Flunisolide nasal solution is used for the symptomatic treatment of seasonal or perennial rhinitis when conventional therapy with antihistamines or decongestants is ineffective or produces intolerable adverse effects. In a comparative study in patients with seasonal allergic rhinitis, flunisolide nasal solution as Nasalide or Nasarel was more effective than either placebo vehicle, but there was no statistically significant difference in efficacy between the 2 flunisolide formulations; neither of these formulations currently is commercially available in the US. The US Food and Drug Administration (FDA) has determined that the generic (nonproprietary) formulation currently available in the US (Bausch & Lomb) is bioequivalent (and therefore therapeutically equivalent) to the previously available Nasalide formulation.
In patients with seasonal or perennial rhinitis of allergic or nonallergic etiology, intranasal administration of flunisolide generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing, postnasal drip, and pharyngeal itching. However, intranasal flunisolide generally does not relieve symptoms of conjunctivitis or those involving the lower respiratory tract; this may reflect the absence of appreciable systemic activity when usual dosages of the drug are administered by nasal inhalation.
Flunisolide nasal solution appears to provide greater symptomatic relief in patients with allergic rhinitis (i.e., associated with IgE-mediated reactivity manifested as positive skin tests to common allergens or increased serum or nasal IgE concentrations) than in patients with nonallergic rhinitis. When intranasal flunisolide is added to a therapeutic regimen that includes an oral antihistamine, dosage of the antihistamine can often be decreased in allergic patients with seasonal or perennial rhinitis even during periods of peak exposure to pollen. Although the efficacy of intranasal flunisolide in the treatment of perennial nonallergic rhinitis has been questioned, most clinicians agree that a therapeutic trial with the drug is warranted in these patients since greater symptomatic relief occurs during intranasal flunisolide therapy than during intranasal placebo therapy. However, in one study in patients with perennial nonallergic rhinitis, intranasal flunisolide was no more effective than placebo, although both treatments resulted in measurable symptomatic improvement; it was suggested that the observed symptomatic relief may have resulted from the moisturizing effects of the vehicle in flunisolide nasal solution.
In patients with seasonal or perennial rhinitis, symptomatic relief is usually evident within 2-3 days of continuous intranasal flunisolide therapy; however, up to 2-3 weeks may be required for optimum effectiveness in some patients. Supplemental therapy with topical nasal decongestants and/or oral antihistamines may be necessary until an acceptable clinical response is achieved. In some patients, therapy with ophthalmic preparations may be necessary to relieve signs and symptoms of conjunctivitis not controlled by intranasal corticosteroids. Although ophthalmic products containing vasoconstrictors and antihistamines or corticosteroids may be effective in relieving ophthalmic inflammatory symptoms in patients with rhinitis, concurrent use of ophthalmic and intranasal corticosteroids is not generally recommended since the risk of adverse ophthalmic effects associated with corticosteroid therapy (e.g., glaucoma, cataract formation, exacerbation of ophthalmic infections) may be increased. In some patients with seasonal or perennial rhinitis, especially those with concurrent asthmatic conditions, continuous concomitant therapies (e.g., oral or orally inhaled corticosteroids, bronchodilators, antihistamines, decongestants) may be required to provide optimum symptomatic relief.
A poor clinical response to flunisolide can result from improper drug administration techniques, poor drug penetration (secondary to marked nasal congestion, presence of nasal polyps, or symptoms originating in the nasal sinuses), or localized infections of the nasal mucosa.
Intranasal administration of flunisolide (200 mcg/day in 2 divided doses) appears to be as effective as intranasal beclomethasone dipropionate (400 mcg/day in 4 divided doses) in the treatment of seasonal or perennial allergic rhinitis. In some patients with nasal crusting and dryness, flunisolide nasal solution may be more useful than beclomethasone dipropionate nasal aerosol since the vehicle for flunisolide may contribute to the overall therapeutic effect in these patients. Unlike beclomethasone dipropionate nasal aerosol, flunisolide nasal solution does not contain fluorocarbons which have been associated with excessive drying of the nasal mucosa in some patients. When intranasal flunisolide is administered concomitantly with orally inhaled beclomethasone dipropionate to patients with both perennial allergic rhinitis and asthma, the combination therapy generally results in greater overall symptomatic relief than either drug alone.
Data from an unpublished study indicate that intranasal flunisolide (200 mcg/day) is as effective as intranasal dexamethasone phosphate (670 mcg/day) in the treatment of perennial rhinitis. Although the symptomatic relief provided by usual dosages of intranasal flunisolide, beclomethasone dipropionate, or dexamethasone phosphate is similar, flunisolide and beclomethasone dipropionate appear to be associated with fewer adverse systemic effects than dexamethasone phosphate; however, no direct comparison of the adverse effects of these drugs has been performed.
Following nasal inhalation in one study in patients with seasonal allergic rhinitis, flunisolide and cromolyn sodium provided similar symptomatic relief. However, intranasal flunisolide was more effective in relieving sneezing, and oral antihistamine dosage requirements were reduced to a greater extent in patients receiving flunisolide. Further comparative studies of intranasal flunisolide and intranasal cromolyn sodium are needed.
Intranasal flunisolide has been used for the treatment of serous otitis media (eustachian tube dysfunction, middle ear effusion) in children. In one study, flunisolide-treated children had an accelerated return to normal middle ear pressure compared with placebo-treated children; however, the specific role of the drug in the treatment of this condition has not been determined.
Although orally inhaled flunisolide is used in the treatment of asthma, the manufacturer recommends that the nasal solution not be used for this purpose, since the safety of polyethylene glycol in the vehicle of the nasal solution has not been established for this route of administration.
For other uses of flunisolide, see 68:04.