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Pramipexole (Oral route)

Pronunciation:

pram-i-PEX-ole

Brand Names:

  • Mirapex
  • Mirapex ER

Dosage Forms:

  • Tablet, Extended Release
  • Tablet

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Dopamine Agonist

Uses of This Medicine:

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. .

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pramipexole in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pramipexole in the elderly. However, elderly patients are more likely to develop hallucinations (seeing, hearing, or feeling things that are not there), which may require caution in patients receiving pramipexole.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Dyskinesia (trouble controlling your muscles) or
  • Hallucinations or
  • Hypotension (low blood pressure) or
  • Postural hypotension (dizziness, lightheadedness, or fainting, especially when getting up from a lying or sitting position)—Use with caution. Pramipexole may make these conditions worse.
  • Kidney problems—Higher blood levels of pramipexole may result, and cause an increase in side effects.
  • Sleep disorders or
  • Sleepiness, history of in the past—May cause side effects to be worse.

Proper Use of This Medicine:

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

Read the Patient Information leaflet before you take this medicine and each time you get your prescription refilled. Ask your doctor if you have any questions.

You may take this medicine with or without food. Taking this medicine with food may reduce nausea.

Swallow the extended-release tablets whole. Do not break, crush, or chew it.

Dosing—

The dose of this medicine 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 this medicine. 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 (extended-release tablet):
    • Adults—At first, 0.375 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4.5 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For Parkinson's disease:
      • Adults—At first, 0.125 milligram (mg) three times a day. Your doctor will gradually increase your dose as needed and tolerated. However, the dose is usually not more than 4.5 mg per 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 2 to 3 hours before bedtime. Your doctor will gradually increase your dose 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 this medicine, 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This is to allow changes in your dose and to check for any unwanted effects.

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

People taking pramipexole have reported falling asleep without warning during activities of daily living, including driving, which sometimes resulted in accidents. This may happen as late as one year after taking the medicine. Therefore, make sure you know how you react to this medicine 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.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

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 this medicine, or when the dose is increased. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients. This is more common with elderly patients. If you have hallucinations, check with your doctor.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

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

Some people who have used this medicine 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.

Side Effects of This Medicine:

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 immediately 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 with sleeping
twitching, twisting, or other unusual body movements
unusual tiredness or weakness
Less common
Confusion
cough
difficulty with 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 the body
tightness in the 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 the 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 the 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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