Skip to main content
SpringerLink
Log in

Mometasone Furoate Nasal Spray

A Review of Safety and Systemic Effects

  • Review Article
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

The development of corticosteroids that are delivered directly to the nasal mucosa has alleviated much of the concern about the systemic adverse effects associated with oral corticosteroid therapy. However, given the high potency of these drugs and their widespread use in the treatment of allergic rhinitis, it is important to ensure that intranasal corticosteroids have a favourable benefit-risk ratio. One agent that typifies the systemic safety found in the majority of intranasal corticosteroids is mometasone furoate nasal spray, a potent and effective treatment for seasonal and perennial allergic rhinitis and nasal polyposis. Mometasone furoate does not reach high systemic concentrations or cause clinically significant adverse effects. Results from pharmacokinetic studies in adults and children suggest that systemic exposure to mometasone furoate after intranasal administration is negligible. This is probably because of the inherently low aqueous solubility of mometasone furoate, which allows only a small fraction of the drug to cross the nasal mucosa and enter the bloodstream, and because a large amount of the administered drug is swallowed and undergoes extensive first-pass metabolism. There is no clinical evidence that mometasone furoate nasal spray suppresses the function of the hypothalamus-pituitary-adrenal axis when the drug is administered at clinically relevant doses (100–200 μg/day); consequently, mometasone furoate nasal spray has not been associated with growth inhibition in children. The safety and tolerability of mometasone furoate nasal spray have been rigorously assessed in clinical trials involving approximately 4500 patients, with epistaxis, headache and pharyngitis being the most common adverse effects associated with treatment in adolescents and adults.

The clinical effectiveness of mometasone furoate nasal spray, coupled with its agreeable safety and tolerability profile, confirms its favourable benefit-risk ratio.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Table I

Similar content being viewed by others

References

  1. American Academy of Allergy, Asthma and Immunology. The allergy report: II. Diseases of the atopic diathesis [online]. Available from URL: http://www.aaaai.org/ar/volume2.pdf [Accessed 2006 Jun 16]

  2. Bousquet J, van Cauwenberge P, Khaltaev N, et al. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001; 108Suppl. 5: S147–334

    Article  PubMed  CAS  Google Scholar 

  3. Naclerio RM. Allergic rhinitis. N Engl J Med 1991; 325(12): 860–9

    Article  PubMed  CAS  Google Scholar 

  4. Stanbury RM, Graham EM. Systemic corticosteroid therapy: side effects and their management. Br J Ophthalmol 1998; 82(6): 704–8

    Article  PubMed  CAS  Google Scholar 

  5. Tattersfield AE, Harrison TW, Hubbard RB, et al. Safety of inhaled corticosteroids. Proc Am Thorac Soc 2004; 1(3): 171–5

    Article  PubMed  CAS  Google Scholar 

  6. Lipworth BJ, Jackson CM. Safety of inhaled and intranasal corticosteroids: lessons for the new millennium. Drug Saf 2000; 23(1): 11–33

    Article  PubMed  CAS  Google Scholar 

  7. Allen DB. Systemic effects of intranasal steroids: an endocrinologist’s perspective. J Allergy Clin Immunol 2000; 106Suppl. 4: S179–90

    Article  PubMed  CAS  Google Scholar 

  8. Esmailpour N, Högger P, Rohdewald P. Binding of glucocorticoids to human nasal tissue in vitro. Int Arch Allergy Immunol 2000; 122(2): 151–4

    Article  PubMed  CAS  Google Scholar 

  9. Cave A, Arlett P, Lee E. Inhaled and nasal corticosteroids: factors affecting the risks of systemic adverse events. Pharmacol Ther 1999; 83(3): 153–79

    Article  PubMed  CAS  Google Scholar 

  10. Derendorf H, Hochhaus G, Meibohm B, et al. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol 1998; 101(4): S440–6

    Article  PubMed  CAS  Google Scholar 

  11. Davies RJ, Nelson HS. Once-daily mometasone furoate nasal spray: efficacy and safety of a new intranasal glucocorticoid for allergic rhinitis. Clin Ther 1997; 19(1): 27–38

