Neupro 3mg/24hr TD Patch
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
Apr 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Neupro is a patch that you apply to your skin once a day. It contains a medicine called rotigotine, which works like a natural chemical in your brain called dopamine. It helps to improve symptoms of Parkinson's disease, like tremors and stiffness, and also helps with the uncomfortable leg sensations of Restless Legs Syndrome.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow these guidelines carefully to ensure safe and effective use.
Do not cut or divide the patches, and do not use any that are damaged.
Before and after handling the patches, wash your hands thoroughly.
Apply the patch to clean, dry, and healthy skin on the following areas: belly, hip, side, shoulder, upper leg, or upper arm. Choose a different location each time you apply a new patch, and avoid using the same site for 14 days.
Apply the patch at the same time every day to maintain a consistent routine.
Avoid placing the patch on skin that is irritated, damaged, or has folds, as well as areas that will be rubbed by tight clothing.
Do not apply the patch to skin where you have recently used creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
If you need to apply the patch to a hairy area, shave the site 3 days before application to ensure a secure fit.
When applying the patch, press it firmly in place for 30 seconds to ensure it adheres properly.
Be careful not to dislodge the patch while bathing or showering. If the patch falls off, replace it with a new one. If the patch loosens, use tape only on the edges to secure it.
After removing the patch, wash the site with soap and water.
Continuing Your Medication
Continue using this medication as directed by your doctor or healthcare provider, even if you feel well. It's essential to maintain your treatment schedule to achieve the best results.
Storage and Disposal
To store this medication properly:
Keep it at room temperature in a dry place, away from the bathroom.
Store the patches in their pouch until you're ready to use them.
* After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Missing a Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one. If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not apply more than one patch at a time.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow these guidelines carefully to ensure safe and effective use.
Do not cut or divide the patches, and do not use any that are damaged.
Before and after handling the patches, wash your hands thoroughly.
Apply the patch to clean, dry, and healthy skin on the following areas: belly, hip, side, shoulder, upper leg, or upper arm. Choose a different location each time you apply a new patch, and avoid using the same site for 14 days.
Apply the patch at the same time every day to maintain a consistent routine.
Avoid placing the patch on skin that is irritated, damaged, or has folds, as well as areas that will be rubbed by tight clothing.
Do not apply the patch to skin where you have recently used creams, oils, lotions, powder, or other skin products, as this may affect the patch's adhesion.
If you need to apply the patch to a hairy area, shave the site 3 days before application to ensure a secure fit.
When applying the patch, press it firmly in place for 30 seconds to ensure it adheres properly.
Be careful not to dislodge the patch while bathing or showering. If the patch falls off, replace it with a new one. If the patch loosens, use tape only on the edges to secure it.
After removing the patch, wash the site with soap and water.
Continuing Your Medication
Continue using this medication as directed by your doctor or healthcare provider, even if you feel well. It's essential to maintain your treatment schedule to achieve the best results.
Storage and Disposal
To store this medication properly:
Keep it at room temperature in a dry place, away from the bathroom.
Store the patches in their pouch until you're ready to use them.
* After removing a used patch, fold the sticky sides together and dispose of it in a secure location where children and pets cannot access it.
Missing a Dose
If you miss a dose, apply a new patch as soon as you remember, after removing the old one. If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not apply more than one patch at a time.
Lifestyle & Tips
- Apply the patch to a clean, dry, hairless area of skin on your stomach, thigh, hip, flank, shoulder, or upper arm. Avoid areas that will be rubbed by tight clothing.
- Rotate application sites daily to prevent skin irritation. Do not apply to the same site for at least 14 days.
- Remove the old patch before applying a new one.
- Avoid applying external heat (e.g., heating pads, electric blankets, hot baths, saunas, direct sunlight) to the patch site, as this can increase drug absorption and side effects.
- Be cautious when standing up quickly, as this medication can cause dizziness or lightheadedness (orthostatic hypotension).
- Avoid or limit alcohol consumption, as it can increase drowsiness.
- Be aware of potential sudden sleep attacks and avoid driving or operating machinery if you experience excessive sleepiness.
- Discuss any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping, binge eating) with your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initiate with 2 mg/24hr patch once daily. Increase by 2 mg/24hr increments weekly. For Restless Legs Syndrome: Initiate with 1 mg/24hr patch once daily. Increase by 1 mg/24hr increments weekly.
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial 2 mg/24hr, titrate weekly by 2 mg/24hr increments to effective dose, max 8 mg/24hr.
Restless Legs Syndrome:
Initial 1 mg/24hr, titrate weekly by 1 mg/24hr increments to effective dose, max 3 mg/24hr.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
For Parkinson's Disease (CrCl <30 mL/min or ESRD): Max 4 mg/24hr. For Restless Legs Syndrome (CrCl <30 mL/min or ESRD): Max 2 mg/24hr.
Dialysis:
Consider dose reduction for ESRD patients as per severe impairment guidelines. Rotigotine is not dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
For Parkinson's Disease (Child-Pugh C): Max 4 mg/24hr. For Restless Legs Syndrome (Child-Pugh C): Max 2 mg/24hr.
Confidence:
High
Pharmacology
Mechanism of Action
Rotigotine is a non-ergoline dopamine agonist that stimulates D2, D3, and D1 dopamine receptors. The precise mechanism of action of rotigotine in Parkinson's disease and Restless Legs Syndrome is unknown, but it is believed to be related to its ability to stimulate dopamine receptors in the brain.
Pharmacokinetics
Absorption:
Bioavailability:
37%
Tmax:
15-30 hours (at steady state)
FoodEffect:
Not applicable (transdermal patch)
Distribution:
Vd:
84 L/kg
ProteinBinding:
Approximately 92%
CnssPenetration:
Yes
Elimination:
HalfLife:
5-7 hours (terminal half-life)
Clearance:
Not readily quantifiable for transdermal, but systemic clearance is high.
ExcretionRoute:
Urine (71%), Feces (23%)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Gradual (due to transdermal delivery and titration)
PeakEffect:
Steady state reached within 1-2 days of continuous patch application.
DurationOfAction:
24 hours (continuous release from patch)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Chest pain or pressure
Fast or abnormal heartbeat
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Confusion
Fever
Muscle pain
Muscle stiffness
Trouble controlling body movements (new or worsening)
Changes in eyesight
Changes in sex interest
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Sudden Sleepiness: A Rare but Serious Side Effect
In rare cases, this medication can cause sudden sleepiness, even during activities like driving, eating, or talking. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor right away if you experience sudden sleepiness or excessive sleepiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Constipation
Diarrhea
Nausea or vomiting
Upset stomach
Decreased appetite
Dizziness
Sleepiness
Fatigue
Weakness
Vivid or unusual dreams
Headache
Excessive sweating
Trouble sleeping
Joint pain
Irritation at the site of administration
Dry mouth
Nose or throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Chest pain or pressure
Fast or abnormal heartbeat
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Confusion
Fever
Muscle pain
Muscle stiffness
Trouble controlling body movements (new or worsening)
Changes in eyesight
Changes in sex interest
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Sudden Sleepiness: A Rare but Serious Side Effect
In rare cases, this medication can cause sudden sleepiness, even during activities like driving, eating, or talking. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor right away if you experience sudden sleepiness or excessive sleepiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Constipation
Diarrhea
Nausea or vomiting
Upset stomach
Decreased appetite
Dizziness
Sleepiness
Fatigue
Weakness
Vivid or unusual dreams
Headache
Excessive sweating
Trouble sleeping
Joint pain
Irritation at the site of administration
Dry mouth
Nose or throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Severe dizziness or fainting, especially when standing up
- Hallucinations (seeing or hearing things that are not there)
- Confusion or unusual thoughts
- New or worsening compulsive behaviors (e.g., uncontrollable urges to gamble, shop, eat, or engage in sexual activity)
- Excessive daytime sleepiness or sudden sleep attacks
- Uncontrolled, involuntary movements (dyskinesia)
- Severe skin irritation, redness, swelling, or blistering at the patch site
- Swelling in the ankles or feet
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Monitoring and Maintenance
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Allergies and Sensitivities
If you have a sulfite allergy, consult your doctor, as some products may contain sulfites. Additionally, be aware that the patch may contain metal, so it is crucial to remove it before undergoing an MRI or cardioversion.
Discontinuation and Withdrawal
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to discontinue use, follow your doctor's guidance on how to do so safely. Be aware of potential withdrawal signs, including fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain, and contact your doctor immediately if you experience any of these symptoms.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor.
Heat Precautions
Avoid exposure to heat sources, such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Refrain from taking long, hot baths or sunbathing, as this may cause your body temperature to rise and lead to excessive medication absorption.
Skin Irritation and Sun Exposure
If you experience skin irritation or a rash from the patch, avoid sun exposure on the affected area until the skin has healed, as sunlight may cause the irritated skin to change color.
Neuroleptic Malignant Syndrome (NMS)
Be aware of the risk of NMS, a potentially life-threatening condition that may occur when medications like this one are stopped abruptly or the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered thinking, rapid or abnormal heartbeat, or excessive sweating.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication to both you and your baby.
Restless Leg Syndrome
If you are taking this medication for restless leg syndrome, notify your doctor if your symptoms worsen or occur earlier in the day.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
Monitoring and Maintenance
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Allergies and Sensitivities
If you have a sulfite allergy, consult your doctor, as some products may contain sulfites. Additionally, be aware that the patch may contain metal, so it is crucial to remove it before undergoing an MRI or cardioversion.
Discontinuation and Withdrawal
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to discontinue use, follow your doctor's guidance on how to do so safely. Be aware of potential withdrawal signs, including fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain, and contact your doctor immediately if you experience any of these symptoms.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor.
