Mirapex 0.125mg Tablets
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Antiparkinsonian agent; Agent for Restless Legs Syndrome
Pharmacologic Class
Dopamine agonist
Pregnancy Category
Category C
FDA Approved
Jul 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pramipexole is a medication that works by acting like a natural chemical in your brain called dopamine. It's used to help control the symptoms of Parkinson's disease, such as tremors, stiffness, and difficulty moving. It's also used to relieve the uncomfortable sensations and urge to move your legs that occur with Restless Legs Syndrome (RLS).
How to Use This Medicine
Taking Your Medication Correctly
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 closely. You can take this medication with or without food, but if it causes stomach upset, take it with food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. For restless leg syndrome, take your medication 2 to 3 hours before bedtime. If your symptoms worsen or start earlier in the day, inform your doctor.
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.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you miss taking your medication for several days in a row, contact your doctor before restarting 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 closely. You can take this medication with or without food, but if it causes stomach upset, take it with food.
It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. For restless leg syndrome, take your medication 2 to 3 hours before bedtime. If your symptoms worsen or start earlier in the day, inform your doctor.
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.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you miss taking your medication for several days in a row, contact your doctor before restarting your medication.
Lifestyle & Tips
- Take exactly as prescribed; do not stop suddenly without consulting your doctor.
- Avoid alcohol and other sedating medications, as they can increase drowsiness.
- Be aware of the risk of sudden sleep onset; avoid driving or operating machinery if you experience this.
- 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, shopping, sexual urges) to your doctor immediately.
- For RLS, take 2-3 hours before bedtime.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication and titration schedule.
Dose Range:
0.125 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease (initial):
0.125 mg orally three times daily. Titrate weekly by adding 0.125 mg/dose up to 1.5 mg three times daily (4.5 mg/day).
Restless Legs Syndrome (initial):
0.125 mg orally once daily 2-3 hours before bedtime. Titrate weekly by adding 0.125 mg/dose up to 0.5 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Parkinson's Disease (CrCl 35-59 mL/min): Initial 0.125 mg twice daily. Max 2.25 mg/day. RLS (CrCl 20-59 mL/min): Initial 0.125 mg every other day. Max 0.25 mg/day.
Moderate:
Parkinson's Disease (CrCl 15-34 mL/min): Initial 0.125 mg once daily. Max 1.5 mg/day. RLS (CrCl <20 mL/min): Not recommended.
Severe:
Parkinson's Disease (CrCl <15 mL/min): Not recommended.
Dialysis:
Parkinson's Disease: Not recommended. RLS: Not recommended.
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 receptors. It is believed to exert its antiparkinsonian effects by stimulating dopamine receptors in the striatum. For RLS, the mechanism is unknown but is thought to involve dopaminergic system activity.
Pharmacokinetics
Absorption:
Bioavailability:
90%
Tmax:
1-2 hours
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be delayed by approximately 1 hour.
Distribution:
Vd:
Approximately 400 L
ProteinBinding:
Less than 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8 hours (young adults); 12 hours (elderly)
Clearance:
Approximately 400 mL/min (renal clearance accounts for >90% of total clearance)
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Days to weeks (due to titration)
PeakEffect:
Weeks to months (after reaching stable dose)
DurationOfAction:
Approximately 24 hours (with once-daily dosing for RLS); effects persist with TID dosing for PD.
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty urinating
New or worsening mental, mood, or behavioral changes
Some people have experienced sudden, unexplained sleepiness, including falling asleep while driving, eating, or talking. If this happens, 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 uncontrolled 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 experience any changes in 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 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 Side Effects
Most people do not experience significant side effects, but some may occur. If you experience 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty urinating
New or worsening mental, mood, or behavioral changes
Some people have experienced sudden, unexplained sleepiness, including falling asleep while driving, eating, or talking. If this happens, 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 uncontrolled 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 experience any changes in 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 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 Side Effects
Most people do not experience significant side effects, but some may occur. If you experience 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:
- Sudden onset of sleep during daily activities (e.g., driving, talking)
- Severe dizziness or fainting, especially when standing up
- Hallucinations (seeing or hearing things that aren't there)
- Unusual urges or behaviors (e.g., uncontrollable gambling, increased sexual urges, compulsive shopping, binge eating)
- New or worsening uncontrolled movements (dyskinesia)
- Swelling in the legs or ankles
- Muscle pain or tenderness (rare, but could indicate rhabdomyolysis)
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. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease, as this may affect the medication's safety and efficacy.
* If you are currently taking another medication that contains the same active ingredient, to avoid potential interactions or duplications.
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 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, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease, as this may affect the medication's safety and efficacy.
* If you are currently taking another medication that contains the same active ingredient, to avoid potential interactions or duplications.
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 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.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
Follow your doctor's instructions for monitoring your blood pressure. Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, adhere to your doctor's guidance on how to do so safely. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.
