Pramipexole ER 0.75mg Tablets
It is used to treat Parkinson's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiparkinsonian agent
Pharmacologic Class
Non-ergot dopamine receptor agonist
Pregnancy Category
Category C
FDA Approved
May 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pramipexole ER is a medication used to treat Parkinson's disease. It works by acting like a natural substance in your brain called dopamine, which helps control movement. The 'ER' means extended-release, so you take it once a day.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If it causes stomach upset, take it with food to help minimize this side effect. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
When taking your medication, swallow the tablet whole. Do not chew, break, or crush it, as this can affect how the medication works.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom, and keep it out of reach of children and pets. If you have unused or expired medication, 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. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program 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 return to 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 it causes stomach upset, take it with food to help minimize this side effect. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
When taking your medication, swallow the tablet whole. Do not chew, break, or crush it, as this can affect how the medication works.
Storing and Disposing of Your Medication
To keep your medication effective and safe, store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom, and keep it out of reach of children and pets. If you have unused or expired medication, 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. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program 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 return to 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 the tablet whole; do not chew, crush, or divide it.
- Take at approximately the same time each day, with or without food.
- Avoid sudden changes in position (e.g., standing up quickly) to reduce dizziness from low blood pressure.
- Be aware of potential for sudden sleep attacks; avoid driving or operating machinery if you experience excessive sleepiness.
- Limit or avoid alcohol, as it can increase drowsiness.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
- Pramipexole 0.5mg Tablets
- Pramipexole 0.25mg Tablets
- Pramipexole 1mg Tablets
- Pramipexole 1.5mg Tablets
- Pramipexole 0.125mg Tablets
- Pramipexole 0.75mg Tablets
- Pramipexole ER 4.5mg Tablets
- Pramipexole ER 1.5mg Tablets
- Pramipexole ER 3mg Tablets
- Pramipexole ER 0.375mg Tablets
- Pramipexole ER 0.75mg Tablets
- Pramipexole ER 0.75mg Tablets
- Pramipexole ER 0.375mg Tablets
- Pramipexole ER 1.5mg Tablets
- Pramipexole ER 3.75mg Tablets
- Pramipexole ER 4.5mg Tablets
- Pramipexole ER 3mg Tablets
- Pramipexole ER 2.25mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose for Parkinson's disease is 0.375 mg once daily. Dose should be titrated gradually, not more frequently than every 5-7 days, to a target therapeutic dose.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial: 0.375 mg once daily. Titrate gradually by 0.375 mg increments at 5-7 day intervals to a maximum of 4.5 mg once daily. Typical effective dose range is 1.5 mg to 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: No dose adjustment required.
Moderate:
CrCl 30-49 mL/min: Initial dose 0.25 mg once daily. Maximum dose 2.25 mg once daily.
Severe:
CrCl 15-29 mL/min: Initial dose 0.125 mg once daily. Maximum dose 1.5 mg once daily.
Dialysis:
CrCl <15 mL/min or patients on hemodialysis: Not recommended due to insufficient data and potential for accumulation.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required.
Pharmacology
Mechanism of Action
Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for D2 and D3 dopamine receptors, with higher affinity for D3 receptors. It is believed to exert its antiparkinsonian effects by stimulating dopamine receptors in the striatum.
Pharmacokinetics
Absorption:
Bioavailability:
90%
Tmax:
6 hours (range 2-12 hours) for ER formulation
FoodEffect:
Food does not affect the extent of absorption, but Tmax may be prolonged by approximately 2 hours.
Distribution:
Vd:
400 L
ProteinBinding:
15%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-12 hours (increases with age and renal impairment)
Clearance:
Approximately 300 mL/min (primarily renal)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Gradual, requires titration over several weeks to achieve therapeutic effect.
PeakEffect:
Achieved after several weeks of titration to a stable dose.
DurationOfAction:
Approximately 24 hours for the extended-release formulation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty urinating
New or worsening mental, mood, or behavioral changes
Some people have experienced sudden, unexplained sleepiness, even during activities like driving, eating, or talking. If this happens to you, do not drive or engage in tasks 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. 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 abruptly 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Strange or vivid dreams
Muscle spasms
Weight loss
Stuffy nose
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Fever
Confusion
Muscle stiffness
Frequent urination
Severe dizziness or fainting
Excessive sweating
Shortness of breath, significant weight gain, or swelling in the arms or legs
Changes in vision
New or worsening trouble controlling body movements
Difficulty moving around
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Muscle pain or weakness, dark urine, or difficulty urinating
New or worsening mental, mood, or behavioral changes
Some people have experienced sudden, unexplained sleepiness, even during activities like driving, eating, or talking. If this happens to you, do not drive or engage in tasks 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. 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 abruptly 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, 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
- Severe dizziness or fainting, especially when standing up
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, compulsive shopping, binge eating)
- Uncontrolled, involuntary movements (dyskinesia)
- Swelling in the legs or ankles
- Confusion or agitation
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 how your body processes the medication.
