Monday, October 10, 2016

Pramipexole Extended-Release Tablets



Pronunciation: PRAM-i-PEX-ole
Generic Name: Pramipexole
Brand Name: Mirapex ER


Pramipexole Extended-Release Tablets are used for:

Treating the signs and symptoms of early Parkinson disease. It may also be used for other conditions as determined by your doctor.


Pramipexole Extended-Release Tablets are a dopamine agonist. Exactly how Pramipexole Extended-Release Tablets works is unknown. It may increase the action of certain chemical receptors in the brain.


Do NOT use Pramipexole Extended-Release Tablets if:


  • you are allergic to any ingredient in Pramipexole Extended-Release Tablets

  • you have severe kidney problems or are on dialysis

  • you are taking another medicine that has pramipexole in it

Contact your doctor or health care provider right away if any of these apply to you.



Before using Pramipexole Extended-Release Tablets:


Some medical conditions may interact with Pramipexole Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have kidney problems, low blood pressure, lightheadedness when you sit or stand up, or daytime sleepiness

  • if you drink alcohol or have a history of compulsive behavior (eg, eating, gambling, shopping)

  • if you have trouble controlling your muscles

Some MEDICINES MAY INTERACT with Pramipexole Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Cimetidine because it may increase the risk of Pramipexole Extended-Release Tablets's side effects

  • Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, chlorpromazine), or thioxanthenes (eg, thiothixene) because they may decrease Pramipexole Extended-Release Tablets's effectiveness

  • Levodopa because the risk of its side effects may be increased by Pramipexole Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pramipexole Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Pramipexole Extended-Release Tablets:


Use Pramipexole Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Pramipexole Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.

  • Take Pramipexole Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Swallow Pramipexole Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.

  • Your dose will be started low and gradually increased to achieve the best results. Do not change your dose sooner than recommended.

  • Do not suddenly stop taking Pramipexole Extended-Release Tablets without checking with your doctor. Severe side effects, including fever, mental or mood changes, and stiff muscles, may occur.

  • If you miss a dose of Pramipexole Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss several doses, contact your doctor before you start to take Pramipexole Extended-Release Tablets again.

Ask your health care provider any questions you may have about how to use Pramipexole Extended-Release Tablets.



Important safety information:


  • Pramipexole Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Pramipexole Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol while you are using Pramipexole Extended-Release Tablets.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pramipexole Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Pramipexole Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Some patients who take Pramipexole Extended-Release Tablets have reported suddenly falling asleep while performing daily activities (eg, driving, eating, conversing). Many patients reported drowsiness before falling asleep; however, some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while using Pramipexole Extended-Release Tablets.

  • Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Pramipexole Extended-Release Tablets. Tell your doctor right away if you notice such effects.

  • Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Pramipexole Extended-Release Tablets also increases the risk of melanoma. You may need to have skin exams while you are using Pramipexole Extended-Release Tablets. Discuss any questions or concerns with your doctor.

  • Lab tests, including blood pressure or skin checks, may be performed while you use Pramipexole Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Pramipexole Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations.

  • Pramipexole Extended-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pramipexole Extended-Release Tablets while you are pregnant. It is not known if Pramipexole Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Pramipexole Extended-Release Tablets.


Possible side effects of Pramipexole Extended-Release Tablets:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; cough; dizziness; drowsiness; dry mouth; muscle spasms; nausea; stomach pain or upset; tiredness; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; balance problems; change in behavior, mood, or emotions; chest pain; confusion; decreased sexual ability; difficulty walking; fainting; hallucinations; increased urination; memory loss; muscle pain, tenderness, or weakness; new or unusual skin growths; severe or persistent drowsiness or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; swelling of the arms or legs; trouble swallowing; unusual or intense urges (eg, gambling, sexual urges); unusual twitching or muscle movements; vision changes; vivid dreams or daydreams.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Pramipexole side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; chest pain; confusion; decrease in blood pressure; difficulty moving; drowsiness; nausea; sedation; vomiting.


Proper storage of Pramipexole Extended-Release Tablets:

Store Pramipexole Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pramipexole Extended-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Pramipexole Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Pramipexole Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pramipexole Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pramipexole resources


  • Pramipexole Side Effects (in more detail)
  • Pramipexole Dosage
  • Pramipexole Use in Pregnancy & Breastfeeding
  • Drug Images
  • Pramipexole Drug Interactions
  • Pramipexole Support Group
  • 46 Reviews for Pramipexole - Add your own review/rating


Compare Pramipexole with other medications


  • Parkinson's Disease
  • Periodic Limb Movement Disorder
  • Restless Legs Syndrome
  • Tardive Dyskinesia

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