Pramipexole 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
Antiparkinsonian agent
Pharmacologic Class
Dopamine agonist, non-ergot
Pregnancy Category
Category C
FDA Approved
May 2010
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 brain chemical called dopamine, which helps control movement. The 'ER' means extended-release, so you take it once a day, and it slowly releases the medicine over 24 hours.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If it causes stomach upset, take it with food to help minimize discomfort. Continue taking your medication 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 moisture. Keep it in a dry place, away from bathrooms. Ensure all medications are stored in a safe location, out of 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 local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's been 12 hours or more since the missed dose, skip it and resume your regular schedule. Avoid taking two doses at the same time or taking extra doses.
If you've missed taking your medication for several days in a row, contact your doctor before restarting your medication regimen.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If it causes stomach upset, take it with food to help minimize discomfort. Continue taking your medication 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 moisture. Keep it in a dry place, away from bathrooms. Ensure all medications are stored in a safe location, out of 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 local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's been 12 hours or more since the missed dose, skip it and resume your regular schedule. Avoid taking two doses at the same time or taking extra doses.
If you've missed 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 it once daily with or without food. Taking it with food may help if you experience nausea.
- Avoid sudden changes in position (e.g., standing up quickly) to reduce dizziness or lightheadedness.
- Be aware of potential for sudden sleep onset; avoid driving or operating machinery if you experience excessive sleepiness.
- Report any new or worsening compulsive behaviors (e.g., gambling, shopping, eating, sexual urges) to your doctor.
- Avoid alcohol and other sedating medications unless approved by your doctor, as they can increase drowsiness.
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: 0.375 mg once daily. Titrate weekly by 0.375 mg increments. Maintenance: 1.5 mg to 4.5 mg once daily.
Dose Range:
0.375 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease (ER):
Initial: 0.375 mg once daily. Titrate weekly by 0.375 mg increments to a maximum of 4.5 mg once daily. Doses above 1.5 mg/day may provide additional benefit in some patients.
Restless Legs Syndrome (ER):
Not indicated for RLS in ER formulation. IR formulation is used for RLS.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: Initial 0.375 mg once daily. Max 2.25 mg once daily.
Moderate:
CrCl 30-49 mL/min: Initial 0.375 mg every other day. Max 2.25 mg every other day.
Severe:
CrCl <30 mL/min: Not recommended. Consider IR formulation with significant dose reduction.
Dialysis:
Not recommended. Pramipexole is dialyzable, but specific dosing for dialysis patients is not established for ER formulation.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Pramipexole is a non-ergot dopamine agonist with high affinity and selectivity for the D2 subfamily of dopamine receptors, particularly D2 and D3 receptor subtypes. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum, thereby mimicking the effects of dopamine and improving motor symptoms in Parkinson's disease.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
6 hours (ER formulation)
FoodEffect:
Food does not affect the extent of absorption but may decrease the rate of absorption, leading to a delay in Tmax by approximately 2 hours.
Distribution:
Vd:
Approximately 400 L
ProteinBinding:
Less than 20%
CnssPenetration:
Yes
Elimination:
HalfLife:
8-12 hours (ER formulation, increases with age and renal impairment)
Clearance:
Approximately 30 L/hour (primarily renal)
ExcretionRoute:
Renal (urine)
Unchanged:
More than 90%
Pharmacodynamics
OnsetOfAction:
Gradual (titration required)
PeakEffect:
Achieved after several weeks of titration to an effective dose.
DurationOfAction:
24 hours (ER formulation)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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
Some people have experienced sudden, uncontrollable sleepiness, including falling asleep while driving, eating, or talking. If this happens to you, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Additionally, some individuals 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 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 Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Vivid or unusual 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 or seek medical attention right away:
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
Some people have experienced sudden, uncontrollable sleepiness, including falling asleep while driving, eating, or talking. If this happens to you, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.
Additionally, some individuals 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 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 Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Headache
Constipation
Diarrhea
Upset stomach
Decreased appetite
Trouble sleeping
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Vivid or unusual 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
- Hallucinations (seeing or hearing things that aren't there)
- Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Severe dizziness or fainting, especially when standing up
- Uncontrolled, involuntary movements (dyskinesia)
- Swelling in the legs or ankles
- Nausea or vomiting that is severe or persistent
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the 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 duplication of therapy.
