Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Pramipexole is used to treat symptoms of Parkinson's disease (stiffness, tremors, muscle spasms, and poor muscle control). Pramipexole is also used to treat restless legs syndrome (RLS).

Only immediate-release pramipexole (Mirapex) is approved to treat either Parkinson symptoms or RLS. Extended-release pramipexole (Mirapex ER) is approved only to treat Parkinson symptoms.

Parkinson's and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.

Pramipexole may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you are taking immediate-release pramipexole (Mirapex) you should not take extended-release pramipexole (Mirapex ER) at the same time.

The dose and timing of pramipexole in treating Parkinson's disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of pramipexole you receive at the pharmacy.

Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach.

Do not crush, chew, or break an extended-release tablet (Mirapex ER). Swallow it whole.

If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Parkinson's Disease:

Immediate-release:
Initial dose: 0.125 mg orally three times a day
Titration: Increase gradually in small dose increments no more frequently than ever 5 to 7 days
Maintenance dose: 1.5 to 4.5 mg per day based on efficacy and tolerability
Maximum dose: 4.5 mg per day

Comment: The following dose titration was used in clinical trials:
Week 2, 0.25 mg 3 times a day
Week 3, 0.5 mg 3 times a day
Week 4, 0.75 mg 3 times a day
Week 5, 1 mg 3 times a day
Week 6, 1.25 mg 3 times a day
Week 7, 1.5 mg 3 times a day.
-When used in combination with levodopa, the levodopa dose was reduced by an average of 27% from baseline providing a concomitant dose of approximately 800 mg per day.

Extended-release:
Initial dose: 0.375 mg orally once a day
Titration: Increase gradually no more frequently than every 5 to 7 days, first dose increase should be to 0.75 mg once a day followed by incremental increases of 0.75 mg; assess therapeutic response and tolerability at a minimum of 5 days after each dose increase.
Maximum dose: 4.5 mg per day

SWITCHING FROM IMMEDIATE-RELEASE TO EXTENDED-RELEASE:
-Patients may be switched overnight from immediate-release tablets to extended-release tablets at the same daily dose; monitor closely to determine if dose adjustments may be necessary.

Comments:
-If a significant interruption in therapy occurs, re-titration may be necessary; upon discontinuation, doses should be tapered.

Use: Treatment of Parkinson's disease

Usual Adult Dose for Restless Legs Syndrome:

Immediate-release:
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
Titration: If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maximum dose: 0.5 mg orally once a day

Comments:
-Extended-release tablets are not indicated for Restless Legs Syndrome.
-Doses of 0.75 mg once a day were used in clinical trials, but were not found to provide additional benefit as compared to the 0.5 mg dose.

Use: For the treatment of moderate to severe primary Restless Legs Syndrome.

You should not use pramipexole if you are allergic to it.

Tell your doctor if you have ever had:

• low blood pressure;

• dizziness after getting up too fast;

• daytime drowsiness;

• kidney disease; or

• problems controlling your muscle movements.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using pramipexole.

It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store the regular tablets away from light.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects can occur when alcohol is combined with pramipexole.

Avoid driving or hazardous activity until you know how pramipexole will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Pramipexole may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• hallucinations (seeing or hearing things that are not real);

• extreme drowsiness, falling asleep suddenly, even after feeling alert;

• tremors, twitching or uncontrollable muscle movements;

• unexplained muscle pain, tenderness, or weakness;

• vision problems; or

• posture changes you cannot control, such as involuntary bending forward of your neck, bending forward at the waist, or tilting sideways when you sit, stand, or walk.

Side effects such as confusion or hallucinations may be more likely in older adults.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking pramipexole. Talk with your doctor if this occurs.

Common side effects of pramipexole may include:

• muscle spasm or muscle weakness;

• drowsiness, dizziness, weakness;

• confusion, memory problems;

• dry mouth;

• nausea, constipation;

• increased urination; or

• sleep problems (insomnia), unusual dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using pramipexole with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• cimetidine;

• metoclopramide; or

• medicine to treat mental illness, such as chlorpromazine, droperidol, fluphenazine, haloperidol, perphenazine, prochlorperazine, thioridazine, and others.

This list is not complete. Other drugs may affect pramipexole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.