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pramipexole

Pronunciation

Generic Name: pramipexole (pram i PEX ole)
Brand Name: Mirapex, Mirapex ER

What is pramipexole?

Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Pramipexole is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Pramipexole is also used to treat restless legs syndrome (RLS).

Pramipexole may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pramipexole?

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking pramipexole.

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If you are taking this medication for rest leg syndrome (RLS), tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pramipexole. Tell your doctor if you regularly use any of these other medicines.

Drinking alcohol can increase certain side effects of pramipexole.

Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

What should I discuss with my healthcare provider before taking pramipexole?

You should not use pramipexole if you are allergic to it.

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

To make sure you can safely take pramipexole, tell your doctor if you have any of these other conditions:

  • low blood pressure;

  • kidney disease; or

  • tremors (dyskinesia) or uncontrolled muscle movements.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking pramipexole. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking pramipexole.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

How should I take pramipexole?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

The dose and timing of pramipexole in treating Parkinson's disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label.

Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pramipexole?

Pramipexole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of pramipexole.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Pramipexole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking pramipexole and call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, falling asleep suddenly, even after feeling alert;

  • nausea, sweating, feeling light-headed, fainting;

  • hallucinations;

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;

  • chest pain, cough with white or pink phlegm (mucus), wheezing;

  • feeling short of breath (even with mild exertion), swelling, rapid weight gain;

  • feeling weak or tired, loss of appetite, rapid weight loss;

  • fast or uneven heartbeats; or

  • tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Less serious side effects may include:

  • dry mouth, stomach pain, vomiting, constipation;

  • headache, dizziness, spinning sensation;

  • mild drowsiness;

  • swelling in your hands or feet;

  • appetite or weight changes;

  • blurred vision;

  • sleep problems (insomnia), unusual dreams;

  • amnesia, forgetfulness, thinking problems; or

  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Pramipexole Dosing Information

Usual Adult Dose for Parkinson's Disease:

Pramipexole immediate-release:
Initial dose: 0.125 mg orally three times a day with or without food.
Maintenance dose: The dosage should be titrated gradually to the desired clinical effect. Generally, the dosage may be increased every 5 to 7 days based on efficacy and tolerability, up to a maximum of 4.5 mg/day (given as 1.5 mg three times a day). The efficacy of dosages beyond 4.5 mg/day has not been established.

Pramipexole extended-release:
Initial dose: 0.375 mg once daily with or without food.
Maintenance dose: The dosage should be titrated gradually to the desired clinical effect. Generally, the dosage may be increased every 5 to 7 days based on efficacy and tolerability, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. The efficacy of dosages beyond 4.5 mg/day has not been established.

Usual Adult Dose for Restless Legs Syndrome:

Pramipexole immediate-release:
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime. If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maintenance dose: 0.5 mg orally once a day 2 to 3 hours before bedtime.

Pramipexole extended-release is not indicated for Restless Legs Syndrome.

What other drugs will affect pramipexole?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pramipexole. Tell your doctor if you regularly use any of these medicines, or any other medicines for Parkinson's disease.

Tell your doctor about all other medicines you use, especially:

  • amantadine (Symmetrel);

  • cimetidine (Tagamet);

  • diltiazem (Cardizem, Cartia, Dilacor, Tiazac);

  • ranitidine (Zantac);

  • quinidine (Quin-G);

  • quinine (Qualaquin);

  • triamterene (Dyrenium);

  • verapamil (Calan, Covera, Isoptin);

  • medicine to prevent or treat nausea and vomiting, such as metoclopramide (Reglan, Metozolv) or promethazine (Pentazine, Phenergan, Anergan, Antinaus); or

  • medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), thiothixene (Navane), thioridazine (Mellaril), and others.

This list is not complete and other drugs may interact with pramipexole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about pramipexole.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision Date: 2012-09-22, 1:16:55 PM.

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