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Formulation

OMNARIS combines desirable characteristics
into 1 formulation

Trademarks and registered trademarks are the property of their respective owners.

†† ≤70 mcL.

** BKC (benzalkonium chloride) is a preservative contained in many INS products and can be an irritant.2,9

OMNARIS 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 mucosa2,10,11
  • Ciclesonide is a prodrug that is rapidly converted to active des-ciclesonide after nasal administration1,12

OMNARIS Stays

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

  • Binds to the glucocorticoid receptors1,12
    OR
  • Forms reversible fatty acid conjugates1,12

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.

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Relief is here program $11 COPAY EVERY TIME*

Best-in-class copay program for qualifying patients on every prescription fill

Find out how

* Restrictions apply. Maximum savings of up to $50, on up to 12 prescription fills of OMNARIS per calendar year. See program rules and eligibility requirements

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.
  • 3. Nasonex [prescribing information]. Kenilworth, NJ: Schering Corporation; September 2005.
  • 4. Veramyst [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; September 2009.
  • 5. Wingertzahn MA, Takanashi K, Nagano A, Namiki Y, Sakon K, Makino Y. Persistence and effusion clearance to esophagus of ciclesonide in hypotonic and isotonic suspensions [abstract]. J Allergy Clin Immunol. 2006;117(suppl):S260.
  • 6. Nasacort AQ [prescribing information]. Bridgewater, NJ: Sanofi-Aventis US LLC; September 2008.
  • 7. Rhinocort Aqua [prescribing information]. Wilmington, DE: AstraZeneca LP; January 2005.
  • 8. Mahadevia PJ, Shah S, Leibman C, Kleinman L, O’Dowd L. Patient preferences for sensory attributes of intranasal corticosteroids and willingness to adhere to prescribed therapy for allergic rhinitis: a conjoint analysis. Ann Allergy Asthma Immunol. 2004;93(4):345-350.
  • 9. Riechelmann H, Deutschle T, Stuhlmiller A, Gronau S, Bürner H. Nasal toxicity of benzalkonium chloride. Am J Rhinol. 2004;18(5):291-299.
  • 10. Pennington AK, Ratcliffe JH, Wilson CG, Hardy JG. The influence of solution viscosity on nasal spray deposition and clearance. Int J Pharm. 1988;43:221-224.
  • 11. Sharpe SA, Sandweiss V, Tuazon J, Giordano M, Witchey-Lakshmanan L, Sequeira J. Comparison of the flow properties of mometasone furoate nasal spray with other nasal corticosteroid sprays [abstract]. J Allergy Clin Immunol. 2002;109(suppl):S106.
  • 12. Sato H, Nave R, Nonaka T, Mochizuki T, Takahama S, Kondo S. In vitro metabolism of ciclesonide in human nasal epithelial cells. Biopharm Drug Dispos. 2007;28(1):43-50.

© 2011 Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., and is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.
OMNARIS is a registered trademark of Nycomed GmbH, used with permission.