Mirapex ER 2.25mg Tablets
It is used to treat Parkinson's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiparkinsonian agent
Pharmacologic Class
Dopamine agonist
Pregnancy Category
Category C
FDA Approved
May 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mirapex ER is a medication used to treat Parkinson's disease. It works by acting like a natural chemical in your brain called dopamine, which helps control movement. The 'ER' means extended-release, so you take it once a day, and it releases the medicine slowly over time.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue taking your medication even if you feel well, as instructed by your doctor or healthcare provider. Swallow the medication whole; do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 12 hours or more since the missed dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue taking your medication even if you feel well, as instructed by your doctor or healthcare provider. Swallow the medication whole; do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 12 hours or more since the missed dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or divide it.
- Can be taken with or without food.
- Avoid alcohol or other sedating medications, as they can increase drowsiness.
- Be cautious when driving or operating machinery, especially when starting treatment or increasing dose, due to the risk of sudden sleep onset or dizziness.
- Stand up slowly to avoid dizziness from low blood pressure.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 0.375 mg orally once daily. Titrate gradually. Maintenance: 1.5 mg to 4.5 mg orally once daily.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease (Early):
Initial: 0.375 mg once daily. Increase by 0.375 mg every 5-7 days to a maximum of 4.5 mg/day. Typical effective dose range: 1.5 mg to 4.5 mg/day.
Parkinson's Disease (Advanced):
Initial: 0.375 mg once daily. Increase by 0.375 mg every 5-7 days to a maximum of 4.5 mg/day. Typical effective dose range: 1.5 mg to 4.5 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 30-50 mL/min: Initial dose 0.375 mg every other day. Maximum dose 2.25 mg once daily.
Moderate:
CrCl <30 mL/min: Not recommended due to insufficient data and potential for accumulation.
Severe:
CrCl <30 mL/min: Not recommended.
Dialysis:
Not recommended.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for dopamine D2 and D3 receptors. It is believed to exert its antiparkinsonian effects by stimulating dopamine receptors in the striatum.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
Approximately 6 hours (ER formulation)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be prolonged by approximately 1 hour.
Distribution:
Vd:
Approximately 400 L
ProteinBinding:
<20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8-12 hours (increases with age and renal impairment)
Clearance:
Approximately 400 mL/min (total body clearance)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
Approximately 90%
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration and ER formulation)
PeakEffect:
Not directly quantifiable as a single point for therapeutic effect, but steady-state concentrations are reached within 5-7 days of stable dosing.
DurationOfAction:
24 hours (ER formulation)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty passing urine
New or worsening mental, mood, or behavior changes
Some people have experienced sudden, uncontrollable sleepiness, even during activities like driving, eating, or talking. If this happens to you, do not drive or engage in tasks that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Additionally, some people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways. These changes may occur several months after starting the medication or after a dose increase. If you notice any changes in your posture, contact your doctor.
Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition that can occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty passing urine
New or worsening mental, mood, or behavior changes
Some people have experienced sudden, uncontrollable sleepiness, even during activities like driving, eating, or talking. If this happens to you, do not drive or engage in tasks that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Additionally, some people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways. These changes may occur several months after starting the medication or after a dose increase. If you notice any changes in your posture, contact your doctor.
Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially life-threatening condition that can occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden onset of sleep during daily activities (even without warning)
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating)
- Dizziness or fainting, especially when standing up
- Nausea or vomiting that is severe or persistent
- Uncontrolled, involuntary movements (dyskinesia)
- Swelling in the legs or ankles
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
* If you are currently taking any other medications that contain the same active ingredient as this drug, to avoid potential duplication of therapy.
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
* If you are currently taking any other medications that contain the same active ingredient as this drug, to avoid potential duplication of therapy.
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
As directed by your healthcare provider, regularly monitor your blood pressure to ensure it remains within a safe range.
Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the tapering schedule recommended by your doctor. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
Avoid consuming alcohol while taking this medication, as it may interact with the drug. Additionally, consult your doctor before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness or impair your reactions.
If you notice what appears to be a tablet in your stool, consult your doctor to determine the cause.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
As directed by your healthcare provider, regularly monitor your blood pressure to ensure it remains within a safe range.
Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the tapering schedule recommended by your doctor. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
Avoid consuming alcohol while taking this medication, as it may interact with the drug. Additionally, consult your doctor before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness or impair your reactions.
If you notice what appears to be a tablet in your stool, consult your doctor to determine the cause.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Hyperkinesia (excessive movement)
- Agitation
- Hypotension (low blood pressure)
- Hallucinations
- Confusion
- Priapism (prolonged erection)
What to Do:
There is no known antidote. Treatment is symptomatic and supportive. Gastric lavage may be indicated if ingestion is recent. Maintain vital signs. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of pramipexole.
- CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of pramipexole.
Moderate Interactions
- Drugs eliminated by renal tubular secretion (e.g., cimetidine, ranitidine, diltiazem, verapamil, quinidine, quinine): May decrease the renal clearance of pramipexole, leading to increased plasma concentrations and potential for adverse effects.
- Levodopa: May increase the incidence of dyskinesia when co-administered with pramipexole.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Pramipexole is primarily renally excreted; dose adjustment is required in renal impairment.
Timing: Prior to initiation of therapy.
Blood pressure (orthostatic)
Rationale: Risk of orthostatic hypotension, especially during dose titration.
Timing: Prior to initiation and during early titration.
Mental status/Psychiatric history
Rationale: Risk of hallucinations, psychosis, and impulse control disorders.
Timing: Prior to initiation.
Routine Monitoring
Efficacy (Parkinson's symptoms)
Frequency: Regularly during titration and maintenance
Target: Improved motor function, reduced 'off' time
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, nausea, dyskinesia, hallucinations, orthostatic hypotension, impulse control disorders)
Frequency: At each visit, especially during titration
Target: Absence or manageable level of side effects
Action Threshold: Presence of significant or intolerable side effects may require dose reduction, discontinuation, or symptomatic management.
Blood pressure (orthostatic)
Frequency: Periodically, especially if symptoms of orthostasis occur
Target: Stable blood pressure without significant orthostatic drop
Action Threshold: Symptomatic orthostatic hypotension or significant drop (>20 mmHg systolic, >10 mmHg diastolic) requires intervention.
Symptom Monitoring
- Excessive daytime sleepiness or sudden sleep onset
- Dizziness or lightheadedness (especially upon standing)
- Nausea or vomiting
- Hallucinations or confusion
- Uncontrolled urges (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Unusual changes in behavior or mood
- Muscle twitching or involuntary movements (dyskinesia)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies suggest potential for developmental toxicity at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
Pramipexole is known to inhibit prolactin secretion in humans and may inhibit lactation. It is unknown if pramipexole is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for inhibition of lactation; potential for adverse effects in the infant (e.g., CNS effects).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in pediatric populations.
Geriatric Use
Renal clearance of pramipexole decreases with age. Dose adjustment is recommended based on renal function. Elderly patients may be more susceptible to adverse effects such as hallucinations and orthostatic hypotension.
Clinical Information
Clinical Pearls
- Pramipexole ER should be swallowed whole and not crushed, chewed, or divided, as this will alter its extended-release properties.
- Titration is crucial to minimize side effects, especially orthostatic hypotension and somnolence. Patients should be counselled on the slow titration schedule.
- Counsel patients and caregivers about the risk of sudden sleep attacks and impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), which can occur with dopamine agonists.
- Hallucinations are a common side effect, especially in elderly patients or those with advanced Parkinson's disease. Dose reduction or discontinuation may be necessary.
- Monitor for orthostatic hypotension, particularly during the initial titration phase. Advise patients to rise slowly from a sitting or lying position.
- If discontinuing, pramipexole should be tapered gradually to avoid withdrawal symptoms (e.g., akinesia, anxiety, depression, fatigue, insomnia, sweating, pain).
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine, apomorphine)
- Levodopa/carbidopa (e.g., Sinemet, Rytary, Duopa)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone, tolcapone)
- Amantadine
- Anticholinergics (e.g., trihexyphenidyl, benztropine - for tremor)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.