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|Mirapex

PRAMIPEXOLE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Mirapex

In Canada—

• Mirapex

Category

• Antidyskinetic (dopamine agonist)

Description

Pramipexole (pra-mi-PEX-ole) is used to treat Parkinson"s disease. It may be used alone, or in combination with levodopa or other medicines to treat this disease.

This medicine is available only with your doctor"s prescription, in the following dosage form(s):

• Oral
• Tablets (U.S. and Canada)

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 pramipexole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pramipexole. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Pramipexole has not been studied in pregnant women. However, studies in pregnant animals have shown that pramipexole may interfere with the pregnancy when the mother is given doses many times higher than the human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether pramipexole passes into breast milk. Because of the possibility of serious unwanted effects in the nursing infant, it is important that you discuss the use of this medicine with your doctor if you wish to breast-feed.

Children—Studies on this medicine 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.

Older adults—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.

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 pramipexole, it is especially important that your health care professional know if you are taking any of the following:

• Carbidopa and levodopa combination (e.g., Sinemet) or
• Levodopa (e.g., Dopar, Larodopa)—Pramipexole may cause an increase in the side effects of levodopa; your doctor may need to adjust your dosage

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

• 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 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 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 number of tablets 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 your medical condition .

• For oral dosage form (tablets):
  • For Parkinson"s disease:
    • Adults—At first, 0.125 milligrams (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.

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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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 this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

This medicine 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 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.

Patients receiving this medicine 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 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.

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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Revised: 01/13/2000

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