General: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 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 albicanshas occurred only rarely. When such an infection develops, it may require treatment with appropriate local therapy or discontinuance of treatment with flunisolide. 

Flunisolide is absorbed into the circulation. Use of excessive doses of flunisolide may suppress HPA function. Flunisolide should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract or in untreated fungal, bacterial or systemic 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.

Information for Patients:Patients should use flunisolide at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of flunisolide are fully manifested. One to two weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, or if the condition worsens, or if sneezing or nasal irritation occurs. 

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying Patient Instructions carefully.

Patients should be advised to clear their nasal passages of secretions prior to use.

Carcinogenesis, Mutagenesis, Impairment of Fertility:In mice, flunisolide at an oral dose of 500 mcg/kg/day (approximately 6 times the maximum recommended daily intranasal dose in adults and children on a mg/m 2basis) for 21 months was negative for carcinogenic effects. In rats, administration of flunisolide at an oral dose of 2.5 mcg/kg/day (less than the maximum recommended daily intranasal dose in adults and children on a mg/m 2basis) for 24 months resulted in an increased incidence of mammary gland adenoma and islet cell adenoma of the pancreas in females. There were no significant increases in the incidence of any tumor type in rats at an oral dose of 1 mcg/kg (less than the maximum recommended daily intranasal dose in adults and children on a mg/m 2basis). 

Flunisolide showed no mutagenic activity in in vitrotest systems including the Ames Assay and the Rec-Assay, and no clastogenic activity in either the in vitrochromosomal aberration assay in Chinese hamster lung fibroblast cells or the in vivomouse 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 2basis) 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 2basis). 

Pregnancy: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, respectively (approximately 2 and 4 times, respectively, the maximum recommended daily intranasal dose in adults on a mg/m 2basis). 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. 

Nursing Mothers: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. 

Pediatric Use:Flunisolide Nasal Solution 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. 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 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, 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. 

Geriatric Use:Clinical studies of Flunisolide Nasal Solution 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 reduction for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.