Ciclesonide 50 µg/spray; aqueous nasal spray.
Treatment of seasonal allergic rhinitis in patients ≥6 years old and perennial allergic rhinitis in patients ≥12 years old.
Omnaris is an alcohol-free, hypotonic suspension formulation of the corticosteroid ciclesonide, which is administered as a nasal spray that is scent-free and delivers a low spray volume. Following intranasal application, ciclesonide is hydrolyzed to its active metabolite, desciclesonide, by esterases in the nasal mucosa.
Corticosteroids have a wide range of effects on various cell types (e.g., eosinophils, neutrophils) and mediators of inflammation (e.g., histamine, leukotrienes, cytokines). The precise mechanism(s) of action of ciclesonide in the treatment of allergic rhinitis has not been established.
The safety and efficacy of ciclesonide nasal spray was evaluated in four randomized, double-blind, placebo-controlled trials in adults and adolescents with allergic rhinitis. Three studies, which were two to six weeks in duration, included 1,524 patients 12-86 years of age with seasonal or perennial allergic rhinitis. Treatment with ciclesonide 200 µg once daily resulted in statistically significantly greater decreases in total nasal symptom scores (runny nose, nasal itching/congestion, sneezing) than treatment with placebo.
Other studies showed that the significant effects of ciclesonide 200 µg/day were maintained over the 24-hour dosing interval. Onset of effect was seen within 24-48 hours, with further symptomatic improvement seen over one to two weeks in seasonal allergic rhinitis and over five weeks in perennial allergic rhinitis.
In a two-week study involving children 6-11 years old, ciclesonide 200 µg/day was shown to be statistically significantly different from placebo in patients with seasonal allergic rhinitis; the 100-µg/day dose was not statistically significantly different from placebo. In a 12-week study, none of the ciclesonide doses were statistically significantly different from placebo in patients 6-11 years old with perennial allergic rhinitis.
Two sprays in each nostril once daily (200 µg/day).
Seasonal allergic rhinitis: <6 years: not recommended. ³ 6 years: two sprays in each nostril once daily (200 µg/day).
Respiratory tract TB. Infections (e.g., ocular herpes simplex). Unhealed nasal wounds. If adrenal suppression exists following systemic corticosteroid therapy, replacement with topical steroids may exacerbate symptoms of adrenal insufficiency. If exposed to measles or chickenpox, consider immunoglobulin prophylactic therapy. Re-evaluate if no improvement after two weeks (for seasonal allergic rhinitis) and five weeks (for perennial allergic rhinitis). Monitor for growth suppression in children. Monitor for hypercorticism and hypothalamic-pituitary-adrenal axis suppression (if occur, discontinue gradually), and for candidal infection and other nasal mucosal changes. Monitor for vision changes or if history of glaucoma or cataracts. Avoid eyes. Pregnancy (Cat. C). Nursing mothers.
May be potentiated by ketoconazole.
Headache, epistaxis, nasopharyngitis, ear pain.
Nasal spray (pump)—12.5 g (120 sprays).
For more information, call 800.739.0565 or visit www.Omnaris.com