    Article  PubMed  CAS  Google Scholar 

  12. Smith CL, Kreutner W. In vitro glucocorticoid receptor binding and transcriptional activation by topically active glucocorticoids. Arzneimittelforschung 1998; 48(9): 956–60

    PubMed  CAS  Google Scholar 

  13. Berkowitz RB, Roberson S, Zora J, et al. Mometasone furoate nasal spray is rapidly effective in the treatment of seasonal allergic rhinitis in an outdoor (park), acute exposure setting. Allergy Asthma Proc 1999; 20(3): 167–72

    Article  PubMed  CAS  Google Scholar 

  14. Bronsky EA, Aaronson DW, Berkowitz RB, et al. Dose ranging study of mometasone furoate (Nasonex) in seasonal allergic rhinitis. Ann Allergy Asthma Immunol 1997; 79(1): 51–6

    Article  PubMed  CAS  Google Scholar 

  15. Graft D, Aaronson D, Chervinsky P, et al. A placebo- and active-controlled randomized trial of prophylactic treatment of seasonal allergic rhinitis with mometasone furoate aqueous nasal spray. J Allergy Clin Immunol 1996; 98(4): 724–31

    Article  PubMed  CAS  Google Scholar 

  16. Hebert JR, Nolop K, Lutsky BN. Once-daily mometasone furoate aqueous nasal spray (Nasonex) in seasonal allergic rhinitis: an active- and placebo-controlled study. Allergy 1996; 51(8): 569–76

    PubMed  CAS  Google Scholar 

  17. Meltzer EO, Berger WE, Berkowitz RB, et al. A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis. J Allergy Clin Immunol 1999; 104(1): 107–14

    Article  PubMed  CAS  Google Scholar 

  18. Drouin M, Yang WH, Bertrand B, et al. Once daily mometasone furoate aqueous nasal spray is as effective as twice daily beclomethasone dipropionate for treating perennial allergic rhinitis patients. Ann Allergy Asthma Immunol 1996; 77(2): 153–60

    Article  PubMed  CAS  Google Scholar 

  19. Mandl M, Nolop K, Lutsky BN, et al. Comparison of once daily mometasone furoate (Nasonex) and fluticasone propionate aqueous nasal sprays for the treatment of perennial rhinitis. Ann Allergy Asthma Immunol 1997; 79(4): 370–8

    Article  PubMed  CAS  Google Scholar 

  20. Bende M, Carrillo T, Vona I, et al. A randomized comparison of the effects of budesonide and mometasone furoate aqueous nasal sprays on nasal peak flow rate and symptoms in perennial allergic rhinitis. Ann Allergy Asthma Immunol 2002; 88(6): 617–23

    Article  PubMed  CAS  Google Scholar 

  21. Small CB, Hernandez J, Reyes A, et al. Efficacy and safety of mometasone furoate nasal spray in nasal polyposis. J Allergy Clin Immunol 2005; 116(6): 1275–81

    Article  PubMed  CAS  Google Scholar 

  22. Stjärne P, Mosges R, Jorissen M, et al. A randomized controlled trial of mometasone furoate nasal spray for the treatment of nasal polyposis. Arch Otolaryngol Head Neck Surg 2006; 132(2): 179–85

    Article  PubMed  Google Scholar 

  23. Meltzer EO, Charous BL, Busse WW, et al. Added relief in the treatment of acute recurrent sinusitis with adjunctive mometasone furoate nasal spray. J Allergy Clin Immunol 2000; 106(4): 630–7

    Article  PubMed  CAS  Google Scholar 

  24. Nayak AS, Settipane GA, Pedinoff A, et al. Effective dose range of mometasone furoate nasal spray in the treatment of acute rhinosinusitis. Ann Allergy Asthma Immunol 2002; 89(3): 271–8

    Article  PubMed  CAS  Google Scholar 

  25. Brannan MD, Herron JM, Affrime MB. Safety and tolerability of once-daily mometasone furoate aqueous nasal spray in children. Clin Ther 1997; 19(6): 1330–9

    Article  PubMed  CAS  Google Scholar 

  26. Daley-Yates PT, Kunka RL, Yin Y, et al. Bioavailability of fluticasone propionate and mometasone furoate aqueous nasal sprays. Eur J Clin Pharmacol 2004; 60(4): 265–8

