Pramipexole

Pramipexole is a prescription medication used to treat Parkinson's Disease and Restless Legs Syndrome. Pramipexole belongs to a group of drugs called dopamine agonists which work by binding to dopamine receptors in the brain, helping to control movement.

This medication comes in tablet form and is usually taken 3 times daily for Parkinson's Disease and once daily, at bedtime, for Restless Legs Syndrome. Pramipexole tablets can be taken with or without food.

This medication also comes as an extended release tablet and is taken once a day, with or without food. Swallow extended release tablet whole. Do not chew, crush, or divide extended release tablets.

Common side effects include nausea, dizziness, and drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.

Pramipexole immediate release tablets is a prescription medicine used to treat Restless Legs Syndrome and the signs and symptoms of Parkinson's disease.

Pramipexole extended release tablets is a prescription medicine used to treat signs and symptoms of Parkinson's disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pramipexole may be found in some form under the following brand names:

• Mirapex

• Mirapex ER

Pramipexole may cause serious side effects. See "Drug Precautions" section.

The most common side effects in people taking pramipexole for Restless Legs Syndrome are nausea and sleepiness.

The most common side effects in people taking pramipexole for Parkinson’s disease are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements and herbal products. Be sure to mention any of the following:

• amantadine (Symadine, Symmetrel)
• antidepressants
• antihistamines
• cimetidine (Tagamet)
• diltiazem (Cardiazem, Dilacor XR)
• levodopa (Larodopa, Dopar, in Sinemet)
• medications for allergies, anxiety, mental illness, nausea, and seizure
• metoclopramide (Reglan)
• quinidine
• quinine
• ranitidine (Zantac, Zantac 75)
• sedatives
• sleeping pills
• tranquilizers
• triamterene (Dyrenium, in Dyazide, in Maxzide)
• and verapamil (Isoptin, Calan, Verelan, and others)

This is not a complete list of pramipexole drug interactions. Ask your doctor or pharmacist for more information.

Pramipexole may cause serious side effects, including:

• falling asleep during normal daily activities. Pramipexole may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating.
  • Some people taking the medicine in pramipexole have had car accidents because they fell asleep while driving.
  • Some patients did not feel sleepy before they fell asleep while driving. You could fall asleep without any warning.
    Tell your doctor right away if you fall asleep while you are doing activities such as talking, eating, driving, or if you feel sleepier than normal for you.
• low blood pressure when you sit or stand up quickly. You may have:
  • dizziness
  • nausea
  • fainting
  • sweating
    Sit and stand up slowly after you have been sitting or lying down.
• unusual urges. Some people who take certain medicines to treat Parkinson’s disease, including pramipexole, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive.
  If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.
• seeing visions, hearing sounds or feeling sensations that are not real (hallucinations). Your chance of having hallucinations is higher if you are elderly (age 65 or older).
  If you have hallucinations, talk with your doctor right away.
• uncontrolled sudden movements (dyskinesia). If you have new dyskinesia or your existing dyskinesia gets worse tell your doctor.
• skin cancer (melanoma). Some people with Parkinson’s disease may have a higher chance of having melanoma than people who do not have Parkinson’s disease. It is not known if the chance of having melanoma is higher because of the medicines to treat Parkinson’s disease, like pramipexole, or from the Parkinson’s disease. People who take pramipexole should have regular skin examinations to check for melanoma.

Do not drink alcohol while taking pramipexole. It can increase your chance of having serious side effects. 

Do not drive a car, operate a machine, or do other dangerous activities until you know how pramipexole affects you. Sleepiness caused by pramipexole can happen as late as 1 year after you start your treatment.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pramipexole there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor about all of your medical conditions, including if you:

• are allergic to pramipexole or any other medicine
• feel sleepy during the day from a sleep problem other than Restless Legs Syndrome
• have low blood pressure, or if you feel dizzy or faint, especially when getting up from a lying or sitting position
• have trouble controlling your muscles (dyskinesia)
• have kidney problems
• are pregnant or breastfeeding
• drink alcohol. Alcohol can increase the chance that pramipexole will make you feel sleepy or fall asleep when you should be awake.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pramipexole falls into category C. There are no well-controlled studies in pregnant women. Pramipexole should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if pramipexole is excreted in human breast milk or if it will harm your nursing baby.

• Take pramipexole exactly as your doctor tells you to. Your doctor will tell you how many pramipexole tablets to take and when to take them.
• Your doctor may change your dose until you are taking the right amount of medicine to control your symptoms. Do not take more or less pramipexole than your doctor tells you to.
• Pramipexole can be taken with or without food. Taking pramipexole with food may lower your chances of getting nausea.
• If you miss a dose, do not double your next dose. Skip the dose you missed and take your next regular dose.
• Be sure to tell your doctor right away if you stop taking pramipexole for any reason. Do not start taking pramipexole again before speaking with your doctor. If you have Parkinson’s disease and are stopping pramipexole, you should stop pramipexole slowly over 7 days.

Take pramipexole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Pramipexole comes as a tablet and an extended release tablet to take by mouth.

Immediate release tablets:

Parkinson's disease

• When pramipexole is used to treat Parkinson's disease, it is usually taken three times a day.
• The recommended starting dose is 0.375 mg given once daily. The maximum recommended dose is 4.5 mg per day.

Restless Legs Syndrome

• When pramipexole is used to treat restless legs syndrome, it is usually taken once a day, 2 to 3 hours before bedtime. 
• The recommended starting dose is 0.125 mg given once daily, 2-3 hours before bedtime. The maximum recommended dose is 0.5 mg per day.

Your doctor will start you on a low dose of pramipexole and gradually increase your dose. Your doctor will probably not increase your dose more often than once every 4 to 7 days. It may take several weeks before you reach a dose that works for you.

Your dose will be reduced based on your kidney function.

Extended release tablets:

Pramipexole extended release tablets when treating Parkinson's disease, is usually taken once a day.

The recommended starting dose is 0.375 mg given once daily. The maximum recommended dose is 4.5 mg per day.

If you take too much pramipexole, call your local Poison Control Center or seek emergency medical attention right away.

• Store pramipexole tablets at room temperature [77°F (25°C)]. Short-term exposure to higher or lower temperatures [from 59°F (15°C) to 86°F (30°C)] is acceptable. Ask your doctor or pharmacist if you have any questions about storing your tablets.
• Keep pramipexole out of light.
• Keep pramipexole and all medicines out of the reach of children.