Mirapex ER 4.5mg 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
Dopamine Agonist, Non-Ergot
Pregnancy Category
Category C
FDA Approved
May 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pramipexole extended-release (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. In Parkinson's disease, there isn't enough dopamine, so this medicine helps to improve symptoms like tremors, stiffness, and difficulty moving.
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 discomfort. 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 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 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 discomfort. 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 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 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.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause serious withdrawal symptoms.
- Be aware of potential side effects like dizziness or drowsiness, especially when starting the medication or increasing the dose. Avoid driving or operating machinery until you know how it affects you.
- Rise slowly from a sitting or lying position to reduce the risk of dizziness or fainting due to low blood pressure.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor immediately.
- Avoid alcohol and other sedating medications, as they can increase drowsiness.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 0.375 mg once daily, titrated gradually.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease (Early):
Initial: 0.375 mg once daily. Titrate weekly: Week 1: 0.375 mg, Week 2: 0.75 mg, Week 3: 1.5 mg, Week 4: 2.25 mg, Week 5: 3 mg, Week 6: 3.75 mg, Week 7: 4.5 mg. Max: 4.5 mg once daily.
Parkinson's Disease (Advanced, with Levodopa):
Initial: 0.375 mg once daily. Titrate weekly: Week 1: 0.375 mg, Week 2: 0.75 mg, Week 3: 1.5 mg, Week 4: 2.25 mg, Week 5: 3 mg, Week 6: 3.75 mg, Week 7: 4.5 mg. 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 50-80 mL/min: Initial 0.375 mg once daily. Max 2.25 mg once daily.
Moderate:
CrCl 30-49 mL/min: Initial 0.375 mg every other day. Max 2.25 mg once daily.
Severe:
CrCl <30 mL/min: Not recommended (insufficient data for ER formulation). For IR, CrCl <15 mL/min: Not recommended.
Dialysis:
Not recommended (insufficient data for ER formulation). For IR, consider dose reduction and monitoring.
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 compensating for dopamine deficiency in Parkinson's disease.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
6 hours (ER formulation)
FoodEffect:
Food does not affect the extent of absorption but may decrease the rate of absorption, leading to a later Tmax.
Distribution:
Vd:
Approximately 400 L
ProteinBinding:
Less than 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-12 hours (increases with renal impairment)
Clearance:
Approximately 400 mL/min (renal clearance accounts for >90% of total clearance)
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
More than 90%
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration and ER formulation)
PeakEffect:
Reached after several weeks of titration to an effective dose.
DurationOfAction:
24 hours (ER formulation)
Confidence:
High
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 notice any of the following symptoms, contact your doctor 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
Increased 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
Some people have experienced sudden, uncontrollable sleepiness, even when feeling alert beforehand. This can occur up to 1 year after starting the medication. If you fall asleep during activities like driving, eating, or talking, do not engage in tasks that require alertness and contact your doctor immediately.
Additionally, some individuals have reported changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when 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 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, seek medical help immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you are concerned about any of the following side effects or if they persist, 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 potential side effects. If you have questions or concerns, 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:
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
Increased 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
Some people have experienced sudden, uncontrollable sleepiness, even when feeling alert beforehand. This can occur up to 1 year after starting the medication. If you fall asleep during activities like driving, eating, or talking, do not engage in tasks that require alertness and contact your doctor immediately.
Additionally, some individuals have reported changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when 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 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, seek medical help immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you are concerned about any of the following side effects or if they persist, 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 potential side effects. If you have questions or concerns, 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
- Severe dizziness or fainting spells
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., uncontrollable gambling, increased sexual urges, compulsive shopping, binge eating)
- New or worsening uncontrolled movements (dyskinesia)
- Confusion or unusual thoughts
- Swelling in the ankles or feet
- Muscle stiffness, fever, confusion, sweating, or rapid heart rate (signs of neuroleptic malignant syndrome-like reaction if stopped suddenly)
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 performing tasks that require your full attention, such as driving, until you understand how it affects you. 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. 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, sleep disturbances, 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, discuss the potential risks with your doctor.
If you notice what appears to be a tablet in your stool, consult 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 your full attention, such as driving, until you understand how it affects you. 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. 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, sleep disturbances, 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, discuss the potential risks with your doctor.
