Mirapex ER 3.75mg 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. This extended-release form is taken once a day to provide a steady effect.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well.
When taking your medication, swallow the tablet whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 the missed dose 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 regimen.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well.
When taking your medication, swallow the tablet whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 the missed dose 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 regimen.
Lifestyle & Tips
- Take Mirapex ER once daily with or without food. Swallow the tablet whole; do not crush, chew, or divide it.
- Avoid alcohol or other sedating medications, as they can increase drowsiness.
- Be cautious when driving or operating machinery, especially when starting treatment or increasing the dose, due to the risk of sudden sleep attacks or dizziness.
- Stand up slowly from a sitting or lying position to reduce the risk of dizziness or fainting due to low blood pressure.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 0.375 mg orally once daily. Titrate weekly in 0.375 mg increments to a maximum of 4.5 mg once daily.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease (Early):
Initial: 0.375 mg once daily. Titrate weekly by 0.375 mg increments to a target dose of 1.5 mg once daily. Max: 4.5 mg once daily.
Parkinson's Disease (Advanced):
Initial: 0.375 mg once daily. Titrate weekly by 0.375 mg increments. Max: 4.5 mg once daily.
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 0.375 mg once daily. Max 2.25 mg once daily.
Moderate:
CrCl 15-29 mL/min: Initial 0.375 mg every other day. Max 1.5 mg once daily.
Severe:
CrCl <15 mL/min: Not recommended due to insufficient data. Consider alternative therapies or very careful titration with close monitoring.
Dialysis:
Not studied. Avoid use or use with extreme caution and close monitoring, as pramipexole is significantly renally cleared.
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 the D2 subfamily of dopamine receptors, particularly D2 and D3 receptor subtypes. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum, thereby mimicking the effects of dopamine and improving motor symptoms associated with Parkinson's disease.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
6 hours (for ER formulation)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be prolonged by approximately 2 hours.
Distribution:
Vd:
400 L
ProteinBinding:
~15%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-12 hours (increases with renal impairment)
Clearance:
Approximately 400 mL/min (primarily renal)
ExcretionRoute:
Renal (urine)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Gradual (titration required)
PeakEffect:
Prolonged (due to extended-release formulation)
DurationOfAction:
24 hours (once daily dosing)
Safety & Warnings
Side Effects
Serious 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 experience 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 urinating
New or worsening mental, mood, or behavioral changes
Important Safety Information
Some people taking this medication have fallen asleep suddenly during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.
Additionally, some people have experienced uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when sitting, standing, or walking. These changes can 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)
NMS 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 Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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 experience 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 urinating
New or worsening mental, mood, or behavioral changes
Important Safety Information
Some people taking this medication have fallen asleep suddenly during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.
Additionally, some people have experienced uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when sitting, standing, or walking. These changes can 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)
NMS 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 Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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 (e.g., driving, eating)
- Dizziness, lightheadedness, or fainting, especially when standing up
- Seeing, hearing, or feeling things that are not real (hallucinations)
- Unusual urges or behaviors, such as gambling, increased sexual urges, compulsive shopping, or binge eating
- Uncontrolled, involuntary movements (dyskinesia)
- Swelling in the legs or ankles (peripheral edema)
- Nausea or constipation that is severe or persistent
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
* If you are currently taking another medication that contains the same active ingredient as this drug.
This list is not exhaustive, and it is crucial to discuss all 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 with your existing 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
* If you are currently taking another medication that contains the same active ingredient as this drug.
This list is not exhaustive, and it is crucial to discuss all 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 with your existing 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 and increase the risk of adverse effects. Additionally, consult your doctor before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness or impair your ability to perform tasks.
If you notice what appears to be a tablet in your stool, consult your doctor to determine the cause and appropriate course of action.
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, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible 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 and increase the risk of adverse effects. Additionally, consult your doctor before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness or impair your ability to perform tasks.
If you notice what appears to be a tablet in your stool, consult your doctor to determine the cause and appropriate course of action.
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, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Drowsiness
- Orthostatic hypotension
- Dyskinesia
- Agitation
- Confusion
- Hallucinations
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. There is no specific antidote; treatment is supportive.
Drug Interactions
Major Interactions
- Dopamine Antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
- CNS Depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of pramipexole.
Moderate Interactions
- Cimetidine: May decrease renal clearance of pramipexole, leading to increased plasma levels.
- Amantadine: Concomitant use may increase the risk of hallucinations and confusion.
- Levodopa: May increase the risk of dyskinesia when co-administered with pramipexole.
Monitoring
Baseline Monitoring
Renal Function (CrCl)
Rationale: Pramipexole is primarily renally eliminated; dose adjustments are necessary in renal impairment.
Timing: Prior to initiation of therapy
Blood Pressure (Orthostatic)
Rationale: Risk of orthostatic hypotension, especially during titration.
Timing: Prior to initiation and during titration
Psychiatric History
Rationale: Assess for pre-existing psychosis, hallucinations, or impulse control disorders, which can be exacerbated.
Timing: Prior to initiation of therapy
Ophthalmologic Exam
Rationale: Although rare, retinal changes have been observed in animal studies; baseline and periodic exams may be considered.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood Pressure (Orthostatic)
Frequency: Regularly, especially during dose titration and if symptoms occur.
Target: Maintain stable blood pressure, minimize orthostatic drops.
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope); significant drop in SBP (>20 mmHg) or DBP (>10 mmHg) upon standing.
Mental Status (Hallucinations, Psychosis, Impulse Control Disorders)
Frequency: At each visit, or as clinically indicated.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Development of hallucinations, delusions, paranoia, or new/worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating).
Motor Symptoms (Parkinson's Disease)
Frequency: At each visit.
Target: Improvement in motor symptoms (e.g., tremor, rigidity, bradykinesia) without excessive dyskinesia.
Action Threshold: Worsening of motor symptoms, development of severe dyskinesia, or motor fluctuations.
Sleep Patterns (Somnolence, Sudden Sleep Attacks)
Frequency: At each visit, or as clinically indicated.
Target: Maintain normal wakefulness during daily activities.
Action Threshold: Excessive daytime sleepiness, sudden onset of sleep during activities of daily living.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Hallucinations (visual, auditory, tactile)
- Delusions or paranoia
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness or sudden sleep attacks
- Dyskinesia (involuntary movements)
- Nausea, constipation
- Peripheral edema
Special Patient Groups
Pregnancy
Pramipexole is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies showed developmental toxicity (e.g., skeletal abnormalities) at doses higher than human therapeutic doses. Risk in humans is unknown.
Second Trimester:
Risk of dopamine agonist effects on fetal development is not well-established.
Third Trimester:
May inhibit prolactin secretion, potentially affecting lactation post-delivery.
Lactation
Pramipexole is excreted in rat milk and is known to inhibit prolactin secretion in humans, which may inhibit lactation. It is not known if pramipexole is excreted in human milk. 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 serious adverse reactions in a breastfed infant (e.g., CNS effects, inhibition of growth). Risk is considered L3 (Moderately Safe - likely to decrease milk production).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for Parkinson's disease. Not indicated for use in pediatric populations for this condition.
Geriatric Use
No overall differences in effectiveness were observed between elderly and younger patients, but older patients may be more sensitive to the adverse effects (e.g., hallucinations, orthostatic hypotension) and are more likely to have decreased renal function, requiring dose adjustment.
Clinical Information
Clinical Pearls
- Mirapex ER is designed for once-daily dosing and should not be crushed, chewed, or divided, as this will alter its extended-release properties.
- Patients should be warned about the potential for sudden onset of sleep and advised to avoid driving or operating machinery if they experience somnolence.
- Educate patients and caregivers about the risk of impulse control disorders and other psychiatric side effects, as patients may not recognize these changes themselves.
- Titrate the dose slowly to minimize side effects, especially orthostatic hypotension and nausea.
- Renal function must be assessed before initiating therapy and monitored periodically, with dose adjustments made as necessary.
Alternative Therapies
- Other Dopamine Agonists (e.g., Ropinirole ER, Rotigotine transdermal system)
- Levodopa/Carbidopa (e.g., Sinemet, Rytary, Duopa)
- MAO-B Inhibitors (e.g., Selegiline, Rasagiline, Safinamide)
- COMT Inhibitors (e.g., Entacapone, Tolcapone, Opicapone)
- Amantadine
- Anticholinergics (for tremor, e.g., Benztropine, Trihexyphenidyl)
Cost & Coverage
Average Cost:
Check current per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.