pramipexole (Mirapex, Mirapex ER)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

Do I need a prescription for Mirapex?

Yes

Why is Mirapex prescribed to patients?

Pramipexole is used for the treatment of the signs and symptoms of idiopathic Parkinson's disease, and moderate-to-severe primary restless leg syndrome.

What are the side effects of Mirapex?

The most common side effects reported are:

What is the dosage for Mirapex?

Pramipexole can be taken with or without food.

Parkinson's disease initial treatment in patients with normal kidney function: The usual recommended starting dose (using immediate release tablets) is 0.375 mg/day given in three divided doses. Dosage may be increased gradually every 5 to 7 days.

Parkinson's disease maintenance treatment: The usual recommended dose range is 1.5 to 4.5 mg/day administered in equally divided doses every 8 hours.

Restless leg syndrome dosing: The recommended starting dose is 0.125 mg taken by mouth once daily 2-3 hours before bedtime. Dosage may be increased every 4-7 hours. Dosage should be increased every 14 days in RLS patients with severe or moderate kidney impairment.

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Which drugs or supplements interact with Mirapex?

Pramipexole is a dopamine agonist. Effectiveness of pramipexole may be decreased when given with dopamine antagonists which are drugs with the opposite pharmacological effects. Examples of such drugs are:

Is Mirapex safe to use during pregnancy or while breastfeeding?

Pramipexole has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, pramipexole should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Pramipexole is classified as FDA pregnancy risk category C.

It is not known if pramipexole is excreted in breast milk. Due to the lack of conclusive safety data, pramipexole should be used cautiously in females who are breastfeeding.

What else should I know about Mirapex?

What preparations of Mirapex are available?
How should I keep Mirapex stored?

Immediate release tablets: 0.125, 0.25, 0.5, 0.75, 1, and 1.5 mg; extended release 24 hour tablets: 0.375, 0.75, 1.5, 2.25, 3, 3.75, and 4.5 mg

Tablets should be stored at room temperature, between 15 C to 30 C (59 F to 86 F). Tablets should be protected from light and kept out of the reach of children.

How does Mirapex work?

Pramipexole stimulates dopamine receptors in the brain. The exact mechanism of action of pramipexole in Parkinson's disease is unknown. However, treatment benefits are thought to be related to the stimulation of dopamine receptors in the area of the brain known as the striatum. Pramipexole may improve movement performance and activities of daily living in patients usually within 2-3 weeks of starting treatment. The exact mechanism of action of pramipexole for the treatment of RLS is unknown. Benefits of treatment are thought to be associated with stimulating dopamine receptors in the brain.

When was Mirapex approved by the FDA?
  • The US FDA approved pramipexole for the treatment of Parkinson's disease in July, 1997.
  • Extended release pramipexole (Mirapex ER) was approved by the FDA for the treatment of early Parkinson's disease in February, 2010.
  • In March 2010, the FDA extended the approval of the extended release formulation to the treatment of advanced, idiopathic Parkinson's disease.
  • Immediate release pramipexole was approved by the FDA for the treatment of moderate to severe primary RLS in November, 2006.

REFERENCE: FDA Prescribing Information.

Last Editorial Review: 11/3/2016

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Reviewed on 11/3/2016
References
REFERENCE: FDA Prescribing Information.

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