Heat Precautions
Avoid exposure to heat sources, such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Refrain from taking long, hot baths or sunbathing, as this may cause your body temperature to rise and lead to excessive medication absorption.
Skin Irritation and Sun Exposure
If you experience skin irritation or a rash from the patch, avoid sun exposure on the affected area until the skin has healed, as sunlight may cause the irritated skin to change color.
Neuroleptic Malignant Syndrome (NMS)
Be aware of the risk of NMS, a potentially life-threatening condition that may occur when medications like this one are stopped abruptly or the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered thinking, rapid or abnormal heartbeat, or excessive sweating.
Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication to both you and your baby.
Restless Leg Syndrome
If you are taking this medication for restless leg syndrome, notify your doctor if your symptoms worsen or occur earlier in the day.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Orthostatic hypotension
- Dyskinesia
- Hallucinations
- Confusion
- Sedation
- Psychotic behavior
What to Do:
Remove the patch immediately. Provide supportive care. Monitor vital signs and mental status. If symptoms are severe or persistent, call 911 or your local emergency number. For general overdose information, call Poison Control at 1-800-222-1222.
Drug Interactions
Major Interactions
Moderate Interactions
- Antihypertensives: May increase risk of orthostatic hypotension when co-administered with rotigotine.
- Other drugs that cause somnolence.
Monitoring
Baseline Monitoring
Blood Pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation
Heart Rate
Rationale: To assess for baseline cardiac status.
Timing: Prior to initiation
Psychiatric History (e.g., psychosis, impulse control disorders)
Rationale: To identify predisposition to psychiatric adverse effects.
Timing: Prior to initiation
Sleep History (e.g., excessive daytime sleepiness, sleep attacks)
Rationale: To identify predisposition to somnolence.
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 limits, monitor for significant drops.
Action Threshold: Symptomatic orthostatic hypotension or sustained significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.
Mental Status/Behavioral Changes (e.g., hallucinations, delusions, impulse control disorders)
Frequency: Regularly, at each follow-up visit.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Development of new or worsening hallucinations, delusions, confusion, or compulsive behaviors (e.g., gambling, hypersexuality, binge eating, compulsive shopping).
Somnolence/Sleep Attacks
Frequency: Regularly, at each follow-up visit.
Target: Absence of excessive daytime sleepiness or sudden onset of sleep.
Action Threshold: Reports of sudden sleep onset during daily activities or significant increase in daytime somnolence.
Dyskinesia (in Parkinson's Disease)
Frequency: Regularly, at each follow-up visit.
Target: Minimize or control dyskinesia.
Action Threshold: Development or worsening of troublesome dyskinesia.
Application Site Reactions
Frequency: Patient self-monitoring daily, clinician review at visits.
Target: Minimal to no skin irritation.
Action Threshold: Severe erythema, edema, vesicles, papules, or persistent pruritus at application site.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness upon standing)
- Hallucinations (visual, auditory)
- Delusions
- Confusion
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness
- Sudden onset of sleep (sleep attacks)
- Dyskinesia (involuntary movements)
- Nausea
- Vomiting
- Peripheral edema
- Application site reactions (redness, itching, swelling, blistering)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at 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.
Lactation
Rotigotine inhibits prolactin secretion and may suppress lactation. It is unknown if rotigotine is excreted in human milk. 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:
Potential for inhibition of lactation and unknown risk of direct drug exposure to infant. Avoid or use with caution.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
Elderly patients (âĨ65 years) may be at increased risk for certain adverse reactions, particularly hallucinations, orthostatic hypotension, and peripheral edema. Initiate at the lowest effective dose and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Counsel patients extensively on proper patch application and rotation to minimize skin irritation and ensure consistent drug delivery.
- Emphasize the importance of removing the old patch before applying a new one to avoid overdose.
- Warn patients about the risk of sudden sleep attacks and advise caution with activities requiring mental alertness, especially during initiation and dose titration.
- Educate patients and caregivers about the potential for impulse control disorders and other psychiatric side effects, encouraging prompt reporting.
- Advise patients to avoid external heat sources (e.g., heating pads, hot baths) over the patch site, as this can lead to increased absorption and adverse effects.
- Rotigotine patch is a 24-hour continuous delivery system, providing stable plasma concentrations, which may help reduce 'wearing off' effects seen with oral medications.
Alternative Therapies
- For Parkinson's Disease: Levodopa/carbidopa, other dopamine agonists (e.g., pramipexole, ropinirole), MAO-B inhibitors (e.g., rasagiline, selegiline), COMT inhibitors (e.g., entacapone).
- For Restless Legs Syndrome: Other dopamine agonists (e.g., pramipexole, ropinirole), alpha-2 delta ligands (e.g., gabapentin, pregabalin), opioids (for severe refractory cases).
Cost & Coverage
Average Cost:
Varies widely, typically high per patch (e.g., box of 30 patches)
Insurance Coverage:
Tier 3 or higher (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.