Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Prukaloprid

Klassificering: B

Preparat: Resolor®

ATC kod: A06AX05

Substanser: prukaloprid, prukalopridsuccinat

Sammanfattning

För prukaloprid saknas det publicerade kontrollerade långtidsstudier på patientkohorter avseende könsskillnader.

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].

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande prukaloprid (ATC-kod A06AX05) på recept i Sverige är 2019, totalt 3 010 kvinnor och 759 män [4].

Uppdaterat: 2020-08-27

Litteratursökningsdatum: 2020-03-17

Referenser

  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

Författare: Emelie Elfving

Faktagranskat av: Diana Rydberg, Carl-Olav Stiller

Godkänt av: Karin Schenck-Gustafsson