Drug products: Budenofalk, Budenofalk®, Budesonid Orifarm, Cortiment, Entocir, Entocord, Entocort, Entocort®, Intesticort, Jorveza, Nefecon
ATC code: A07EA06
Published controlled studies on differences between men and women in efficacy and safety of oral budesonide for local effect in colon are lacking. Pharmacokinetic studies have not shown any large sex differences of oral budesonide and pharmacokinetic studies regarding sex differences for rectal foam are lacking.
The present evidence concerning differences between men and women is limited but do not motivate differentiation in dosing or treatment.
According to pharmacokinetic studies conducted by the manufacturer, plasma protein binding of oral budesonide was estimated to be 85-90% in the concentration range 1-230 nmol/L and independent of sex .
Budesonide capsules given in three different dosage regimens (3 mg, 9 mg and 15 mg) to healthy volunteers (8 men, 5 women) in an open cross-over randomized study showed no pharmacokinetic differences between men and women. A study in patients with Crohn’s Disease receiving 18 mg budesonide CIR pellets showed no sex differences in pharmacokinetics .
In a post hoc analysis of four RCTs (30 men, 93 women) investigating oral budesonide as treatment in collagenous colitis, multivariate analysis showed that sex and age were not among risk factors for symptom relapse .
No studies with a clinically relevant sex analysis regarding adverse effects of oral budesonide have been found.
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