Mirapexin®/Sifrol® (pramipexole)

Mirapexin®/Sifrol® (pramipexole):
>five million patient-years of experience in Parkinson's disease

General introduction

  • Pramipexole (known under the trade names Mirapexin®, Sifrol®, Mirapex® and Pexola®) is a compound from Boehringer Ingelheim research, first approved as immediate release formulation in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD), as monotherapy or in combination with levodopa. It is currently worldwide the most prescribed dopamine agonist for the treatment of PD*
  • The new once daily Mirapexin®/Sifrol® prolonged-release formulation was granted marketing authorisation in October 2009 by the European Commission in all EU/EEA countries** for the treatment of early and advanced idiopathic PD
  • The once daily dosing of the new Mirapexin®/Sifrol® prolonged-release formulation provides added convenience for patients and their care givers with a once daily dosing. In addition, the prolonged-release formulation has been shown to cause less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of Mirapexin®/Sifrol® immediate release formulation1-4
  • Although not specifically studied for Mirapexin®/Sifrol® prolonged-release, it has been shown that adherence to PD treatment is a challenge and that once daily dosing may help improve patient compliance.1-4 Patients already taking Mirapexin®/Sifrol® immediate release may be switched to the once daily Mirapexin®/Sifrol® prolonged-release overnight, initially at the same daily dose5

* The pramipexole immediate release formulation is also approved for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome

** All 27 Member States of the European Union plus Norway and Iceland

Product characteristics

A detailed summary of the pramipexole product characteristics including safety, efficacy and tolerability profile can be found at: www.emea.europa.eu/humandocs/PDFs/EPAR/Sifrol/H-133-PI-en.pdf
Last accessed October 2009

Please be advised that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information or references provided on this website.

View references

  1. Grosset D et al. Adherence to antiparkinson medication in a multicenter European study. Mov Disord 2009 Apr 30;24(6):826-32.
  2. Poewe W et al. 33-week non-inferiority of extended- vs immediate-release pramipexole tablets in treatment of early Parkinson's disease. Abstract SC202 presented at 13th EFNS Congress 2009, Florence, Italy.
  3. Schapira A et al. Decrease in off-time for extended- and for immediate-release pramipexole in advanced Parkinson's disease. Abstract SC203 presented at 13th EFNS Congress 2009, Florence, Italy.
  4. Rascol O et al. Dosage, safety, and tolerability for overnight switching from immediate- to extended-release pramipexole in early Parkinson's disease. Abstract SC205 presented at 13th EFNS Congress 2009, Florence, Italy.
  5. Rascol O et al. Easy switching from immediate- to extended-release pramipexole in early Parkinson's disease at the same daily dosage. Poster TH-255 presented at Movement Disorders Society's 13th International Congress of Parkinson's Disease and Movement Disorders 2009, Paris, France.

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