Mirapexin

Product Overview

About Mirapexin

Mirapexin is a medicine that contains the active substance pramipexole. It is available as ‘immediate-release’ white tablets (round: 0.088, 0.7 and 1.1 mg; oval: 0.18 and 0.35 mg) and as ‘prolonged-release’ white tablets (round: 0.26 and 0.52 mg; oval: 1.05, 1.57, 2.1, 2.62 and 3.15 mg). Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours.

What it is used for

Mirapexin is used to treat the symptoms of the following diseases: Parkinson’s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness. Mirapexin can be used either on its own or in combination with levodopa (another medicine for Parkinson’s disease), at any stage of disease including the later stages when levodopa starts becoming less effective; moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. Mirapexin is used when a specific cause for the disorder cannot be identified. The medicine can only be obtained with a prescription.

How it is used

For 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. The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated. The maximum daily dose is three 1.1-mg immediate-release tablets or one 3.15-mg prolonged-release tablet. Patients can be switched from the immediate- to the prolonged-release tablets overnight, but the dose might need to be adjusted depending on the patient’s response. Mirapexin must be given less often in patients who have problems with their kidneys. If treatment is stopped for any reason, the dose should be decreased gradually. For restless-legs syndrome, Mirapexin immediate-release tablets should be taken once a day, two to three hours before going to bed. The recommended starting dose is 0.088 mg, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of 0.54 mg. The patient’s response and the need for further treatment should be evaluated after three months. The prolonged-release tablets are not suitable for restless-legs syndrome. Mirapexin tablets should be swallowed with water. The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day.

How it works

The active substance in Mirapexin, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine). Dopamine is a messenger substance in the parts of the brain that control movement and coordination. In patients with Parkinson’s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases. The patients then lose their ability to control their movements reliably. Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’s disease, such as shaking, stiffness and slowness of movement. The way pramipexole works in restless legs syndrome is not fully understood. The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be corrected by pramipexole.

Active substance: pramipexole

Source: EMA EPAR