OMNARIS (ciclesonide) Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Important Safety Information

Patients using drugs that suppress the immune system are more susceptible to infections. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults taking corticosteroids. In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. Intranasal corticosteroids should be used with caution, if at all, in patients with tuberculosis, untreated fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.

Patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Rare instances of nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids. Close follow-up is warranted in patients with a change in vision and with a history of glaucoma and/or cataracts.

If recommended doses of intranasal corticosteroids are exceeded, or in susceptible individuals used at recommended dosages, symptoms of hypercorticism may occur. If such changes occur, topical corticosteroids should be discontinued slowly.

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including OMNARIS Nasal Spray, should be monitored routinely.

The most common side effects that may occur with OMNARIS are headache, epistaxis, nasopharyngitis and ear pain.

References

• 1. OMNARIS [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; May 2010.
• 2. Meltzer EO. Formulation considerations of intranasal corticosteroids for the treatment of allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(1):12-21.