Drug products: 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 code: N04BC05
Substances: pramipexole, pramipexole dihydrochloride monohydrate
Clinical trials have not demonstrated any difference in adverse events between men and women with Parkinson’s disease treated with pramipexol. In patients treated for RLS (Restless Legs Syndrome) nausea and fatigue has been more frequently reported in women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
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 . 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 .
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 .
No studies with a clinically relevant sex analysis regarding the effects of pramipexole have been found.
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 .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2013-04-11
Reviewed by: Expertrådet för neurologiska sjukdomar
Approved by: Mia von Euler