* If you are currently taking another medication that contains the same active ingredient, to avoid potential interactions or duplicate dosing.
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 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, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
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, to avoid potential interactions or duplicate dosing.
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 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.
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, follow your doctor's guidance on how to taper off the dose. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor. If you notice what appears to be a tablet in your stool, discuss this with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to make an informed decision.
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.
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, follow your doctor's guidance on how to taper off the dose. Be aware of potential withdrawal symptoms, which may include fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor. If you notice what appears to be a tablet in your stool, discuss this with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to make an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Lightheadedness
- Orthostatic hypotension
- Sweating
- Agitation
- Dyskinetic movements
- Hallucinations
- Sedation
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Supportive care and gastric lavage may be considered. There is no known antidote.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., phenothiazines, butyrophenones, thioxanthenes, metoclopramide): May reduce the effectiveness of pramipexole.
- Sedatives, hypnotics, alcohol: May potentiate the sedative effects of pramipexole.
Moderate Interactions
- Cimetidine, Ranitidine, Diltiazem, Verapamil, Quinidine, Quinine: These drugs are renally eliminated via the organic cation transport system and may reduce the renal clearance of pramipexole, leading to increased plasma levels.
- Other drugs that cause orthostatic hypotension: May increase the risk of orthostatic hypotension when co-administered with pramipexole.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Pramipexole is primarily renally eliminated; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation of therapy.
Blood pressure (supine and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation of therapy.
Mental status/Psychiatric history
Rationale: To assess for baseline risk of hallucinations, psychosis, or impulse control disorders.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (Parkinson's symptoms)
Frequency: Regularly during titration and periodically thereafter.
Target: Improvement in motor symptoms (e.g., tremor, rigidity, bradykinesia).
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Orthostatic blood pressure
Frequency: Regularly during titration and periodically thereafter, especially if symptoms of dizziness or lightheadedness occur.
Target: Stable blood pressure without significant orthostatic drop.
Action Threshold: Sustained orthostatic hypotension (e.g., drop of >20 mmHg systolic or >10 mmHg diastolic) may require dose reduction or discontinuation.
Somnolence/Sudden sleep onset
Frequency: Regularly, inquire about daytime sleepiness.
Target: Alertness during waking hours.
Action Threshold: Excessive daytime sleepiness or sudden sleep attacks warrant dose reduction or discontinuation, and patient counseling on driving/operating machinery.
Hallucinations/Psychotic-like behavior
Frequency: Regularly, inquire about new or worsening psychiatric symptoms.
Target: Absence of hallucinations or psychotic symptoms.
Action Threshold: Presence of these symptoms warrants dose reduction or discontinuation.
Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
Frequency: Regularly, inquire about new or worsening compulsive behaviors.
Target: Absence of new or worsening compulsive behaviors.
Action Threshold: Development of these behaviors warrants dose reduction, discontinuation, or referral to a specialist.
Dyskinesia
Frequency: Regularly, especially if co-administered with levodopa.
Target: Absence or minimal dyskinesia.
Action Threshold: Significant dyskinesia may require dose adjustment of pramipexole or levodopa.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting)
- Excessive daytime sleepiness or sudden sleep onset
- Hallucinations (visual, auditory)
- Delusions or psychotic-like behavior
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Dyskinesia (involuntary movements)
- Nausea
- Constipation
- Peripheral edema
- Weight changes
Special Patient Groups
Pregnancy
Pramipexole is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Third Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses. May inhibit lactation.
Lactation
Pramipexole is excreted in rat milk and is known to inhibit prolactin secretion in humans, which can inhibit lactation. 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:
Potential for serious adverse effects in the infant due to drug excretion in milk and potential for inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is not recommended.
Geriatric Use
Renal clearance of pramipexole decreases with age. Dose adjustment is necessary in elderly patients with impaired renal function. Elderly patients may be at increased risk for hallucinations and orthostatic hypotension.
Clinical Information
Clinical Pearls
- Pramipexole ER should be swallowed whole and not chewed, crushed, or divided, as this can alter its extended-release properties.
- Patients should be warned about the potential for sudden sleep attacks without prior warning, even during daily activities. This risk is higher with higher doses and in patients with pre-existing sleep disorders.
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) have been reported in patients treated with dopamine agonists, including pramipexole. Patients and caregivers should be regularly monitored for these behaviors.
- Orthostatic hypotension is a common side effect, especially during dose titration. Advise patients to rise slowly from a sitting or lying position.
- Hallucinations are more common in elderly patients and those with advanced Parkinson's disease. Dose reduction or discontinuation may be necessary.
- Withdrawal symptoms (e.g., akinesia, insomnia, depression, sweating) can occur if pramipexole is discontinued abruptly. Tapering the dose is recommended.
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)
- Amantadine
- Anticholinergics (for tremor)
Cost & Coverage
Average Cost:
$100 - $500+ per 30 tablets (highly variable by strength and pharmacy)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand, generic usually Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.