1. COMPOSITIONEach spray delivers: Ciclesonide BP 50 mcg

2. DOSAGE FORMAqueous intranasal spray

3. PHARMACOLOGY

3.1 Pharmacodynamics

Mechanism of Action Ciclesonide is a prodrug that is enzymatically hydrolysed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide has anti-inflammatory activity with an affinity for the glucocorticoid receptor that is 120 times higher than the parent compound.

The precise mechanism by which ciclesonide affects the symptoms of allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.

4. INDICATIONS

Seasonal Allergic Rhinitis Ciclesonide Aqueous 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.

Perennial Allergic Rhinitis

Ciclesonide Aqueous Nasal Spray is indicated for the treatment of nasal symptoms associated with

perennial allergic rhinitis in adults and adolescents 12 years of age and older.