    Article  PubMed  CAS  Google Scholar 

  27. Schenkel E. Features of mometasone furoate nasal spray and its utility in the management of allergic rhinitis. Expert Opin Pharmacother 2003; 4(9): 1579–91

    Article  PubMed  CAS  Google Scholar 

  28. Teng XW, Cutler DJ, Davies NM. Mometasone furoate degradation and metabolism in human biological fluids and tissues. Biopharm Drug Dispos 2003; 24(8): 321–33

    Article  PubMed  CAS  Google Scholar 

  29. Skoner DP, Gentile D, Angelini B, et al. The effects of intranasal triamcinolone acetonide and intranasal fluticasone propionate on short-term bone growth and HPA axis in children with allergic rhinitis. Ann Allergy Asthma Immunol 2003; 90(1): 56–62

    Article  PubMed  CAS  Google Scholar 

  30. Lipworth BJ, Seckl JR. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 1997; 52(5): 476–82

    Article  PubMed  CAS  Google Scholar 

  31. Brannan MD, Herron JM, Reidenberg P. Lack of HPA axis suppression following 36 days of intranasal mometasone furoate [abstract no. P207]. American College of Allergy, Asthma and Immunology Annual Meeting; 1997 Nov 7-12; San Diego (CA). Ann Allergy Asthma Immunol 1997; 78: 154

    Google Scholar 

  32. Brannan MD, Seiberling M, Cutler DL, et al. Lack of systemic activity with intranasal mometasone furoate [abstract]. J Allergy Clin Immunol 1996; 97Suppl.: S198

    Article  Google Scholar 

  33. Wilson AM, Sims EJ, McFarlane LC, et al. Effects of intranasal corticosteroids on adrenal, bone, and blood markers of systemic activity in allergic rhinitis. J Allergy Clin Immunol 1998; 102(4): 598–604

    Article  PubMed  CAS  Google Scholar 

  34. Lee DKC, Robb FM, Sims EJ, et al. Systemic bioactivity of intranasal triamcinolone and mometasone in perennial allergic rhinitis. Br J Clin Pharmacol 2003; 55(3): 310–3

    Article  PubMed  CAS  Google Scholar 

  35. Galant SP, Melamed IR, Nayak AS, et al. Lack of effect of fluticasone propionate nasal spray on the hypothalamic-pituitary-adrenal axis in 2- and 3-year-old patients. Pediatrics 2003; 112(1): 96–100

    Article  PubMed  Google Scholar 

  36. Cutler DL, Banfield C, Melton B, et al. Safety of mometasone furoate nasal spray in children with allergic rhinitis as young as 2 years of age: a randomized controlled trial. Pediatr Asthma Allergy Immunol 2006; 19(3): 146–53

    Article  Google Scholar 

  37. Schenkel EJ, Skoner DP, Bronsky EA, et al. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics 2000; 105(2): E22

    Article  PubMed  CAS  Google Scholar 

  38. Dibildox J. Safety and efficacy of mometasone furoate aqueous nasal spray in children with allergic rhinitis: results of recent clinical trials. J Allergy Clin Immunol 2001; 108Suppl. 1: S54–8

    Article  PubMed  CAS  Google Scholar 

  39. Gawchik S, Goldstein S, Prenner B, et al. Relief of cough and nasal symptoms associated with allergic rhinitis by mometasone furoate nasal spray. Ann Allergy Asthma Immunol 2003; 90(4): 416–21

    Article  PubMed  CAS  Google Scholar 

  40. Lundblad L, Sipila P, Farstad T, et al. Mometasone furoate nasal spray in the treatment of perennial non-allergic rhinitis: a Nordic, multicenter, randomized, double-blind, placebo-controlled study. Acta Otolaryngol 2001; 121(4): 505–9

    Article  PubMed  CAS  Google Scholar 

  41. Meltzer EO, Jalowayski AA, Orgel HA, et al. Subjective and objective assessments in patients with seasonal allergic rhinitis: effects of therapy with mometasone furoate nasal spray. J Allergy Clin Immunol 1998; 102(1): 39–49

