occur including suppression of hypothalamic-pituitary-adrenal function and/or retardation of growth in pediatric patients. Therefore, larger than recommended doses of flunisolide nasal solution (flunisolide nasal spray .025%) should be avoided.
Information for Patients
Patients should use flunisolide nasal solution (flunisolide nasal spray .025%) at regular intervals since its effectiveness depends on its regular use. Patients should take the medication as directed and should not exceed the prescribed dose. A decrease in symptoms can be expected to occur within a few days of initiating therapy in allergic rhinitis patients. Patients should contact their physician if the condition worsens, if sneezing or nasal irritation occurs, or if symptoms do not improve by 3 weeks.
Persons taking immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
For proper use of this unit and to attain maximum improvement, the patient
should read and follow the accompanying Patient Instructions
Long-term studies were conducted in mice and rats using oral administration to evaluate the carcinogenic potential of the drug. Flunisolide was administered to mice at doses of 5, 50 and 500 mcg/kg/day (15, 150 and 1500 mcg/m2 respectively), and to rats at doses of 0.5, 1 and 2.5 mcg/kg/day (3.0, 5.9 and 14.8 mcg/m2 respectively). There was an increase in the incidence of benign pulmonary adenomas in mice, but not in rats. Female rats receiving the highest oral dose had an increased incidence of mammary adenocarcinoma compared to control rats. An increased incidence of this tumor type has been reported for other corticosteroids.
Impairment of Fertility
Female rats receiving high doses of flunisolide (200 mcg/kg/day or 1180 mcg/m2 body surface area) showed some evidence of impaired fertility. Reproductive performance in the low (8 mcg/kg/day or 47.2 mcg/m2 and mid-dose (40 mcg/kg/day or 236 mcg/m2) groups was comparable to controls.
Pregnancy Category C. As with other corticosteroids, flunisolide has been shown
to be teratogenic and fetotoxic in rabbits and rats at oral doses of 40 and
200 mcg/kg/day (480 mcg/m2 and 1180 mcg/m2) respectively.
There are no adequate and well-controlled studies in pregnant women. Flunisolide
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when flunisolide is administered to nursing women.
Flunisolide nasal solution (flunisolide nasal spray .025%) is not recommended for use in pediatric patients
less than 6 years of age as safety and efficacy have not been assessed in this
age group. For pediatric patients 6 years of age and over, recommended maximum
daily doses should not be exceeded in order to minimize the risk of systemic
corticoid effects, including potential growth retardation. (See Individualization
Of Dosage and DOSAGE AND ADMINISTRATION.)
Controlled clinical studies have shown that intranasal corticosteroids may cause
a reduction in growth velocity in pediatric patients. This effect has been observed
in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA)
axis suppression, suggesting that growth velocity is a more sensitive indicator
of systemic corticosteroid exposure in pediatric patients than some commonly
used tests of HPA axis function. The long-term effects of this reduction in
growth velocity associated with intranasal corticosteroids, including the impact
on final adult height, are unknown. The potential for "catch up" growth
following discontinuation of treatment with intranasal corticosteroids has not
been adequately studied. The growth of pediatric patients receiving intranasal
corticosteroids, including flunisolide nasal solution (flunisolide nasal spray .025%) , 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.
Clinical studies of flunisolide nasal solution (flunisolide nasal spray .025%) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.