Budesonide – intranasal
Classification: AATC code: R01AD05
Summary
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.
Additional information
Pharmacokinetics and dosing
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 [1].
Three pharmacokinetic studies conducted by the sponsor revealed no major sex differences in most of the pharmacokinetic parameters of budesonide nasal spray [2]. Systemic exposure of budesonide in pharmacokinetic studies showed no sex differences in budesonide pharmacokinetics [2].
Effects
No studies with a clinically relevant sex analysis regarding the effects of intranasal budesonide have been found.
Adverse effects
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 [3].
Reproductive health issues
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Updated: 2019-04-08
Date of litterature search: 2017-03-02
References
- Rhinocort Aqua (budesonid spray) metered. DailyMed [www]. US National Library of Medicine. [updated 2017-01-06, cited 2017-03-02]. länk
- Food and Drug Aministration (FDA). Clinical Pharmacology and Biopharmaceutics Review - Rhinocort Aqua (budesonide) Nasal Spray. Food and Drug Administration [www]. [updated 2001-06-19, cited 2017-03-02]. länk
- Kim KT, Rabinovitch N, Uryniak T, Simpson B, O'Dowd L, Casty F. Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis. Ann Allergy Asthma Immunol. 2004;93:61-7. PubMed
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-03-23.] länk
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson