Brand Name

Mirapex {Boehringer Ingelheim Pharmaceuticals, Inc}

Generic Name

pramipexole, pronounced pram i PEX ole

 

What is Mirapex?

Mirapex is a medication that treats symptoms of Parkinson’s disease, like muscle spasms, poor muscle control, stiffness and tremors. You may also be prescribed Mirapex to treat restless legs syndrome, which is also known as RLS.

Mirapex may also be used for purposes not described in this medication guide.

 

Key Facts About Mirapex

Mirapex has some of the same effects as a chemical produced in the body called dopamine, it acts as a neurotransmitter and helps the body communicate signals throughout the nerve cells of the brain. Low levels of dopamine in your brain are associated with Parkinson’s disease, and thought to be associated with RLS.

Mirapex may cause an increase in sexual urges, unusual urges to gamble or other intense urges. While it is not definite that Mirapex may be responsible for these urges you should tell your doctor immediately if you believe that you have any intense or unusual urges while taking this medication.

Taking Mirapex may make you unusually drowsy or cause you to fall asleep during normal daytime activities like working, talking, eating or driving. You may even be able to fall asleep suddenly, even just after being alert. You should tell your doctor if you have any of these problems with daytime sleepiness or drowsiness.

You should not stop taking Mirapex without talking to your doctor. Tell your doctor if you want to stop taking Mirapex and he or she will gradually taper you off of this medication

Mirapex may cause you to experience hallucinations, or the sensation of hearing or seeing something that is not there. This is more common in elderly people. Tell your doctor if you experience hallucinations.

PREGNANCY/BREASTFEEDING: Mirapex should be used with caution in pregnancy. It is not known whether Mirapex will do harm to an unborn baby. If you become pregnant while taking Mirapex do not suddenly stop taking your medication. Tell your doctor immediately and he or she will help you to safely stop taking Mirapex.

Mirapex is not known to pass into breast milk, but you should not breast-feed while taking Mirapex without talking to your doctor first. Mirapex may also reduce breast milk production.

Some patients who take Mirapex and other medications for Parkinson’s disease have developed skin cancer of the melanoma type. However, it is not determined if people with Parkinson’s disease have a higher risk than most people for developing melanoma, or if the medications relate to this finding. You should talk to your doctor about your individual risks for melanoma, as well as what skin symptoms to watch for. You should continue having regular skin exams while taking Mirapex.

 

Before You Take Mirapex

If you are allergic to pramipexole you should not take Mirapex.

If you have high or low blood pressure, heart disease, kidney disease or tremors you should tell your doctor before taking Mirapex.

If you have a history of mental illness or compulsive behaviors you should tell your doctor before starting treatment with Mirapex.

Be aware that Mirapex may cause your reaction time to be impaired. Take care to have someone with you when you are driving and first start taking Mirapex, until you know how you will react to this medication.

Mirapex may make you feel dizzy, so you should take care to steady yourself before getting up from a lying or sitting position to prevent falling.

You should not drink alcohol while taking Mirapex as it can exacerbate the side effects of this medication.

 

Mirapex Drug Interactions

You should inform your doctor if you are taking any of the following:

• Propoxyphene
• amantadine (Symmetrel)
• cimetidine (Tagamet)
• diltiazem (Cardizem, Cartia, Dilacor, Tiazac)
• nausea and vomiting medications like such metoclopramide (Reglan, Metozolv) or promethazine (Pentazine, Phenergan, Anergan, Antinaus)
• psychiatric disorder medications like chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), thiothixene (Navane) and thioridazine (Mellaril)
• quinidine (Quin-G)
• quinine (Qualaquin)
• triamterene (Dyrenium)
• verapamil (Calan, Covera, Isoptin)

Other drugs you take that are not listed may interact with Mirapex. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

 

Directions for Taking Mirapex

You should take Mirapex exactly your doctor has told you to. It is important that you do not take Mirapex in larger or smaller amounts, or for longer or shorter than recommended. Follow the directions on your prescription label and follow any dose changes carefully if your doctor instructs you to change your dose.

You can take Mirapex with or without food. Taking Mirapex with food may help to prevent nausea, which is a common side effect of this medication.

The dosage and timing of using Mirapex in treating patients with Parkinson’s disease is different from the dosage and timing in treating patients with RLS.

You should store Mirapex at room temperature away from moisture and heat.

If you miss a dose of Mirapex you should attempt to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, or if your next dose is less than 12 hours away you should skip the dose you missed.

 

Mirapex Side Effects

Seek immediate emergency medical assistance if you experience any of the following adverse effects:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips, tongue or throat 

Stop taking Mirapex and contact your physician if you experience:

• extreme drowsiness and falling asleep suddenly, even after being alert
• faint feeling and light-headedness
• fast or uneven heartbeats
• fever and flu symptoms with muscle pain, tenderness and weakness and dark colored urine
• hallucinations
• stiff muscles
• sweating and confusion
• tightness in your chest and trouble breathing
• tremors
• twitching or uncontrollable movements of your arms, eyes, face, legs, lips or tongue
• weakness
• weight loss and loss of appetite

Less serious side effects of Mirapex for adults and children may include

• agitation
• amnesia, forgetfulness and thought problems
• appetite or weight changes
• blurred vision
• constipation
• dizziness or spinning sensation
• dreams that are unusual
• drowsiness
• dry mouth
• headache
• insomnia
• sexual problems including loss of interest and impotence
• swelling in your feet and hands
• upset stomach or stomach pain
• vomiting
• worsening of RLS symptoms in the morning

It should be noted that this is not a complete list of possible side effects of Mirapex. You should contact your physician for a complete list and medical advice regarding these effects.

 

Mirapex Description and Dosing

Mirapex is available in tablet form in the following strengths:

0.125 mg which is white, round and has “BI” on one side and “83” on the reverse side.

0.25 mg which is white, oval, scored and has “BI BI” on one side and “84 84” on the reverse side.

0.5 mg which is white, oval, scored and has “BI BI” on one side and “85 85” on the reverse side.

0.75 mg which is white, oval and debossed with “BI” on one side and “101” on the reverse side.

1 mg which is white, round, scored and has “BI BI” on one side and “90 90” on the reverse side.

1.5 mg which is white, round, scored and has “BI BI” on one side and “91 91” on the reverse side.

Dosing of Mirapex is individualized based on individual patient needs. Your doctor will tell you what the appropriate dose of Mirapex is for you. Do not attempt to alter or change your dose without your physician’s consent.

If you suspect that you have overdosed with Mirapex you should seek emergency help immediately.

 

Ingredients in Mirapex

The main, active ingredient in Mirapex is pramipexole dihydrochloride monohydrate.

Inactive ingredients include mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.

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