Mirapex ER 0.375mg 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
Oct 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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions exactly. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
It's essential to take your medication correctly: swallow the tablet whole and do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom, and out of reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 12 hours or more since the missed dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication to ensure it is safe to do so.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions exactly. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
It's essential to take your medication correctly: swallow the tablet whole and do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom, and out of reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 12 hours or more since the missed dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication to ensure it is safe to do so.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or divide it.
- Can be taken with or without food.
- Be aware of potential sudden sleep attacks; avoid driving or operating heavy machinery if you experience excessive sleepiness.
- Rise slowly from a sitting or lying position to minimize dizziness from low blood pressure (orthostatic hypotension).
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor.
- 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: 0.375 mg orally once daily. Titrate no more frequently than every 5-7 days. Maintenance: 1.5 mg to 4.5 mg orally once daily.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial: 0.375 mg orally once daily. Titrate weekly in 0.375 mg increments to 0.75 mg, then 1.5 mg, then 2.25 mg, then 3 mg, then 3.75 mg, then 4.5 mg. 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: No initial dose adjustment needed. Max dose 4.5 mg/day.
Moderate:
CrCl 30-49 mL/min: Initial 0.375 mg orally every other day. Titrate slowly. Max dose 2.25 mg/day.
Severe:
CrCl 15-29 mL/min: Initial 0.125 mg orally every other day. Titrate slowly. Max dose 1.5 mg/day.
Dialysis:
CrCl < 15 mL/min or on hemodialysis: Initial 0.125 mg orally twice weekly. Max dose 1.5 mg/day. Pramipexole is not significantly removed by 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 dopamine 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 (extended-release)
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be prolonged by approximately 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:
Renal (primarily unchanged drug)
Unchanged:
Approximately 90%
Pharmacodynamics
OnsetOfAction:
Gradual (due to titration)
PeakEffect:
Achieved after several weeks of titration to an effective dose.
DurationOfAction:
24 hours (extended-release formulation)
Confidence:
High
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 behavioral changes
Important Safety Information
Some people have experienced sudden, uncontrollable sleepiness while taking this medication, even if they felt 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 drive or engage in tasks that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Additionally, some people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when sitting, standing, or walking. These changes can occur several months after starting the medication or after a dose increase. Contact your doctor if you notice any changes in your posture.
Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you 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 behavioral changes
Important Safety Information
Some people have experienced sudden, uncontrollable sleepiness while taking this medication, even if they felt 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 drive or engage in tasks that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Additionally, some people have developed uncontrollable changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways when sitting, standing, or walking. These changes can occur several months after starting the medication or after a dose increase. Contact your doctor if you notice any changes in your posture.
Neuroleptic Malignant Syndrome (NMS)
NMS is a rare but potentially life-threatening condition that can occur when medications like this one are stopped suddenly or when the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Changes in thinking
Fast or abnormal heartbeat
Excessive sweating
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden onset of sleep during daily activities
- Severe dizziness or fainting, especially when standing up
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., uncontrollable gambling, increased sexual urges, compulsive shopping, binge eating)
- Uncontrolled, involuntary movements (dyskinesia)
- Swelling in the ankles or feet
- Muscle stiffness, fever, confusion (signs of neuroleptic malignant syndrome-like symptoms, rare but serious)
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 exercise caution when climbing stairs.
Regularly 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 to discuss potential interactions.
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 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.
Regularly 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 to discuss potential interactions.
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
- Dyskinesia
- Hallucinations
- Agitation
- Hypotension
- Sedation
What to Do:
There is no known antidote. Treatment is symptomatic and supportive. Gastric lavage may be indicated. General supportive measures should be employed, along with intravenous fluids, and the administration of antiemetics, if appropriate. Call 911 or Poison Control (1-800-222-1222).
Drug Interactions
Major Interactions
Moderate Interactions
- Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May reduce the renal clearance of pramipexole, leading to increased plasma concentrations.
- 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 eliminated; dose adjustment is required 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: Risk of hallucinations, delusions, impulse control disorders, and psychosis.
Timing: Prior to initiation.
Routine Monitoring
Blood pressure (orthostatic)
Frequency: Regularly, especially during dose titration and with dose increases.
Target: Maintain stable blood pressure, minimize orthostatic drops.
Action Threshold: Symptomatic orthostatic hypotension or significant drop (>20 mmHg systolic, >10 mmHg diastolic) requires dose adjustment or discontinuation.
Symptoms of Parkinson's Disease
Frequency: Regularly at follow-up visits.
Target: Improvement in motor symptoms (e.g., tremor, rigidity, bradykinesia).
Action Threshold: Lack of efficacy may warrant dose increase or alternative therapy.
Somnolence/Sleep attacks
Frequency: Regularly at follow-up visits.
Target: Absence of excessive daytime sleepiness or sudden sleep onset.
Action Threshold: Significant somnolence or sleep attacks require dose reduction or discontinuation, and patient counseling regarding driving/operating machinery.
Impulse control disorders (ICDs)
Frequency: Regularly at follow-up visits (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating).
Target: Absence of new or worsening ICDs.
Action Threshold: Development of ICDs requires dose reduction, discontinuation, or referral for behavioral management.
Hallucinations/Psychotic behavior
Frequency: Regularly at follow-up visits.
Target: Absence of hallucinations or psychotic symptoms.
Action Threshold: Development of these symptoms requires dose reduction or discontinuation.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Excessive daytime sleepiness or sudden sleep attacks
- Hallucinations (visual, auditory)
- Delusions or paranoid ideation
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Dyskinesia (involuntary movements)
- Nausea, constipation
- Peripheral edema
Special Patient Groups
Pregnancy
Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects at doses higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at high doses.
Second Trimester:
Potential for developmental toxicity observed in animal studies at high doses.
Third Trimester:
Potential for developmental toxicity observed in animal studies at high doses; theoretical risk of inhibiting lactation.
Lactation
Pramipexole is excreted into rat milk and may inhibit lactation. It is not known whether pramipexole is excreted in human milk. Because of 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 dopamine-related effects (e.g., somnolence, feeding difficulties) and potential inhibition of lactation. L3 (Moderate risk).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
Renal clearance of pramipexole decreases with age. Dose adjustments are necessary in elderly patients with impaired renal function. Elderly patients may be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence.
Clinical Information
Clinical Pearls
- Pramipexole ER is designed for once-daily dosing and should not be crushed, chewed, or divided, as this will disrupt the extended-release mechanism.
- Patients should be warned about the potential for sudden onset of sleep during daily activities, even without prior warning signs of drowsiness. This risk is higher with higher doses and in patients with pre-existing sleep disorders.
- Monitor for impulse control disorders (ICDs) such as pathological gambling, hypersexuality, compulsive shopping, and binge eating. These can occur in patients treated with dopamine agonists and may require dose reduction or discontinuation.
- Orthostatic hypotension is a common side effect, especially during initial titration. Advise patients to rise slowly and monitor blood pressure.
- Hallucinations are more common in elderly patients and those with advanced Parkinson's disease. Dose reduction or discontinuation may be necessary if severe.
- Withdrawal symptoms (e.g., akinesia, insomnia, depression, sweating) can occur if pramipexole is discontinued abruptly, especially after high doses. Taper gradually over several days to a week.
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine, apomorphine)
- Levodopa/Carbidopa (e.g., Sinemet, Rytary, Duopa)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- Anticholinergics (e.g., trihexyphenidyl, benztropine - for tremor)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$600+ per 30 tablets (0.375mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about 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.