pramipexole

Pramipexole (Mirapex) is used for the treatment of Parkinson's disease (PD) and restless leg syndrome (RLS).

Is Mirapex available as a generic drug?

Generics are available for the immediate release tablets. Generics of the extended release tablets are not available.

Do I need a prescription for Mirapex?

Yes

WARNING

Falling Asleep During Activities of Daily Living

Patients treated with Mirapex (pramipexole dihydrochloride) tablets have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on Mirapex tablets, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment.

Before initiating treatment with Mirapex tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Mirapex tablets such as concomitant sedating medications, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels.

If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), Mirapex tablets should ordinarily be discontinued. If a decision is made to continue Mirapex tablets, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Common side effects

The most common side effects reported are:

• nausea,
• dizziness,
• somnolence (sleepiness),
• difficulty sleeping,
• constipation,
• weakness (asthenia),
• orthostatic hypotension (low blood pressure),
• movement disorder (extrapyramidal syndrome),
• dry mouth,
• amnesia (memory impairment), and
• urinary frequency.

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.

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:

• prochlorperazine (Compazine, Compro, Procomp),
• chlorpromazine (Promapar, Thorazine),
• fluphenazine (Permitil, Prolixin),
• haloperidol (Haldol),
• thioxanthenes (Navane), and
• metoclopramide (Reglan).

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 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.