If you notice what appears to be a tablet in your stool, consult 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)
- Agitation
- Hypotension (low blood pressure)
- Hallucinations
- Confusion
What to Do:
There is no known antidote for pramipexole overdose. Treatment should be supportive and involve general supportive measures. Gastric lavage may be indicated if ingestion is recent. Monitor vital signs and mental status. Dialysis is not effective in removing pramipexole. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
Moderate Interactions
- Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May decrease renal clearance of pramipexole by inhibiting renal tubular secretion, leading to increased pramipexole levels.
- 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 necessary in renal impairment.
Timing: Prior to initiation of therapy.
Blood pressure (orthostatic)
Rationale: Pramipexole can cause orthostatic hypotension, especially during titration.
Timing: Prior to initiation and during titration.
Mental status/Psychiatric history
Rationale: Assess for pre-existing psychiatric conditions or risk factors for impulse control disorders or hallucinations.
Timing: Prior to initiation.
Ophthalmologic exam
Rationale: Although rare, retinal changes have been observed in animal studies with pramipexole. Baseline exam may be considered.
Timing: Prior to initiation (optional).
Routine Monitoring
Blood pressure (orthostatic)
Frequency: Regularly, especially during dose titration and if symptoms of orthostatic hypotension occur.
Target: Maintain within patient's normal limits, minimize symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.
Mental status/Behavioral changes (e.g., impulse control disorders, hallucinations, confusion)
Frequency: At each follow-up visit.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Development of new or worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, confusion, or psychosis.
Somnolence/Sudden sleep onset
Frequency: At each follow-up visit.
Target: Patient remains alert and able to perform daily activities safely.
Action Threshold: Excessive daytime sleepiness, falling asleep during activities of daily living, or sudden sleep onset.
Dyskinesia (if on concomitant levodopa)
Frequency: At each follow-up visit.
Target: Minimize severity and frequency of dyskinesia.
Action Threshold: Worsening or new onset of troublesome dyskinesia.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Nausea
- Constipation
- Swelling in legs/feet (peripheral edema)
- Hallucinations (seeing or hearing things that are not there)
- Confusion
- Unusual urges or behaviors (e.g., gambling, shopping, eating, sexual urges)
- Excessive daytime sleepiness
- Falling asleep suddenly without warning
- Uncontrolled movements (dyskinesia)
- Weight gain
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 embryofetal toxicity (reduced fetal body weight, delayed ossification) at doses higher than human therapeutic doses. Risk in humans is unknown.
Second Trimester:
Risk in humans is unknown.
Third Trimester:
Risk in humans is unknown.
Lactation
Pramipexole is excreted into rat milk and may inhibit prolactin secretion in humans. It is not known whether pramipexole is excreted in human milk. Due to the potential for serious adverse reactions in nursing 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:
L3 - Moderate risk. Potential for inhibition of lactation and adverse effects on the infant (e.g., somnolence, effects on CNS).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Renal clearance of pramipexole decreases with age, necessitating careful dose titration and monitoring, especially in those with impaired renal function.
Clinical Information
Clinical Pearls
- Mirapex ER is designed for once-daily dosing and should be swallowed whole. Crushing or chewing will alter its extended-release properties.
- Patients should be warned about the potential for sudden sleep onset and advised to avoid driving or operating heavy machinery if they experience somnolence.
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) can occur and may require dose reduction or discontinuation. Patients and caregivers should be educated to recognize these behaviors.
- Orthostatic hypotension is common, especially during initial titration. Advise patients to rise slowly.
- Withdrawal symptoms (e.g., akinesia, rigidity, anxiety, depression, sweating, pain) can occur if pramipexole is stopped abruptly. Taper dose gradually over at least one week.
- Dyskinesia may occur or worsen, particularly when co-administered with levodopa. Dose adjustment of either medication may be necessary.
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine, apomorphine)
- Levodopa/carbidopa
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone, tolcapone)
- Amantadine
- Anticholinergics (for tremor, e.g., trihexyphenidyl, benztropine)
- Adenosine A2A receptor antagonists (e.g., istradefylline)
Cost & Coverage
Average Cost:
$300 - $600 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 your 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 medication taken, the amount, and the time it occurred.