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Fluticasone – nasal spray

Classification: A

Drug products: Avamys, Flixonase Nasal, Flixotide Nasal, Flutaide® Nasal, Flutide® Nasal, Flutikason 2care4, Flutikason Orifarm, Flutikason Teva, Otrason

ATC code: R01AD08, R01AD12

Summary

One study of fluticasone propionate aqueous nasal spray in children showed similar effect and safety in boys and girls. However, few girls were included in the study.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

Both men and women have been included in most of the pharmacokinetic studies of intranasal fluticasone. However, no analysis of sex differences have been found and sex-divided data is lacking [1, 2].

Effects

In a randomized single dose placebo-controlled study assessing the efficacy and safety of fluticasone propionate aqueous nasal spray  with perennial allergic rhinitis (107 boys, 20 girls) , no differences in effect or safety between boys and girls were found [3, 4].

Adverse effects

A study that retrospectively reviewed records of clinical cases and side effects reports in the Swedish Medical Products Agency's statistics from 1981 to 2005 found that the most common risk factor for septum perforation was nasal steroid (including budesonide, beclomethasone, and fluticasone).  The risk of perforation was greatest during the first 12 months of treatment and most cases were in young women 73% [5]. The explanation for such higher tendency for women is unclear.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2016-12-13

References

  1. Rosenblut A, Bardin PG, Muller B, Faris MA, Wu WW, Caldwell MF et al. Long-term safety of fluticasone furoate nasal spray in adults and adolescents with perennial allergic rhinitis. Allergy. 2007;62:1071-7. PubMed
  2. Allen A, Down G, Newland A, Reynard K, Rousell V, Salmon E et al. Absolute bioavailability of intranasal fluticasone furoate in healthy subjects. Clin Ther. 2007;29:1415-20. PubMed
  3. Ngamphaiboon J, Thepchatri A, Chatchatee P, Chumdermpadetsuk S. Fluticasone propionate aqueous nasal spray treatment for perennial allergic rhinitis in children. Ann Allergy Asthma Immunol. 1997;78:479-84. PubMed
  4. Selover D, Dana T, Smith C, Peterson K. Drug Class Review: Nasal Corticosteroids. Oregon Health & Science University. PubMed
  5. Cervin A, Andersson M. Intranasal steroids and septum perforation--an overlooked complication? A description of the course of events and a discussion of the causes. Rhinology. 1998;36:128-32. PubMed
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-12-19.] Socialstyrelsens statistikdatabas

Authors: Alaa Falemban, Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson