Pramipexole 0.25mg Tablets
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Dopamine Agonist
Pharmacologic Class
Non-ergoline Dopamine Agonist
Pregnancy Category
Category C
FDA Approved
Jul 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pramipexole is a medication used to treat Parkinson's disease and restless legs syndrome. It works by acting like a natural chemical in your brain called dopamine, which helps control movement.
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're feeling well.
For individuals with restless leg syndrome, take this 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing 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 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're feeling well.
For individuals with restless leg syndrome, take this 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing 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.
- Be aware of potential sudden sleep onset; avoid driving or operating machinery if you experience drowsiness.
- Rise slowly from a sitting or lying position to minimize dizziness from low blood pressure.
- Avoid alcohol and other sedating medications, as they 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.
- Do not crush, chew, or break extended-release tablets.
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:
For Parkinson's Disease: Initial 0.125 mg three times daily. For Restless Legs Syndrome: Initial 0.125 mg once daily 2-3 hours before bedtime.
Dose Range:
0.125 - 4.5 mg
Condition-Specific Dosing:
Parkinson's Disease:
Titrate weekly in 0.125 mg increments to 0.25 mg, then 0.5 mg, then 0.75 mg, then 1.0 mg, then 1.25 mg, then 1.5 mg three times daily. Max 4.5 mg/day.
Restless Legs Syndrome:
Titrate weekly in 0.125 mg increments to 0.25 mg, then 0.5 mg, then 0.75 mg once daily. Max 0.75 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 35-59 mL/min: Parkinson's: Initial 0.125 mg twice daily, max 2.25 mg/day. RLS: Initial 0.125 mg every other day, max 0.25 mg/day.
Moderate:
CrCl 15-34 mL/min: Parkinson's: Initial 0.125 mg once daily, max 1.5 mg/day. RLS: Initial 0.125 mg every other day, max 0.125 mg/day.
Severe:
CrCl <15 mL/min: Not recommended. If used, consider further dose reduction and careful monitoring.
Dialysis:
Not recommended due to insufficient data. Pramipexole is dialyzable.
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 D2 and D3 dopamine receptors, with higher affinity for D3 receptors. It is believed to exert its therapeutic effects by stimulating dopamine receptors in the striatum.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
1-3 hours
FoodEffect:
Food does not affect the extent of absorption but may delay the time to peak concentration (Tmax).
Distribution:
Vd:
Approximately 400 L
ProteinBinding:
<20%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8 hours (young adults), 12 hours (elderly)
Clearance:
Primarily renal clearance via glomerular filtration and active tubular secretion.
ExcretionRoute:
Urine
Unchanged:
Approximately 90%
Pharmacodynamics
OnsetOfAction:
Days to weeks (with titration)
PeakEffect:
Achieved after several weeks of dose titration to an effective maintenance dose.
DurationOfAction:
Approximately 6-8 hours for immediate-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
Increased 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
Important Warnings
Some people have experienced sudden, uncontrollable sleepiness, even during activities like driving, eating, or talking. This can occur up to 1 year after starting the medication. If you experience excessive sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.
Changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways, can occur several months after starting the medication or after a dose increase. If you notice any changes in posture, contact your doctor.
Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or abnormal heartbeat
+ Excessive sweating
Other Possible Side Effects
While many people do not experience side effects or only have mild ones, it is essential to be aware of the following potential side effects:
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
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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
Increased 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
Important Warnings
Some people have experienced sudden, uncontrollable sleepiness, even during activities like driving, eating, or talking. This can occur up to 1 year after starting the medication. If you experience excessive sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.
Changes in posture, such as neck bending forward, bending forward at the waist, or tilting sideways, can occur several months after starting the medication or after a dose increase. If you notice any changes in posture, contact your doctor.
Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening condition that can occur when medications like this one are stopped abruptly or the dose is lowered. If you experience any of the following symptoms, contact your doctor immediately:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or abnormal heartbeat
+ Excessive sweating
Other Possible Side Effects
While many people do not experience side effects or only have mild ones, it is essential to be aware of the following potential side effects:
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
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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:
- Severe dizziness or fainting spells
- Hallucinations (seeing or hearing things that are not there)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, compulsive shopping, binge eating)
- Falling asleep suddenly during daily activities
- New or worsening involuntary movements (dyskinesia)
- Swelling in the ankles or feet
- Unexplained fever, muscle stiffness, or confusion (signs of neuroleptic malignant syndrome-like reaction, 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure safe use and potential interactions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 symptoms you experienced.
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.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure safe use and potential interactions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires your full attention, 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 climbing stairs.
Monitor your blood pressure as instructed 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 withdrawal plan outlined 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, sleep disturbances, sweating, or pain.
Refrain from consuming alcohol while taking this medication. Prior to using marijuana, cannabis, or prescription or over-the-counter medications that may impair your physical or mental responses, consult 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, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.
Before operating a vehicle or engaging in any activity that requires your full attention, 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 climbing stairs.
Monitor your blood pressure as instructed 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 withdrawal plan outlined 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, sleep disturbances, sweating, or pain.
Refrain from consuming alcohol while taking this medication. Prior to using marijuana, cannabis, or prescription or over-the-counter medications that may impair your physical or mental responses, consult 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, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dyskinesia
- Hallucinations
- Hypotension
- Sedation
- Hyperkinesia
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Gastric lavage, intravenous fluids, and antiemetics may be considered. Monitor vital signs and cardiac rhythm. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines, metoclopramide): May reduce the efficacy of pramipexole.
- CNS depressants (e.g., alcohol, sedatives, hypnotics): May potentiate the sedative effects of pramipexole.
Moderate Interactions
- Drugs eliminated by renal tubular secretion (e.g., cimetidine, ranitidine, diltiazem, quinidine, quinine, verapamil): May decrease the renal clearance of pramipexole, leading to increased plasma levels.
Monitoring
Baseline Monitoring
Renal function (CrCl or eGFR)
Rationale: Pramipexole is primarily renally excreted; dose adjustment is required in renal impairment.
Timing: Prior to initiation of therapy.
Blood pressure (sitting and standing)
Rationale: To assess for orthostatic hypotension risk.
Timing: Prior to initiation of therapy.
Psychiatric history (e.g., psychosis, impulse control disorders)
Rationale: To identify predisposition to psychiatric adverse effects.
Timing: Prior to initiation of therapy.
Ophthalmologic examination
Rationale: Although not definitively linked, some dopamine agonists have been associated with retinal changes in animals.
Timing: Prior to initiation of therapy.
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 symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant asymptomatic drop (e.g., >20 mmHg systolic, >10 mmHg diastolic).
Mental status and behavior (e.g., hallucinations, delusions, impulse control disorders, somnolence)
Frequency: Regularly, at each visit, and inquire about new or worsening symptoms.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Development of hallucinations, delusions, confusion, or new/worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), or excessive daytime sleepiness/sleep attacks.
Motor symptoms (e.g., dyskinesia, worsening Parkinson's symptoms, RLS augmentation)
Frequency: Regularly, at each visit.
Target: Optimal symptom control with minimal adverse effects.
Action Threshold: Development of troublesome dyskinesia, inadequate symptom control, or augmentation/rebound in RLS.
Renal function
Frequency: Periodically, especially in elderly patients or those with risk factors for renal impairment.
Target: Not applicable.
Action Threshold: Significant decline in renal function requiring dose adjustment.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Hallucinations (visual, auditory, tactile)
- Delusions or paranoia
- Excessive daytime sleepiness or sudden sleep onset ('sleep attacks')
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Dyskinesia (involuntary movements)
- Nausea, constipation
- Peripheral edema
- Worsening of Parkinson's symptoms or RLS (augmentation/rebound)
Special Patient Groups
Pregnancy
Pramipexole is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies showed developmental toxicity (e.g., skeletal malformations, reduced fetal weight) at doses higher than human therapeutic doses.
Second Trimester:
Not specifically studied in humans; animal data suggest potential for adverse effects.
Third Trimester:
Not specifically studied in humans; animal data suggest potential for adverse effects.
Lactation
Pramipexole is excreted into rat milk and may inhibit lactation in humans due to its dopamine agonist activity. It is not known if pramipexole is excreted in human milk. 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 inhibition of lactation and unknown effects on the breastfed infant. Monitor infant for drowsiness, poor feeding, or unusual movements.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
Renal clearance of pramipexole decreases with age. Dose adjustment is required 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
- Titrate dose slowly to minimize adverse effects, especially orthostatic hypotension and somnolence.
- Warn patients about the potential for sudden sleep onset and advise against driving or operating machinery if this occurs.
- Educate patients and caregivers about the risk of impulse control disorders and encourage prompt reporting of any new or unusual behaviors.
- Monitor for augmentation or rebound in Restless Legs Syndrome, which may necessitate dose adjustment or alternative therapy.
- Discontinuation should be gradual to avoid withdrawal symptoms (e.g., akinesia, rigidity, anxiety, depression, sweating, pain).
Alternative Therapies
- For Parkinson's Disease: Ropinirole (another non-ergoline dopamine agonist), rotigotine (transdermal patch dopamine agonist), levodopa/carbidopa, MAO-B inhibitors (e.g., selegiline, rasagiline), COMT inhibitors (e.g., entacapone), amantadine.
- For Restless Legs Syndrome: Ropinirole, rotigotine, gabapentin enacarbil, pregabalin, iron supplementation (if iron deficiency is present).
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150+ per 30 tablets (0.25mg)
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or Tier 2 for generic formulations, Tier 3 or higher for brand-name.
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 details. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.