- What is pramipexole?
- Important Information
- Before taking this medicine
- How should I take pramipexole?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking pramipexole?
- Pramipexole side effects
- Pramipexole dosing information
- What other drugs will affect pramipexole?
- Further information
- More about pramipexole
- Pramipexole (Mirapex) for Restless Legs Syndrome
- Pramipexole Side Effects
Generic Name: pramipexole (pram i PEX ole)
Brand Name: Mirapex, Mirapex ER
Medically reviewed by Drugs.com on Jun 11, 2018 – Written by Cerner Multum
- Side Effects
What is pramipexole?
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.
Before taking this medicine
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;
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.
How should I take pramipexole?
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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking pramipexole?
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.
Pramipexole side effects
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.
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 this medicine. Talk with your doctor if this occurs.
Common side effects may include:
muscle spasm or muscle weakness;
drowsiness, dizziness, weakness;
confusion, memory problems;
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.
Pramipexole dosing information
Usual Adult Dose for Parkinson’s Disease:
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.
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.
-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:
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
-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.
What other drugs will affect pramipexole?
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:
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 8.01.
More about pramipexole
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- Drug class: dopaminergic antiparkinsonism agents
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- Pramipexole Tablets
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Other brands: Mirapex, Mirapex ER
- Pramipexole Dihydrochloride (AHFS Monograph)
- … +3 more
Related treatment guides
- Periodic Limb Movement Disorder
- Restless Legs Syndrome
- Tardive Dyskinesia
- Parkinson’s Disease
Before taking pramipexole,
- tell your doctor and pharmacist if you are allergic to pramipexole or any other medications, or any of the ingredients in pramipexole tablets or extended- release tablets.Ask your doctor or pharmacist for a list of the inactive ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; cimetidine (Tagamet); medications for allergies, mental illness, and nausea; metoclopramide (Reglan); sedatives; sleeping pills; and tranquilizers. . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had mental illness, trouble controlling movement of your muscles,a sleep disorder other than restless legs syndrome, dizziness, fainting, low blood pressure, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding. If you become pregnant while taking pramipexole, call your doctor.
- you should know that pramipexole may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy before you suddenly fall asleep. Do not drive a car or operate machinery at the beginning of your treatment until you know how pramipexole will affect you. If you suddenly fall asleep while you are doing something such as watching television or riding in a car, or if you become very drowsy, call your doctor. Do not drive or operate machinery until you talk to your doctor.
- you should know that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic beverages.
- you should know that pramipexole may cause dizziness, lightheadedness, nausea, fainting, or sweating when you get up too quickly from a sitting or lying position. This is more common when you first start taking pramipexole, or when your dose is increased. To avoid this problem, get out of the chair or bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that some people who took medications such as pramipexole to treat Parkinson’s disease or restless legs syndrome developed gambling problems, an increased interest in shopping or sex, overeating problems, or other intense urges or behaviors that were compulsive or unusual for them. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you develop intense urges or have difficulty controlling any of these behaviors. Tell your family members about these risks so that they can call the doctor even if you do not realize that your behavior has become a problem.
- you should know that if you are taking the extended-release tablets, you may notice something that looks like a swollen tablet or swollen pieces of tablet in your stool. If this happens, especially along with a worsening of your Parkinson’s disease symptoms, call your doctor.
Pramipexole (Mirapex) for Restless Legs Syndrome
Adverse effects occur less often with the lower doses of pramipexole used to treat RLS than with the higher doses used to treat Parkinson’s disease. Approximately 6 percent of patients with Parkinson’s disease who are treated with pramipexole have reported daytime drowsiness compared with 3 percent of those treated with placebo. Case reports have described episodes of falling asleep while engaged in normal activities, including driving. This sudden somnolence may occur up to one year after starting treatment and may not be preceded by warning signs.3 These events have only been reported by patients treated with pramipexole for Parkinson’s disease, and not by patients treated for RLS. To minimize the risk of daytime somnolence, patients should be given the lowest effective dose.3
Hallucinations, pathologic gambling and other compulsive behaviors, and orthostatic hypotension are uncommon in patients taking higher doses of pramipexole for Parkinson’s disease and are seen even less in patients taking lower doses for RLS. Pramipexole is U.S. Food and Drug Administration pregnancy category C.
Augmentation of RLS symptoms with long-term therapy occurs in approximately one fourth of patients taking pramipexole.1,4 Symptoms may begin earlier in the evening, become more severe, and spread to the arms and trunk. Rebound or recurrence of RLS symptoms in the early morning also may occur over time; one study reported an incidence of 13 percent.4 Initiating therapy earlier in the day is often effective at controlling these symptoms; however, increasing the dose may worsen augmentation, requiring alternative therapies (e.g., opioids) to attain control.
Nausea and sedation will occur in up to 30 percent of patients.1,4–6 Approximately 7 percent of patients with RLS receiving pramipexole discontinued treatment because of adverse effects compared with 5 percent of patients receiving placebo.1
In the first three months of treatment, approximately 60 percent of patients receiving pramipexole instead of placebo will have at least a 50 percent reduction in symptoms; however, there is a profound placebo effect, and 42 percent of patients receiving placebo will also report this reduction. Approximately six patients need to be treated with pramipexole instead of placebo for one additional person to have a decrease in symptoms.6,7 On average, all studied doses (0.25, 0.5, and 0.75 mg) produce the same reduction of RLS symptoms, so patients should be started on the lowest dose (0.125 mg) and only titrated to higher doses as needed.4–6 Symptoms will recur when treatment is stopped. Pramipexole has not been directly compared with any other treatments for RLS.
The approximate monthly cost of pramipexole 0.25 mg is $45; higher doses are more expensive.
The starting dosage of pramipexole is 0.125 mg taken once daily two to three hours before bedtime. If needed, the dosage may be doubled every four to seven days up to a maximal dosage of 0.5 mg daily. The duration between titration steps should be increased to 14 days in patients with a creatinine clearance of 20 to 60 mL per minute (0.33 to 1.00 mL per second).1 Pramipexole can be discontinued without tapering doses.
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Pramipexole Side Effects
Visit your doctor or health care professional for regular checks on your progress. It may be several weeks or months before you feel the full effect of this medicine. Continue to take your medicine on a regular schedule.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. If you find that you have sudden feelings of wanting to sleep during normal activities, like cooking, watching television, or while driving or riding in a car, you should contact your health care professional.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
There have been reports of increased sexual urges or other strong urges such as gambling while taking some medicines for Parkinson’s disease. If you experience any of these urges while taking this medicine, you should report it to your health care provider as soon as possible.
Talk with your doctor if you have posture changes you cannot control. These may include your neck bending forward, your spine bending forward at the waist, or tilting sideways when you sit, stand, or walk.