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Detailed Drug Information for the Consumer > pramipexole

pramipexole (Oral route)

pram-i-PEX-ole

Commonly used brand name(s):

In the U.S.

  • Mirapex

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Dopamine Agonist

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Uses For pramipexole

Pramipexole is used to treat Parkinson's disease. It may be used alone, or in combination with levodopa or other medicines to treat this disease.

Pramipexole is also used to treat a condition called Restless Legs Syndrome (RLS). RLS is a neurologic disorder that affects sensation and movement in the legs and causes the legs to feel uncomfortable. This results in an irresistible feeling of wanting to move your legs to make them comfortable .

pramipexole is available only with your doctor's prescription.

Before Using pramipexole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pramipexole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pramipexole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on pramipexole have been done only in adult patients, and there is no specific information comparing use of pramipexole in children with use in other age groups.

Geriatric

Hallucinations (seeing, hearing, or feeling things that are not there) may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of pramipexole. Also, elderly patients are more likely to have age-related kidney disease, which may require caution in patients receiving pramipexole.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Using pramipexole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cimetidine
  • Kava

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pramipexole. Make sure you tell your doctor if you have any other medical problems, especially:

  • Eye problems, especially with the retina—Animal studies have shown that problems with the retina may occur; it is not certain if this may occur in humans.
  • Dyskinesia (trouble controlling your muscles) or
  • Hallucinations (seeing, hearing, or feeling things that are not there) or
  • Hypotension (low blood pressure) or
  • Postural hypotension (dizziness, lightheadedness, or fainting, especially when getting up from a lying or sitting position)—Pramipexole may make these conditions worse .
  • Kidney problems—Higher blood levels of pramipexole may result, and cause an increase in side effects.


Proper Use of pramipexole

Take pramipexole every day exactly as directed by your doctor in order to improve your condition as much as possible. Do not take more of it or less of it, and do not take it more or less often than your doctor ordered.

Dosing

The dose of pramipexole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pramipexole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For Parkinson's disease:
      • Adults—At first, 0.125 milligram (mg) three times a day. Your doctor will increase your dose gradually as needed and tolerated. However, the dose usually is not more than 4.5 mg a day.
      • Children—Use and dose must be determined by your doctor.
    • For Restless Legs Syndrome:
      • Adults—At first, 0.125 milligram (mg) once a day two to three hours before bedtime. Your doctor will increase your dose gradually as needed and tolerated. However, the dose usually is not more than 0.5 mg a day.
      • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of pramipexole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pramipexole

It is important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to reduce any unwanted effects.

Do not stop taking pramipexole without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

pramipexole may cause some people to become drowsy, dizzy or lightheaded, or to have vision problems, weakness, or problems with coordination. Make sure you know how you react to pramipexole before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

Patients receiving pramipexole have reported falling asleep while engaged in daily living activities, including the operation of motor vehicles. Some patients have further reported that they were fully alert just prior to falling asleep and had no warning signs such as excessive drowsiness.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. These symptoms are more likely to occur when you begin taking pramipexole, or when the dose is increased. Getting up slowly may help. If you should have this problem, check with your doctor.

Alcohol or medicines that make you drowsy may add to the effects of pramipexole. Be sure your doctor knows if you are taking alcohol or other medicines that may cause drowsiness .

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients. This is more common with elderly patients .

It is important that your doctor check your skin for melanoma regularly if you have Parkinson's disease .

Some people who have used pramipexole had unusual changes in their behavior, such as having problems with gambling, increased sex drive, or compulsive eating. Talk with your doctor if this is a concern for you .

pramipexole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Dizziness, lightheadedness, or fainting, especially when standing up
  • drowsiness
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • nausea
  • trouble in sleeping
  • twitching, twisting, or other unusual body movements
  • unusual tiredness or weakness
Less common
  • Confusion
  • cough
  • difficulty in swallowing
  • double vision or other changes in vision
  • falling asleep without warning;
  • fearfulness, suspiciousness, or other mental changes
  • fever
  • frequent urination
  • memory loss
  • muscle or joint pain
  • muscle weakness
  • restlessness or need to keep moving
  • shortness of breath
  • swelling of body
  • tightness in chest
  • troubled breathing
  • wheezing
  • writhing, twisting, or other unusual body movements
Rare
  • Abnormal thinking
  • anxiety
  • bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • dizziness
  • frequent urge to urinate
  • loss of bladder control
  • mood or mental changes
  • swelling of arms or legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • dryness of mouth
  • headache
  • heartburn, indigestion, or acid stomach
Less common
  • Abnormal dreams
  • decreased sexual drive or ability
  • general feeling of discomfort or illness
  • increased cough
  • increased sweating
  • itching
  • joint pain
  • loss of appetite
  • runny nose
  • skin problems, such as rash or itching
  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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