Refrain from consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may impair your physical or mental responses, discuss the potential risks 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, consult your doctor to weigh the benefits and risks of this medication for both you and your baby.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
Follow your doctor's instructions for monitoring your blood pressure. Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, adhere to your doctor's guidance on how to do so safely. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.
Refrain from consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may impair your physical or mental responses, discuss the potential risks 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, consult your doctor to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Fainting
- Orthostatic hypotension
- Sweating
- Agitation
- Dyskinetic movements
- Hallucinations
- Confusion
- Sedation
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, intravenous fluids, and antiemetics. Dopamine antagonists may be considered if CNS stimulation is severe.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of pramipexole.
- Sedatives/CNS depressants (e.g., alcohol, benzodiazepines, opioids): May potentiate the sedative effects of pramipexole, increasing risk of somnolence and sudden sleep onset.
Moderate Interactions
- Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: May decrease the renal clearance of pramipexole by inhibiting active tubular secretion, leading to increased plasma levels.
- Levodopa: May increase the incidence of dyskinesia when co-administered with pramipexole in Parkinson's disease.
Confidence Interactions
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Pramipexole is primarily renally excreted; dose adjustments are necessary in renal impairment.
Timing: Prior to initiation
Blood pressure (orthostatic)
Rationale: Risk of orthostatic hypotension, especially during dose titration.
Timing: Prior to initiation
Mental status/Psychiatric history
Rationale: Risk of hallucinations, delusions, impulse control disorders, and psychosis.
Timing: Prior to initiation
Ophthalmologic exam
Rationale: Although rare, retinal changes have been observed in animal studies; baseline exam may be considered.
Timing: Prior to initiation (optional)
Routine Monitoring
Blood pressure (orthostatic)
Frequency: Regularly, especially during dose titration and with dose increases.
Target: Maintain stable BP, minimize symptomatic orthostasis.
Action Threshold: Symptomatic orthostatic hypotension (dizziness, lightheadedness, falls); consider dose reduction or discontinuation.
Mental status/Behavioral changes (e.g., impulse control disorders, hallucinations, somnolence)
Frequency: At each visit, inquire about new or worsening symptoms.
Target: Absence of new or worsening psychiatric/behavioral symptoms.
Action Threshold: Development of impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, delusions, or excessive daytime sleepiness/sudden sleep onset; consider dose reduction or discontinuation.
Motor symptoms (for PD)
Frequency: At each visit.
Target: Improvement in motor symptoms without excessive dyskinesia.
Action Threshold: Worsening of symptoms, development of severe dyskinesia; adjust dose or consider adjunctive therapy.
RLS symptoms (for RLS)
Frequency: At each visit.
Target: Reduction in RLS symptoms, absence of augmentation.
Action Threshold: Worsening of RLS symptoms, earlier onset of symptoms, or spread to other body parts (augmentation); consider dose adjustment or alternative therapy.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Falls
- Excessive daytime sleepiness
- Sudden sleep onset
- Hallucinations
- Delusions
- Confusion
- Unusual urges or behaviors (e.g., gambling, shopping, eating, sexual urges)
- Nausea
- Constipation
- Swelling in ankles/feet
- Muscle cramps
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on embryo-fetal development at doses higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women. Use 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 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 in rat milk and is known to inhibit prolactin secretion in humans, which could inhibit lactation. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L4 (Potentially hazardous). Risk of somnolence, feeding difficulties, and potential for inhibition of lactation.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
Clearance of pramipexole is reduced in elderly patients due to age-related decline in renal function. Dose adjustments are necessary based on renal function. Elderly patients may be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence.
Clinical Information
Clinical Pearls
- Pramipexole requires slow dose titration to minimize side effects, especially nausea, orthostatic hypotension, and somnolence.
- Patients should be warned about the potential for sudden sleep onset without warning, even during daily activities. Advise caution with driving or operating machinery.
- Monitor for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), which can occur in patients taking dopamine agonists. These behaviors may be reversible upon dose reduction or discontinuation.
- For Restless Legs Syndrome, augmentation (worsening of RLS symptoms, earlier onset, or spread to other body parts) can occur with long-term use of dopamine agonists. Consider alternative treatments if augmentation occurs.
- Discontinuation should be gradual to avoid withdrawal symptoms (e.g., akinesia, rigidity, anxiety, depression, sweating, pain), especially in Parkinson's patients.
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine, bromocriptine)
- Levodopa/carbidopa (for Parkinson's disease)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide) (for Parkinson's disease)
- COMT inhibitors (e.g., entacapone, opicapone) (for Parkinson's disease)
- Amantadine (for Parkinson's disease dyskinesia)
- Gabapentin enacarbil (for Restless Legs Syndrome)
- Opioids (for severe RLS, last resort)
- Benzodiazepines (for RLS, short-term use for sleep)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 tablets (0.125mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.