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Important Safety Information & Indication

In clinical studies, local nasal effects of epistaxis were observed with OMNARIS® (ciclesonide) Nasal Spray. Instances of nasal septal perforations have been reported in patients following the intranasal application of corticosteroids. No cases of nasal septal perforation were identified in clinical studies with OMNARIS Nasal Spray. In clinical studies, the development of localized infections of the nose or pharynx with Candida albicanshas occurred. Patients using OMNARIS Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse reactions on the nasal mucosa. Corticosteroids can interfere with wound healing.

Prior to initiating therapy, examine patients for evidence of septal perforation, erosions, ulceration, nasal surgery, and trauma. Avoid spraying OMNARIS Nasal Spray directly onto the nasal septum. Avoid use in patients with recent septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma. Monitor patients periodically for signs of adverse reactions on the nasal mucosa. Discontinue OMNARIS Nasal Spray if erosions, ulcerations or perforations occur.

Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray. Cases of hypersensitivity reactions following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx have been reported.

Patients who are using immunosuppressant doses of corticosteroids are more susceptible to infections than healthy individuals. Chicken pox and measles can have a more serious or even fatal course in susceptible individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.

When intranasal corticosteroids are used at very high dosages or at the regular dosage in susceptible individuals, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, discontinue OMNARIS Nasal Spray slowly.

Corticosteroids may cause a reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving OMNARIS Nasal Spray.

In short-term (2 to 6 weeks) studies in patients 12 and older, the most common adverse reactions that occurred with an incidence of at least 2% and more frequently with OMNARIS Nasal Spray than with placebo were headache (6.0%), epistaxis (4.9%), nasopharyngitis (3.7%), and ear pain (2.2%). In clinical studies 2 to 12 weeks in duration in children 6 to 11 years of age, the most common adverse reactions that occurred with an incidence of at least 2% and more frequently with OMNARIS Nasal Spray than with placebo were headache (6.6%), nasopharyngitis (6.6%) and pharyngolaryngeal pain (3.4%).

For additional information, please see the OMNARIS Nasal Spray Full Prescribing Information.

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