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. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the 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 duplication of therapy.
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. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down 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. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, 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.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.
When starting this medication, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down 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. Immediately contact your doctor if you experience any of the following symptoms when reducing the dose or stopping the medication: fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may cause drowsiness, 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.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Hyperkinesia (excessive movement)
- Hallucinations
- Agitation
- Hypotension
- Sedation
What to Do:
Call 911 or your local emergency number immediately. For advice, call a poison control center at 1-800-222-1222. Supportive measures, including gastric lavage, intravenous fluids, and antiemetics, may be considered. Dopamine antagonists may be used if CNS stimulation is present.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
- Cimetidine, Ranitidine, Diltiazem, Quinidine, Quinine, Triamterene, Verapamil: May decrease renal clearance of pramipexole, leading to increased plasma levels.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Pramipexole is primarily renally excreted; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation
Blood pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation
Psychiatric history (e.g., psychosis, impulse control disorders)
Rationale: Pramipexole can exacerbate or induce psychiatric symptoms and impulse control disorders.
Timing: Prior to initiation
Ophthalmologic exam
Rationale: Although less common with non-ergot agonists, baseline eye exam is prudent.
Timing: Prior to initiation
Routine Monitoring
Blood pressure (sitting and standing)
Frequency: Regularly, especially during dose titration and if symptoms of orthostatic hypotension occur.
Target: Maintain within patient's normal range, minimize orthostatic drop.
Action Threshold: Significant symptomatic orthostatic hypotension (e.g., >20 mmHg systolic or >10 mmHg diastolic drop with symptoms) may require dose reduction or discontinuation.
Psychiatric symptoms (hallucinations, delusions, confusion)
Frequency: Regularly, especially during dose titration.
Target: Absence of new or worsening symptoms.
Action Threshold: New onset or worsening of symptoms may require dose reduction or discontinuation.
Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
Frequency: Regularly, inquire directly with patient and caregiver.
Target: Absence of new or worsening compulsive behaviors.
Action Threshold: New onset or worsening of behaviors may require dose reduction or discontinuation.
Somnolence/Sudden sleep onset
Frequency: Regularly, inquire about daytime sleepiness or sudden sleep attacks.
Target: Maintain alertness during waking hours.
Action Threshold: Significant somnolence or sudden sleep attacks may require dose reduction or discontinuation, and patient counseling on driving/operating machinery.
Motor symptoms of Parkinson's disease
Frequency: Regularly, to assess therapeutic efficacy.
Target: Improvement in motor scores (e.g., UPDRS).
Action Threshold: Lack of efficacy may warrant dose increase (up to max) or addition of other therapies.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Hallucinations (visual, auditory, tactile)
- Delusions
- Confusion
- Dyskinesia (involuntary movements, especially if used with levodopa)
- Excessive daytime sleepiness
- Sudden sleep onset (sleep attacks)
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Nausea
- Constipation
- Peripheral edema
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.
Third Trimester:
Potential for developmental toxicity observed in animal studies.
Lactation
Pramipexole is excreted into rat milk, and it is likely to be excreted into human milk. It can inhibit prolactin secretion, potentially suppressing 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:
L3 (Moderate risk). Potential for central nervous system effects (e.g., somnolence, decreased feeding) and theoretical risk of long-term effects on dopamine system. May decrease milk supply.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in pediatric populations.
Geriatric Use
Renal clearance of pramipexole decreases with age. Dose adjustment is recommended for 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 taken once daily, offering convenience compared to the IR formulation.
- Titration is crucial to minimize side effects, especially nausea, orthostatic hypotension, and somnolence.
- Patients should be warned about the potential for sudden sleep attacks and impulse control disorders, and caregivers should also be informed.
- Renal function must be assessed before initiation and monitored periodically, as dose adjustments are critical in renal impairment.
- While less common with non-ergot agonists, peripheral edema can occur.
- If discontinuing, taper the dose gradually over several days to avoid withdrawal symptoms (e.g., akinesia, rigidity, anxiety, depression, sweating, pain).
Alternative Therapies
- Other dopamine agonists (e.g., ropinirole, rotigotine patch)
- Levodopa/carbidopa (first-line for motor symptoms in many patients)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- Istradefylline
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.