Mirapex ER 1.5mg 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 Agent
Pharmacologic Class
Dopamine Agonist
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. This extended-release form is taken once a day and slowly releases the medicine over time.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
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 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 you experience stomach upset, taking it with food may help. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
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 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. Do not crush, chew, or divide the tablet; swallow it whole.
- 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.
- Avoid alcohol and other sedating medications, as they can increase drowsiness.
- Stand up slowly from a sitting or lying position to reduce dizziness from 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.
- 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:
Initial 0.375 mg orally once daily, titrated 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 weekly to a target dose of 1.5 mg/day. Further increases can be made by 0.75 mg increments weekly up to a maximum of 4.5 mg/day.
Parkinson's Disease (Advanced, with Levodopa):
Initial 0.375 mg once daily, increase by 0.375 mg weekly to a target dose of 1.5 mg/day. Further increases can be made by 0.75 mg increments weekly up to a maximum of 4.5 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 30-50 mL/min: Initial 0.375 mg every other day. Max 2.25 mg/day.
Moderate:
CrCl 15-29 mL/min: Initial 0.375 mg twice weekly. Max 1.5 mg/day.
Severe:
CrCl <15 mL/min: Not recommended.
Dialysis:
Not recommended for patients on hemodialysis.
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 D3 receptors. It is thought to exert its antiparkinsonian effects by stimulating dopamine receptors in the striatum.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
6 hours (extended-release)
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 (longer in elderly and renally impaired patients)
Clearance:
Approximately 350 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
Approximately 90%
Pharmacodynamics
OnsetOfAction:
Gradual (titration required)
PeakEffect:
Achieved after several weeks of titration to an effective dose.
DurationOfAction:
24 hours (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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty passing urine
New or worsening mental, mood, or behavior changes
Important Warnings
Some people have experienced sudden, uncontrolled sleep episodes while engaging in 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 this, do not drive or perform tasks that require alertness, and contact your doctor immediately.
Changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways, can occur several months after starting the medication or after a dose increase. If you notice any changes in posture, contact your doctor.
Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening condition that can occur when the medication is stopped suddenly or 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 may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
* Flu-like symptoms
If any of these side effects bother you or persist, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty passing urine
New or worsening mental, mood, or behavior changes
Important Warnings
Some people have experienced sudden, uncontrolled sleep episodes while engaging in 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 this, do not drive or perform tasks that require alertness, and contact your doctor immediately.
Changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways, can occur several months after starting the medication or after a dose increase. If you notice any changes in posture, contact your doctor.
Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening condition that can occur when the medication is stopped suddenly or 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 may not experience any side effects or only minor ones, it is essential to be aware of the following potential side effects:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
* Flu-like symptoms
If any of these side effects bother you or persist, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
Seek Immediate Medical Attention If You Experience:
- Excessive daytime sleepiness or sudden sleep attacks
- Dizziness or fainting, especially when standing up
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, uncontrolled spending, binge eating)
- Uncontrolled, involuntary movements (dyskinesia)
- Nausea or vomiting that is severe or persistent
- Swelling in the ankles or feet
- Muscle cramps or pain
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 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 and the effectiveness of your treatment.
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 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 and the effectiveness of your treatment.
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, insomnia, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
While taking this medication, avoid consuming alcohol, as it may interact with the drug. Additionally, consult your doctor before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness or slow your reactions.
If you notice what appears to be a tablet in your stool, consult your doctor to determine the cause.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
As directed by your healthcare provider, regularly monitor your blood pressure to ensure it remains within a safe range.
Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the tapering schedule recommended by your doctor. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
While taking this medication, avoid consuming alcohol, as it may interact with the drug. Additionally, consult your doctor before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness or slow your reactions.
If you notice what appears to be a tablet in your stool, consult your doctor to determine the cause.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Somnolence
- Orthostatic hypotension
- Dyskinesia
- Hallucinations
- Agitation
- Confusion
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage may be indicated if ingestion is recent. General supportive measures, including intravenous fluids and monitoring of vital signs, are recommended. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of pramipexole.
- CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of pramipexole.
Moderate Interactions
- Cimetidine, Ranitidine, Diltiazem, Quinidine, Quinine, Procainamide, Verapamil: These drugs are eliminated by renal tubular secretion and may reduce the renal clearance of pramipexole, leading to increased plasma levels.
- Levodopa: May increase the incidence 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: Risk of orthostatic hypotension, especially during dose titration.
Timing: Prior to initiation and during dose titration.
Mental status/Psychiatric history
Rationale: Assess for pre-existing psychiatric conditions or risk factors for impulse control disorders and hallucinations.
Timing: Prior to initiation.
Routine Monitoring
Blood pressure (orthostatic)
Frequency: Regularly, especially during dose titration and with dose changes.
Target: Maintain within patient's normal limits, monitor for symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (dizziness, lightheadedness, syncope); consider dose reduction or discontinuation.
Somnolence/Sleep attacks
Frequency: Regularly, especially during dose titration.
Target: Absence of excessive daytime sleepiness or sudden sleep onset.
Action Threshold: Excessive daytime sleepiness or sudden sleep attacks; advise caution with driving/operating machinery, consider dose reduction or discontinuation.
Impulse control disorders (ICDs)
Frequency: Regularly, inquire about new or increased urges (e.g., gambling, hypersexuality, compulsive shopping, binge eating).
Target: Absence of new or worsening ICDs.
Action Threshold: Development of ICDs; consider dose reduction, discontinuation, or referral to specialist.
Hallucinations/Psychotic-like behavior
Frequency: Regularly, inquire about new or worsening symptoms.
Target: Absence of hallucinations or psychotic symptoms.
Action Threshold: Development of hallucinations or psychotic symptoms; consider dose reduction or discontinuation.
Dyskinesia (if co-administered with levodopa)
Frequency: Regularly.
Target: Minimize severity of dyskinesia.
Action Threshold: Worsening or new onset of troublesome dyskinesia; consider adjustment of pramipexole or levodopa dose.
Symptom Monitoring
- Dizziness or lightheadedness upon standing
- Excessive daytime sleepiness or sudden onset of sleep
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating)
- Nausea
- Constipation
- Swelling in legs or feet
- Muscle cramps
- Changes in vision
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 (skeletal malformations) at doses higher than human therapeutic doses. Risk in humans is unknown.
Second Trimester:
No specific data, but potential for adverse effects on fetal development cannot be excluded.
Third Trimester:
No specific data, but potential for adverse effects on fetal development cannot be excluded.
Lactation
Pramipexole is known to inhibit prolactin secretion in humans, which may inhibit lactation. It is also excreted into breast milk in rats. 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:
Risk of inhibition of lactation, potential for direct effects on infant (e.g., somnolence, effects on CNS).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is not recommended.
Geriatric Use
Elderly patients (âĨ65 years) have a reduced renal clearance of pramipexole, resulting in higher plasma concentrations and a longer elimination half-life. Dose adjustment is necessary based on renal function. Elderly patients may also be more susceptible to adverse effects such as hallucinations, somnolence, and orthostatic hypotension.
Clinical Information
Clinical Pearls
- Mirapex ER is designed for once-daily dosing and should not be crushed, chewed, or divided to maintain 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.
- Counsel 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 increased urges.
- Orthostatic hypotension is a common side effect, especially during initial titration. Advise patients to rise slowly.
- Dose adjustments are crucial in patients with renal impairment to prevent accumulation and increased side effects.
- Withdrawal symptoms (e.g., apathy, anxiety, depression, fatigue, sweating, pain) can occur if pramipexole is discontinued abruptly, especially after high doses or long-term treatment. Tapering is recommended.
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine transdermal system)
- Levodopa/carbidopa
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- Anticholinergics (for tremor, e.g., benztropine)
Cost & Coverage
Average Cost:
$200 - $600 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand, generic often Tier 1)
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.