Drug products: Budesonid Mylan, Budesonid Orifarm, Desonix, Livicort, Rhinocort Aqua, Rhinocort Turbuhaler, Rhinocort® Aqua, Rhinocort® Turbuhaler®
ATC code: R01AD05
No sex differences in pharmacokinetics or safety have been found. Published controlled studies on differences between men and women in efficacy of intranasal budesonide are lacking.
In a study in healthy volunteers receiving 400 µg budesonide nasal spray (7 men, 8 women), no major sex differences in pharmacokinetic parameters were found .
Three pharmacokinetic studies conducted by the sponsor revealed no major sex differences in most of the pharmacokinetic parameters of budesonide nasal spray . Systemic exposure of budesonide in pharmacokinetic studies showed no sex differences in budesonide pharmacokinetics .
No studies with a clinically relevant sex analysis regarding the effects of intranasal budesonide have been found.
A double-blind placebo-controlled study in children age 2-5 years (51 boys, 27 girls) with allergic rhinitis evaluated effect and safety of budesonide aqueous nasal spray once-daily dose. Types of adverse events in the treatment group were comparable to those in the placebo group and no differences between boys and girls in reported adverse events were noticed .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2017-03-02
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson