Mirapex ER 3mg Tablets
It is used to treat Parkinson's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-Parkinson Agent
Pharmacologic Class
Dopamine Agonist, Non-Ergot
Pregnancy Category
Category C
FDA Approved
May 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pramipexole extended-release 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 extended-release form means it's released slowly over time, so you only take it once a day.
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 it causes stomach upset, take it with food to help minimize this side effect. Continue taking your medication even if you feel well, as instructed by your doctor or healthcare provider. It's essential to swallow the medication whole, without chewing, breaking, or crushing 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. 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 explore drug take-back programs in your area.
Missing 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 regimen.
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 it causes stomach upset, take it with food to help minimize this side effect. Continue taking your medication even if you feel well, as instructed by your doctor or healthcare provider. It's essential to swallow the medication whole, without chewing, breaking, or crushing 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. 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 explore drug take-back programs in your area.
Missing 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 regimen.
Lifestyle & Tips
- Take Mirapex ER once daily with or without food, at approximately the same time each day.
- Swallow the tablet whole; do not chew, crush, or divide it, as this will affect the extended-release properties.
- Be aware that this medication can cause drowsiness or sudden sleep attacks. Avoid driving or operating heavy machinery until you know how it affects you.
- Rise slowly from a sitting or lying position to minimize dizziness or lightheadedness due to a drop in blood pressure (orthostatic hypotension).
- Avoid alcohol and other sedating medications, as they can increase drowsiness.
- Report any new or unusual urges or behaviors, such as gambling, increased sexual urges, compulsive shopping, or binge eating, to your doctor immediately.
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.
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/week to target 1.5 mg/day. Max 4.5 mg/day.
Parkinson's Disease (Advanced):
Initial 0.375 mg once daily; increase by 0.375 mg/week to target 1.5 mg/day. Max 4.5 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: Initial 0.26 mg once daily. Max 2.25 mg/day.
Moderate:
CrCl 30-49 mL/min: Initial 0.18 mg once daily. Max 1.5 mg/day.
Severe:
CrCl <30 mL/min: Not recommended.
Dialysis:
Not recommended (Pramipexole is dialyzable, but specific dosing not established for ER formulation).
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 D2 subfamily dopamine receptors (D2, D3, D4), with highest affinity for D3 receptors. It is thought to exert its therapeutic effects by stimulating dopamine receptors in the striatum.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
6 hours (range 2-12 hours)
FoodEffect:
Food does not affect the extent of absorption but may decrease Cmax by approximately 20% and delay Tmax by 2 hours.
Distribution:
Vd:
Approximately 500 L
ProteinBinding:
Approximately 15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8-12 hours (increases with age and renal impairment)
Clearance:
Approximately 400 mL/min (renal clearance)
ExcretionRoute:
Primarily renal (urine)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Gradual, over several weeks of titration.
PeakEffect:
Achieved after several weeks of dose titration to an effective maintenance dose.
DurationOfAction:
Approximately 24 hours (due to extended-release 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 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 passing urine
New or worsening mental, mood, or behavioral changes
Sudden Sleepiness: A Rare but Serious Side Effect
Some people have experienced sudden sleepiness 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, do not drive or engage in activities that require alertness. Contact your doctor immediately.
Changes in Posture: A Rare but Potential Side Effect
Some people have experienced changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways, which 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): A Rare but Life-Threatening Condition
NMS is a severe and potentially deadly 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
While many people do not experience side effects or only have mild ones, it is essential to be aware of the following potential side effects:
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
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for advice. 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 passing urine
New or worsening mental, mood, or behavioral changes
Sudden Sleepiness: A Rare but Serious Side Effect
Some people have experienced sudden sleepiness 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, do not drive or engage in activities that require alertness. Contact your doctor immediately.
Changes in Posture: A Rare but Potential Side Effect
Some people have experienced changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways, which 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): A Rare but Life-Threatening Condition
NMS is a severe and potentially deadly 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
While many people do not experience side effects or only have mild ones, it is essential to be aware of the following potential side effects:
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
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for advice. 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:
- Severe dizziness or fainting spells
- Sudden onset of sleep during daily activities
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, compulsive shopping, binge eating)
- Uncontrolled, involuntary movements (dyskinesia)
- Swelling in the ankles or feet
- New or worsening nausea or constipation
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 interactions or duplicate dosing.
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 interactions or duplicate dosing.
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 performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
Follow your doctor's instructions for monitoring your blood pressure. 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 your doctor's guidance on how to taper off safely. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor.
If you notice what appears to be a tablet in your stool, discuss this with your doctor.
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, inform your doctor to discuss the potential benefits and risks to you and your baby.
When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
Follow your doctor's instructions for monitoring your blood pressure. 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 your doctor's guidance on how to taper off safely. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor.
If you notice what appears to be a tablet in your stool, discuss this with your doctor.
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, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Hyperkinesia (excessive movement)
- Hallucinations
- Agitation
- Hypotension
- Sedation
What to Do:
There is no known antidote for pramipexole overdose. Treatment should be symptomatic and supportive. Gastric lavage may be indicated if ingestion is recent. General supportive measures, including intravenous fluids and antiemetics, should be considered. Monitor vital signs. Dialysis is not effective in removing pramipexole. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the efficacy of pramipexole.
- Cimetidine, Ranitidine, Diltiazem, Quinidine, Quinine, Verapamil: May decrease the renal clearance of pramipexole, leading to increased plasma levels.
Moderate Interactions
- Sedatives, Alcohol, other CNS depressants: May potentiate the sedative effects of pramipexole.
- Levodopa: May increase the risk of dyskinesia and hallucinations 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 (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation of therapy.
Mental status/Psychiatric history
Rationale: To assess for baseline risk of hallucinations, delusions, or impulse control disorders.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure (orthostatic)
Frequency: Periodically, especially during dose titration.
Target: Maintain stable blood pressure, minimize orthostatic drops.
Action Threshold: Symptomatic orthostatic hypotension or significant drop (>20 mmHg systolic, >10 mmHg diastolic) warrants dose reduction or discontinuation.
Mental status/Behavioral changes (e.g., hallucinations, delusions, impulse control disorders)
Frequency: At each visit, or as symptoms arise.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: New onset or worsening of these symptoms warrants dose reduction, discontinuation, or psychiatric evaluation.
Sleepiness/Sudden onset of sleep
Frequency: At each visit.
Target: Maintain alertness during daily activities.
Action Threshold: Excessive daytime sleepiness or 'sleep attacks' warrants dose reduction, discontinuation, or counseling against driving/operating machinery.
Motor symptoms of Parkinson's Disease
Frequency: At each visit.
Target: Improvement in motor symptoms without excessive dyskinesia.
Action Threshold: Lack of efficacy or intolerable dyskinesia may require dose adjustment or alternative therapy.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness upon standing)
- Hallucinations (seeing or hearing things that are not there)
- Delusions (false beliefs)
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness or sudden onset of sleep
- Dyskinesia (involuntary movements)
- Nausea, constipation
- Peripheral edema
Special Patient Groups
Pregnancy
Pramipexole is classified as 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:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Limited human data; animal studies suggest potential for adverse effects on offspring development.
Third Trimester:
Limited human data; animal studies suggest potential for adverse effects on offspring development.
Lactation
Pramipexole is known to inhibit prolactin secretion in humans, which could 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:
Risk level L3 (Moderately Safe) - but generally not recommended due to potential for inhibiting lactation and unknown infant effects. Potential for CNS effects in infant.
Pediatric Use
The safety and effectiveness of pramipexole in pediatric patients have not been established for Parkinson's disease or restless legs syndrome. Use is not recommended.
Geriatric Use
Elderly patients (âĨ65 years) have reduced renal clearance of pramipexole, leading to higher plasma concentrations and a longer half-life. Dose adjustments are often necessary based on renal function. Elderly patients may also be at increased risk for hallucinations and orthostatic hypotension.
Clinical Information
Clinical Pearls
- Mirapex ER is designed for once-daily dosing. Emphasize that patients should not crush, chew, or divide the tablets.
- Counsel patients about the potential for sudden onset of sleep and orthostatic hypotension, especially during dose titration. Advise caution with driving or operating machinery.
- Educate patients and caregivers about the risk of impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and to report any new or unusual behaviors immediately.
- Titrate the dose slowly to minimize adverse effects and optimize therapeutic benefit.
- Monitor renal function, especially in elderly patients, as dose adjustments are crucial for safety and efficacy.
- Hallucinations are a common side effect, particularly in advanced Parkinson's disease and in the elderly. Dose reduction or discontinuation may be necessary.
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine transdermal system)
- Levodopa/carbidopa (e.g., Sinemet, Rytary, Duopa)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- Istradefylline
Cost & Coverage
Average Cost:
Varies widely (e.g., $300-$800+) 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's 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 be sure to check with your pharmacist for more information. 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.