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Prucalopride

Classification: B

Drug products: Prucalopride axunio, Prucalopride Ebb, Prucalopride Orifarm, Prucalopride STADA, Prukaloprid Evolan, Resolor®

ATC code: A06AX05

Substances: prucalopride, prucalopride succinate

Summary

Published controlled long-term studies in larger patient populations on differences between men and women in prucalopride efficacy and safety are lacking.

Additional information

Pharmacokinetics and dosing

A single-center, open-label study with healthy volunteers (14 men, 14 women) showed that men, compared to women, exhibited a slightly lower exposure of prucalopride. However,  similar changes of bowel habits were observed in both sexes suggesting that  pharmacokinetic sex differences may  not be clinically relevant [1].

Effects

No studies with a clinically relevant sex analysis regarding the effects of prucalopride have been found.

Adverse effects

No studies with a clinically relevant sex analyses regarding adverse effects of prucalopride have been found.

Reproductive health issues

Prucalopride is not recommended during pregnancy and in women of childbearing potential not using contraception [2]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

In a large British registry study (82450 men, 153264 women), the prevalence of constipation was almost twice as high among women up to the age of 75 years, but higher in men than women among patients aged over 75 years. There was no difference between men and women in choice of laxative (macrogol, lactulose, senna or other laxatives including ispaghula).  The most commonly prescribed laxative in pregnant patients with constipation were lactulose followed by macrogol [3].

Updated: 2020-08-27

Date of litterature search: 2020-03-17

References

  1. Chen X, Jiang J, Liu T, Liu H, Zhong W, Hu P. Pharmacokinetics of single and repeated oral doses prucalopride in healthy Chinese volunteers. Int J Clin Pharmacol Ther. 2012;50(11):797-804. PubMed
  2. Resolor (prucalopride). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2019-12-19, cited 2020-03-17].
  3. Shafe AC, Lee S, Dalrymple JS, Whorwell PJ. The LUCK study: Laxative Usage in patients with GP-diagnosed Constipation in the UK, within the general population and in pregnancy An epidemiological study using the General Practice Research Database (GPRD). Therap Adv Gastroenterol. 2011;4:343-63. PubMed
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Authors: Emelie Elfving

Reviewed by: Diana Rydberg, Carl-Olav Stiller

Approved by: Karin Schenck-Gustafsson