Formulation

OMNARIS® (ciclesonide) Nasal Spray combines desirable characteristics into 1 formulation

chart_form_formulation

Trademarks and registered trademarks are the property of their respective owners.
** BKC (benzalkonium chloride) is a preservative contained in many INS products and can be an irritant.2,9

OMNARIS® (ciclesonide) Nasal Spray is designed to Stick & Stay

OMNARIS Sticks

  • Hypotonic suspension enables diffusion of water molecules into the nasal mucosa, thus increasing its viscosity2
  • Increased viscosity promotes adherence and absorption of ciclesonide into nasal mucosa2-4
  • Ciclesonide is a prodrug that is rapidly converted to active des-ciclesonide after nasal administration1,5

OMNARIS Stays

Drug retention in nasal mucosa occurs when des-ciclesonide...

  • Binds to the glucocorticoid receptors1,5,, OR
  • Forms reversible fatty acid conjugates1,5

The precise mechanism through which ciclesonide affects allergic rhinitis is unknown.

Corticosteroids have been shown to have a wide range of effects on multiple cell types and mediators involved in allergic inflammation.

 

References:
1. OMNARIS® (ciclesonide) Nasal Spray Prescribing Information. Marlborough, MA: Sunovion Pharmaceuticals Inc.; October 2011.
2. Meltzer EO. Formulation considerations of intranasal corticosteroids for the treatment of allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(1):12-21.
3. Pennington AK, Ratcliffe JH, Wilson CG, Hardy JG. The influence of solution viscosity on nasal spray deposition and clearance. Int J Pharm. 1988;43(3):221-224
4. Sharpe SA, Sandweiss V, Tuazon J, et al. Comparison of the flow properties of mometasone furoate nasal spray with other nasal corticosteroid sprays [abstract]. J Allergy Clin Immunol. 2002;109(suppl):S106.
5. Sato H, Nave R, Nonaka T, et al. In vitro metabolism of ciclesonide in human nasal epithelial cells. Biopharm Drug Dispos. 2007;28(1):43-50.
6. Ratner PH, Wingertzahn MA, van Bavel JH, et al. Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 2006;118(5):1142-1148.
7. Meltzer EO, Kunjibettu S, Hall N, et al. Efficacy and safety of ciclesonide, 200µg once daily, for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(2):175-181.
8. http://www.clinicaltrials.gov; NCT00305487. Study 060-417. Sunovion Pharmaceuticals Inc., Marlborough, MA.
9. http://www.clinicaltrials.gov; NCT00163514. Study 060-403. Sunovion Pharmaceuticals Inc., Marlborough, MA.
10. Chervinsky P, Kunjibettu S, Miller DL, et al. Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007;99(1):69-76.
11. http://www.clinicaltrials.gov; NCT00659841. Study 060-401. Sunovion Pharmaceuticals Inc., Marlborough, MA.
12. http://www.clinicaltrials.gov; NCT00163501. Study 060-404. Sunovion Pharmaceuticals Inc., Marlborough, MA.

 

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.