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Budesonide – local effect in colon

Classification: A

Drug products: Budenofalk, Budenofalk®, Budesonid Orifarm, Cortiment, Entocir, Entocord, Entocort, Entocort®, Intesticort, Jorveza, Nefecon

ATC code: A07EA06

Summary

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.

Additional information

Pharmacokinetics and dosing

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 [1].

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 [2].

Effects

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 [3].

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of oral budesonide have been found.

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: 2017-03-02

References

  1. Entocort EC (budesonide) capsule. DailyMed [www]. US National Library of Medicine. [updated 2011-12-27, cited 2017-03-02]. länk
  2. Clinical Pharmacology and Biopharmaceutics Review - Entocort (budesonide capsules). Food and Drug Administration [www]. [updated 2001-11-20, cited 2017-03-02]. länk
  3. Miehlke S, Hansen JB, Madisch A, Schwarz F, Kuhlisch E, Morgner A et al. Risk factors for symptom relapse in collagenous colitis after withdrawal of short-term budesonide therapy. Inflamm Bowel Dis. 2013;19:2763-7. PubMed
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-03-23.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson