Drug products: Avamys, Flixonase Nasal, Flixotide Nasal, Flutaide® Nasal, Flutide® Nasal, Flutikason 2care4, Flutikason Ebb, Flutikason Orifarm, Flutikason Teva, Otrason
ATC code: R01AD08, R01AD12
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.
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].
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].
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% . The explanation for such higher tendency for women is unclear.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-12-13
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson