Mirapex ER 0.75mg Tablets
It is used to treat Parkinson's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-Parkinson's agent
Pharmacologic Class
Non-ergoline dopamine agonist
Pregnancy Category
Category C
FDA Approved
Aug 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 usually 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 the 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're feeling well.
When taking the medication, swallow the tablet whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store the 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 local drug take-back programs.
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 schedule. Do not take two doses at the same time or take extra doses. If you miss taking the medication for several days in a row, contact your doctor before restarting the medication.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the 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're feeling well.
When taking the medication, swallow the tablet whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
Store the 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 local drug take-back programs.
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 schedule. Do not take two doses at the same time or take extra doses. If you miss taking the medication for several days in a row, contact your doctor before restarting the medication.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or divide it.
- Take at approximately the same time each day, with or without food.
- Be cautious when standing up quickly from a sitting or lying position to avoid dizziness or fainting (orthostatic hypotension).
- Avoid or limit alcohol consumption, as it can increase drowsiness.
- Do not drive or operate heavy machinery until you know how this medication affects you, especially if you experience drowsiness or sudden sleep attacks.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor immediately.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initial 0.375 mg once daily, titrated weekly by 0.375 mg increments to a target dose. The 0.75 mg strength is a common titration step or maintenance dose.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial 0.375 mg once daily, titrated weekly in 0.375 mg increments to a maximum of 4.5 mg/day. Doses should be taken at approximately the same time each day with or without food. Do not crush, chew, or divide tablets.
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 every other day. Max dose 2.25 mg/day.
Moderate:
CrCl 15-29 mL/min: Initial 0.375 mg every other day. Max dose 1.5 mg/day.
Severe:
CrCl <15 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-ergoline dopamine agonist with high affinity and selectivity for the dopamine D2 subfamily of receptors, particularly D3 receptors. It is thought to exert its therapeutic effects by stimulating dopamine receptors in the striatum.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
Approximately 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:
Approximately 400 L
ProteinBinding:
Approximately 15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8-12 hours (increases with age and renal impairment)
Clearance:
Approximately 300 mL/min (renal clearance)
ExcretionRoute:
Primarily renal
Unchanged:
Approximately 90% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration and ER formulation)
PeakEffect:
Sustained plasma concentrations with once-daily dosing
DurationOfAction:
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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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, including falling asleep while driving, eating, or talking. If this happens to you, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
In rare cases, people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways while sitting, standing, or walking. 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, 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
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor 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 immediately or seek emergency medical attention:
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, including falling asleep while driving, eating, or talking. If this happens to you, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
In rare cases, people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways while sitting, standing, or walking. 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, 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
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor 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:
- Severe dizziness or fainting spells
- Sudden onset of sleep during daily activities
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, compulsive shopping, binge eating)
- Uncontrolled, involuntary movements (dyskinesia)
- New or worsening swelling in the legs or ankles
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or dark urine)
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 another medication that contains 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 whether it is safe to take this medication in conjunction 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 and the effectiveness of your treatment plan.
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 another medication that contains 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 whether it is safe to take this medication in conjunction 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 and the effectiveness of your treatment plan.
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 exercise caution when climbing stairs.
Monitor your blood pressure as directed by your healthcare provider. 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. 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, insomnia, sweating, or pain.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications 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, plan to become pregnant, or are breastfeeding, inform your doctor. You and your healthcare provider will need to discuss the potential benefits and risks of this medication to both 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 exercise caution when climbing stairs.
Monitor your blood pressure as directed by your healthcare provider. 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. 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, insomnia, sweating, or pain.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications 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, plan to become pregnant, or are breastfeeding, inform your doctor. You and your healthcare provider will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Somnolence
- Orthostatic hypotension
- Dyskinesia
- Agitation
- Confusion
- Hallucinations
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 monitoring of vital signs and observation, are recommended. Dialysis is not expected to be effective. Call 1-800-222-1222 (Poison Control Center) immediately for advice.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
- Cimetidine, Quinine, Ranitidine, Diltiazem, Triamterene, Verapamil, Quinidine: May decrease the renal clearance of pramipexole, leading to increased plasma levels.
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 (supine and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation of therapy
Psychiatric history (e.g., psychosis, impulse control disorders)
Rationale: To identify predisposition to psychiatric adverse events.
Timing: Prior to initiation of therapy
Ophthalmologic examination
Rationale: Although less common with non-ergoline agonists, baseline assessment is prudent.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood pressure (supine and standing)
Frequency: Regularly, especially during dose titration and if symptoms of orthostatic hypotension occur.
Target: Maintain within patient's normal range, minimize orthostatic drop.
Action Threshold: Significant symptomatic orthostatic hypotension (e.g., >20 mmHg systolic or >10 mmHg diastolic drop with symptoms) may require dose reduction or discontinuation.
Mental status and behavior (e.g., hallucinations, delusions, impulse control disorders, somnolence)
Frequency: At each visit, especially during dose titration.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Development of new or worsening hallucinations, psychosis, or impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) requires dose reduction or discontinuation.
Motor symptoms of Parkinson's Disease
Frequency: At each visit.
Target: Improvement in motor symptoms without excessive dyskinesia.
Action Threshold: Worsening symptoms or development of troublesome dyskinesia may require dose adjustment or addition of other therapies.
Sleep patterns (e.g., sudden onset of sleep)
Frequency: At each visit.
Target: Absence of sudden sleep attacks.
Action Threshold: Reported episodes of sudden sleep onset require counseling on driving/operating machinery and potential dose adjustment or discontinuation.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Hallucinations (visual, auditory, tactile)
- Delusions or paranoid ideation
- Impulse control disorders (pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness or sudden onset of sleep
- Dyskinesia (involuntary movements)
- Nausea, constipation, dry mouth
- 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:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Third Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Lactation
Pramipexole is not recommended during breastfeeding. It is known to inhibit prolactin secretion in humans, which could inhibit lactation. It is also excreted in rat milk, and potential for serious adverse reactions in breastfed infants exists.
Infant Risk:
Potential for inhibition of lactation, and unknown effects on the infant due to drug excretion in milk.
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 adjustments are necessary for elderly patients with impaired renal function. Elderly patients may also be more susceptible to adverse effects such as hallucinations and orthostatic hypotension.
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 and could lead to rapid drug release and increased side effects.
- Patients should be carefully titrated to their effective dose to minimize adverse effects, especially orthostatic hypotension and psychiatric symptoms.
- Counsel patients extensively on the risk of sudden onset of sleep and impulse control disorders. These can occur without warning and may require dose reduction or discontinuation.
- Switching from immediate-release pramipexole to extended-release should be done overnight at the same daily dose, but close monitoring for efficacy and tolerability is crucial.
- Renal function must be assessed before initiating therapy and periodically thereafter, as dose adjustments are critical for patient safety and efficacy.
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
- Anticholinergics (for tremor, e.g., trihexyphenidyl, benztropine)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.