Drug products: Prucalopride Orifarm, Resolor®
ATC code: A06AX05
Substances: prucalopride, prucalopride succinate
Published controlled long-term studies in larger patient populations on differences between men and women in prucalopride efficacy and safety are lacking.
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 .
No studies with a clinically relevant sex analysis regarding the effects of prucalopride have been found.
No studies with a clinically relevant sex analyses regarding adverse effects of prucalopride have been found.
Prucalopride is not recommended during pregnancy and in women of childbearing potential not using contraception . Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
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 .
Date of litterature search: 2020-03-17
Reviewed by: Diana Rydberg, Carl-Olav Stiller
Approved by: Karin Schenck-Gustafsson