What is Mirapexin?
Mirapexin is a medicine that contains the active substance pramipexole. It comes in the form of white "immediate-release" tablets (round: 0.088 mg, 0.7 mg and 1.1 mg; oval: 0.18 mg and 0.35 mg) and in the form of white "prolonged-release tablets. "(round: 0.26 mg and 0.52 mg; oval: 1.05 mg, 2.1 mg and 3.15 mg). Immediate-release tablets release the active ingredient immediately, while prolonged-release tablets release it slowly over a few hours.
What is Mirapexin used for?
Mirapexin is used to treat the symptoms of the following diseases:
• Parkinson's disease, which is a progressive mental disorder that causes tremor, slow movement and muscle stiffness; Mirapexin can be used alone or in combination with levodopa (another medicine for Parkinson's disease), at any stage of the disease including the later stages when the effect of levodopa becomes less effective;
• moderate to severe restless legs syndrome, a disorder that causes the patient to move their legs uncontrollably to stop the sensations of discomfort, pain or discomfort in the body, especially at night; Mirapexin is used when a specific cause of the disorder cannot be identified.
The medicine can only be obtained with a prescription.
How is Mirapexin used?
In the treatment of Parkinson's disease, the starting dose is either one 0.088 mg immediate-release tablet three times a day or one 0.26 mg prolonged-release tablet once a day.
Every five to seven days the dose should be increased until symptoms are controlled without causing undesirable effects that cannot be tolerated. The maximum daily dose is three 1.1 mg immediate-release tablets three times a day or one 3.15 mg prolonged-release tablet once daily. Patients can switch from immediate-release to prolonged-release tablets overnight, but the dose may be adjusted according to the patient's response. Mirapexin should be administered less frequently in patients with kidney problems. If for any reason the treatment is stopped, the dose should be decreased gradually.
In the treatment of restless legs syndrome, Mirapexin immediate-release tablets should be taken once a day, two to three hours before bedtime. The recommended starting dose is 0.088 mg but, if necessary, it can be increased every 4-7 days to further reduce symptoms, up to a maximum of 0.54 mg. The patient's response and the need for further treatment should be evaluated after three months. Prolonged-release tablets are not suitable for the treatment of restless legs syndrome. Mirapexin tablets are taken with water, with or without food. The prolonged-release tablets should not be chewed, divided or crushed and should be taken at approximately the same time each day. For more information, see the package leaflet.
How does Mirapexin work?
The active substance in Mirapexin, pramipexole, is a dopamine agonist (a substance that mimics the action of dopamine). Dopamine is a messenger substance contained in the brain areas that control movement and coordination. In patients with Parkinson's disease, the dopamine-producing cells begin to die, resulting in a decrease in the amount of dopamine in the brain. Patients therefore lose the ability to reliably control their movements. Pramipexole stimulates the brain just as dopamine would, allowing patients to control their movements and to reduce the signs and symptoms of Parkinson's disease, including tremors, stiffness and slowed movements. The mechanism of action of pramipexole in restless legs syndrome is not yet fully understood. This syndrome is thought to be caused by alterations in dopamine functioning in the brain, which can be corrected with pramipexole.
How has Mirapexin been studied?
In Parkinson's disease, Mirapexin immediate-release tablets have been studied in five main studies. Four studies compared Mirapexin with placebo (a dummy treatment): a study involving 360 patients in advanced stages of the disease, already being treated with levodopa, whose effectiveness was starting to wear off; three studies involving a total of 886 patients in an early stage of the disease, not yet treated with levodopa. The main measure of effectiveness was the change in the severity of Parkinson's disease. The fifth study compared Mirapexin with levodopa in 300 patients with early disease and measured the number of patients with motor symptoms. In support of it. of the prolonged-release tablets, the company presented the results of studies showing that the immediate-release and prolonged-release tablets produced the same levels of the active substance in the body. It also presented studies comparing the two tablets at an early and late stage of Parkinson's disease and examining patients switching from immediate-release to prolonged-release tablets.
In restless legs syndrome, Mirapexin immediate-release tablets have been studied in two main studies. The first compared Mirapexin with placebo for 12 weeks in 344 patients and measured improvement in symptoms. The second included 150 patients who took Mirapexin for six months and compared the effects of continuing Mirapexin therapy or switching to placebo. The main measure of effectiveness was how long it took before symptoms worsened.
What benefit has Mirapexin shown during the studies?
In the study in patients with advanced Parkinson's disease, subjects taking Mirapexin immediate-release tablets had greater improvements after 24 weeks of treatment with the maintenance dose than those taking placebo. Similar results were seen in the first three studies in early Parkinson's disease patients, where major improvements were seen after 4 or 24 weeks.
Mirapexin was also more effective than levodopa in improving motor symptoms in early stage disease. Further studies revealed that the prolonged-release tablets were just as effective as the immediate-release tablets in treating Parkinson's disease. They also showed that patients can safely switch from immediate-release to prolonged-release tablets even though dose adjustments have had to be made in a small number of patients.
In restless legs syndrome, immediate-release Mirapexin tablets were more effective than placebo in reducing symptoms over a 12-week period, but the difference between placebo and Mirapexin was greater after four weeks before tapering off. The results of the second study were not sufficient to demonstrate the long-term efficacy of Mirapexin.
What are the risks associated with Mirapexin?
The most common side effect with Mirapexin (seen in more than 1 in 10 patients) is nausea. In patients with Parkinson's disease, the other side effects seen in more than 1 in 10 patients are dizziness, dyskinesia (difficulty carrying movements), sleepiness and hypotension (low blood pressure). For the full list of side effects reported with Mirapexin, see the package leaflet.
Mirapexin must not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Why has Mirapexin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mirapexin's benefits are greater than its risks for the treatment of the signs and symptoms of idiopathic Parkinson's disease, alone or in combination with levodopa, and in the treatment of Moderate to severe idiopathic restless legs with dosages up to 0.54 mg base. The committee recommended that Mirapexin be given marketing authorization.
Other information about Mirapexin
On 23 February 1998 the European Commission issued to Boehringer Ingelheim International
GmbH a "Marketing Authorization" for Mirapexin, valid throughout the European Union. The "Marketing Authorization" was renewed on February 23, 2003 and February 23, 2008.
For the full version of Mirapexin's EPAR, click here.
Last update of this summary: 07-2009.
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