    Article  PubMed  CAS  Google Scholar 

  42. Salib RJ, Howarth PH. Safety and tolerability profiles of intranasal antihistamines and intranasal corticosteroids in the treatment of allergic rhinitis. Drug Saf 2003; 26(12): 863–93

    Article  PubMed  CAS  Google Scholar 

  43. Benninger MS, Hadley JA, Osguthorpe JD, et al. Techniques of intranasal steroid use. Otolaryngol Head Neck Surg 2004; 130(1): 5–24

    Article  PubMed  Google Scholar 

  44. Marple B, Roland P, Benninger M. Safety review of benzalkonium chloride used as a preservative in intranasal solutions: an overview of conflicting data and opinions. Otolaryngol Head Neck Surg 2004; 130(1): 131–41

    Article  PubMed  Google Scholar 

  45. Kerscher MJ, Hart H, Korting HC, et al. In vivo assessment of the atrophogenic potency of mometasone furoate, a newly developed chlorinated potent topical glucocorticoid as compared to other topical glucocorticoids old and new. Int J Clin Pharmacol Ther 1995; 33(4): 187–9

    PubMed  CAS  Google Scholar 

  46. Minshall E, Ghaffar O, Cameron L, et al. Assessment by nasal biopsy of long-term use of mometasone furoate aqueous nasal spray (Nasonex) in the treatment of perennial rhinitis. Otolaryngol Head Neck Surg 1998; 118(5): 648–54

    PubMed  CAS  Google Scholar 

  47. Bross-Soriano D, Hanenberg-Milver C, Schimelmitz-Idi J, et al. Effects of three nasal topical steroids in the intraocular pressure compartment. Otolaryngol Head Neck Surg 2004; 130(2): 187–91

    Article  PubMed  Google Scholar 

  48. Derby L, Maier WC. Risk of cataract among users of intranasal corticosteroids. J Allergy Clin Immunol 2000; 105(5): 912–6

    Article  PubMed  CAS  Google Scholar 

  49. Howland WC III. Fluticasone propionate: topical or system effects? Clin Exp Allergy 2004; 26Suppl. 3: 18–22

    Google Scholar 

  50. Opatowsky I, Feldman RM, Gross R, et al. Intraocular pressure elevation associated with inhalation and nasal corticosteroids. Ophthalmology 1995; 102(2): 177–9

    PubMed  CAS  Google Scholar 

  51. Ernst P, Baltzan M, Deschenes J, et al. Low-dose inhaled and nasal corticosteroid use and the risk of cataracts. Eur Resp J 2006; 27(6): 1168–74

    Article  CAS  Google Scholar 

Download references

Acknowledgements

Funding for the preparation of this manuscript was provided by Schering-Plough. Dr Zitt reports being a consultant for Schering-Plough, Alcon, Sanofi Aventis, Greer Laboratories, Verus Pharmaceuticals, Aerocrine and Altana, and having received honoraria from Sanofi Aventis, Altana, Schering-Plough, Aerocrine, Verus Pharmaceuticals, Merck, Genentech and Novartis.

Drs Kosoglou and Hubbell are employees of Schering-Plough.

The authors wish to thank Andrew Gannon, medical writer, and Jayne Harrison, editor, of Gardiner-Caldwell London and Judy Andraski and Matthew Cahill, editors, of Adelphi inc. for assistance in the writing and editing of this manuscript.

Author information

Authors and Affiliations

  1. Queens Long Island Medical Group, State University of New York, Stony Brook, 300 Bayshore Road North Babylon, New York, New York, 11703, USA

    Myron Zitt

  2. Schering-Plough Research Institute, Kenilworth, New Jersey, USA

    Teddy Kosoglou & James Hubbell

Authors
  1. Myron Zitt
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Teddy Kosoglou
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. James Hubbell
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Myron Zitt.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Zitt, M., Kosoglou, T. & Hubbell, J. Mometasone Furoate Nasal Spray. Drug-Safety 30, 317–326 (2007). https://doi.org/10.2165/00002018-200730040-00004

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00002018-200730040-00004

Keywords

Search

Navigation