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Parkinson's Disease HOL-emblem1-web.GIF (3556 bytes)

Pramipexole

BRAND: Mirapex

Pramipexole is a non-ergot D2/D3 agonist. It is a synthetic amino-benzathiazol derivative. Side effects are similar to other dopamine agonists and include somnolence, nausea, constipation, insomnia, and hallucinations. Somnolence may be more common than with other dopaminergic medications and may necessitate dose reduction or discontinuation. Ergot-related pleural and retroperitoneal fibrosis have not been reported.

Pramipexole is effective both as early monotherapy and as an adjunct to treatment with levodopa. In a six month trial comparing pramipexole to placebo as add-on therapy in patients with motor fluctuations on levodopa, "off" time was reduced by 17% in pramipexole-treated patients compared with 8% in placebo-treated patients. Levodopa was reduced by 25% in the pramipexole group compared with 6% in the placebo group. Pramipexole significantly improved motor function in both the "on" and "off" states. In a comparison of pramipexole to placebo as monotherapy in early disease, pramipexole significantly improved motor function.

Pramipexole can be taken with or without food. Food may lessen nausea or stomach upset. Pramipexole is usually started at low doses and increased gradually. Follow your doctor's instructions. It may be several weeks or months before the benefits of pramipexole are seen. Continue to take the medication until your doctor recommends that you stop.

Important information About Pramipexole
bulletUse caution when driving, operating machinery, or performing other hazardous activities. Pramipexole may cause drowsiness, dizziness, or falling asleep while performing activities of daily living, sometimes without warning . If you experience increased drowsiness or dizziness, or episodes of falling asleep while performing activities of daily living (e.g., watching television, riding in a car, etc.), do not drive or participate in potentially dangerous activities and contact your doctor.
bulletDizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly and use caution to prevent a fall.
bulletAlcohol, sleep aids, antihistamines, antidepressants, antipsychotics, and other medicines that cause drowsiness may increase the drowsiness caused by pramipexole, which could be dangerous. Do not use alcohol or take other medicines without first talking to your doctor.
bulletHallucinations may occur with pramipexole, and may be more common in elderly patients. Call your doctor if you experience hallucinations.

Do Not Take Pramipexole If
bulletBefore taking this medication, tell your doctor if you have kidney disease. You may require a lower dose or special monitoring during therapy with pramipexole.
bulletPramipexole is in the FDA pregnancy category C. This means that it is not known whether pramipexole will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.
bulletIt is also not known whether pramipexole passes into breast milk. Pramipexole may reduce breast milk production. Do not take pramipexole without first talking to your doctor if you are breast-feeding a baby.
bulletHallucinations may be more likely to occur in patients older than 65 years of age.

Drug Overdose

Seek emergency medical attention if you take an overdose.

Symptoms of a pramipexole overdose are not known but might include nausea, vomiting, weakness, dizziness, fainting, agitation, confusion, hallucinations, muscle twitching, uncontrollable movements, a tingling sensation, and chest pain.

Avoid while Taking Pramipexole
bulletUse caution when driving, operating machinery, or performing other hazardous activities. Pramipexole may cause drowsiness, dizziness, or falling asleep while performing activities of daily living, sometimes without warning . If you experience increased drowsiness or dizziness, or episodes of falling asleep while performing activities of daily living (e.g., watching television, riding in a car, etc.), do not drive or participate in potentially dangerous activities and contact your doctor.
bulletDizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly and use caution to prevent a fall.
bulletAlcohol, sleep aids, antihistamines, antidepressants, antipsychotics, and other medicines that cause drowsiness may increase the drowsiness caused by pramipexole. Do not take other medicines without first talking to your doctor.

Side Effects of Pramipexole
bulletStop taking pramipexole and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
bulletNotify your doctor immediately if you experience hallucinations, fainting, dizziness, drowsiness, falling asleep unexpectedly, or a blackout (especially when rising from a sitting or lying position). Your doctor may want to lower your dosage or discontinue this medication.

Continue to take pramipexole and talk to your doctor if you experience the following minor side effects.
bulletMild nausea
bulletVomiting
bulletUpset stomach
bulletDecreased appetite
bulletConstipation
bulletDry mouth
bulletSweating
bulletHeadache
bulletConfusion
bulletInsomnia
bulletAgitation or anxiety

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Drug Interactions

Before taking pramipexole, tell your doctor if you are taking any of the following medicines:
bulletThe stomach medicines cimetidine (Tagamet, Tagamet HB), ranitidine (Zantac, Zantac 75), or metoclopramide (Reglan);
bulletThe heart medicines diltiazem (Cardizem, Dilacor XR, Tiazac), verapamil (Verelan, Calan), triamterene (Dyrenium, Dyazide, Maxzide), or quinidine (Quinaglute, Cardioquin, Quinidex, others);
bulletThe malaria and leg cramp medicine quinine (Quinamm); or
bulletA medication used to treat mania, schizophrenia, other psychiatric conditions, and nausea and vomiting, such as Chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), thioridazine (Mellaril), promazine (Sparine), trifluoperazine (Stelazine), thiothixene (Navane), haloperidol (Haldol), and others.
bulletYou may require special monitoring or a dosage adjustment if you are taking any of the medicines listed above.
bulletPramipexole may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pramipexole is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Other drugs may also interact with pramipexole. Do not take any other prescription or over-the-counter medicines or herbs without the approval of your doctor.

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