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Pramipexol

Klassificering: A

Preparat: Derinik, Mirapexin, MIRAPEXIN®, Oprymea, Oprymea®, Pramipexol Aurobindo, Pramipexol Sandoz, Pramipexol STADA, Pramipexol Teva Pharma, Pramipexole Accord, Pramipexole Bluefish, Pramipexole Orion, Pramipexole Sandoz, Pramipexole Teva, SIFROL, Sifrol®, SIFROL®

ATC kod: N04BC05

Substanser: pramipexol, pramipexoldihydrokloridmonohydrat

Sammanfattning

Kliniska prövningar har inte påvisat könsskillnader i biverkningar hos patienter som behandlas med pramipexol för Parkinsons sjukdom. Hos patienter som behandlas med pramipexol mot RLS (Restless Legs Syndrome) rapporterades illamående och trötthet oftare av kvinnor än män.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

Pharmacokinetics and dosing

In a pharmacokinetic study in healthy volunteers (8 men, 8 women), AUC and Cmax of pramipexol were signficantly greater in women for the dose 1.5 mg. The mean creatinine clearance was lower in women than in (80.9 ±15.6 vs. 112 ±12.8 mL/min/1.73 m2). However, women had higher mean age in this study, and aging leads to a decline in glomerular filtration rate. The normal range of glomerular filtration rate, measured by inulin clearance, is lower for women. Therefore, the influence of sex could not be distinguished from the influence of age and the resulting reduced creatinine clearance [1]. Pramipexole clearance has shown to be about 30% lower in women than in men, but this difference can be accounted for by differences in body weight. There was no difference in half-life between men and women [2].

Therapy with pramipexole should be initiated at a low dose and gradually titrated upward according to clinical tolerability to obtain the optimum therapeutic effect. It is not necessary to adjust the initial dose based on sex [2].

Effects

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

Adverse effects

No sex-related differences in adverse events have been observed among patients with Parkinson’s disease treated with pramipexole in clinical trials. Among RLS patients, nausea and fatigue were more frequently reported by women than men [2].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Försäljning på recept

Fler kvinnor än män hämtade ut tabletter innehållande pramipexol (ATC-kod N04BC05) på recept i Sverige år 2015, totalt 21 875 kvinnor och 14 126 män. Det motsvarar 4,5 respektive 2,9 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var tabletter innehållande pramipexol 1,5 gånger vanligare hos kvinnor [3].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2013-04-11

Referenser

  1. Wright CE, Sisson TL, Ichhpurani AK, Peters GR. Steady-state pharmacokinetic properties of pramipexole in healthy volunteers. J Clin Pharmacol. 1997;37:520-5. PubMed
  2. Mirapex (pramipexole dihydrochloride). DailyMed [www]. US National Library of Medicine. [updated 2013-08-01, cited 2013-09-16]. länk
  3. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Expertrådet för neurologiska sjukdomar

Godkänt av: Mia von Euler