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 disease. It may be used alone or in combination with other medicines (eg, levodopa). Pramipexole is a dopamine agonist that works on the nervous system to help treat the symptoms of Parkinson disease.

Pramipexole is also used to treat 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.

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 is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sulpiride

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Haloperidol
• Metoclopramide
• Olanzapine
• Risperidone

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 with muscle control) or
• Hallucinations or
• Hypotension (low blood pressure) or
• Postural hypotension (lightheadedness or fainting when getting up suddenly from a lying or sitting position)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Sleep disorders or
• Sleepiness, history of—May cause side effects to become worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Read the patient information leaflet carefully before you take this medicine. Talk to 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 tablet 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 tablets):
  • For Parkinson disease:
    • Adults—At first, 0.375 milligram (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 disease:
    • Adults—At first, 0.125 milligram (mg) 3 times 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 Restless Legs Syndrome:
    • Adults—At first, 0.125 milligram (mg) once a day 2 to 3 hours before bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 0.5 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose with the extended-release tablets and it is less than 12 hours since your regular time, take it as soon as you can and take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your regular time, skip the missed dose and take your next dose at the normal time.

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 for changes in your dose and to check for any unwanted effects.

Do not change your dose or 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 it completely. Stopping this medicine suddenly may cause anxiety, discouragement, feeling sad or empty, irritability, lack of appetite, lack of feeling or emotion, loss of interest or pleasure, sweating, tiredness, trouble concentrating, trouble sleeping, uncaring, or unusual tiredness or weakness.

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. 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.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). 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. .

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly 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 have this problem, talk to 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.

This medicine may cause posture changes that you cannot control. Tell your doctor right away if you have your neck bending forward, bending forward at the waist, or tilting sideways when you sit, stand, or walk.

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 (muscle disease that can lead to kidney problems).

Some people who have used this medicine had unusual changes in their thoughts or behavior, including an urge to gamble, spend money, binge eat, or an increased sex drive. Talk with your doctor if this is a concern for you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 suddenly from a sitting/lying position

drowsiness

nausea

seeing, hearing, or feeling things that are not there

trouble sleeping

twitching, twisting, or other unusual body movements

unusual tiredness or weakness

Less common

Chest tightness

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

swelling of the body

trouble breathing

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

swelling of the arms or legs

Incidence not known

Discouragement

feeling sad or empty

lack of appetite

lack of feeling or emotion

loss of interest or pleasure

sweating

trouble concentrating

uncaring

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

joint pain

loss of appetite

runny nose

skin rash, 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.