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.
Medically reviewed by Eni Williams, PharmD, PhD
REFERENCE: FDA Prescribing Information.
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