Neupro 2mg/24hr TD Patch
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
Drug Class
Antiparkinsonian agent, Restless Legs Syndrome agent
Pharmacologic Class
Dopamine agonist
Pregnancy Category
Category C
FDA Approved
Apr 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Rotigotine is a medication used to treat Parkinson's disease and Restless Legs Syndrome. It comes as a patch that you apply to your skin once a day. It works by acting like a natural chemical in your brain called dopamine, which helps control movement and other functions.
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 is 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 schedule.
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 proper adhesion.
When applying the patch, press it firmly in place for 30 seconds to secure it.
Be cautious when bathing or showering to avoid dislodging the patch. If the patch falls off, replace it with a new one. If the patch loosens, use tape only on the edges to hold it in place.
When 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. Do not stop using the medication without consulting your doctor.
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 are 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 is 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 is 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 schedule.
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 proper adhesion.
When applying the patch, press it firmly in place for 30 seconds to secure it.
Be cautious when bathing or showering to avoid dislodging the patch. If the patch falls off, replace it with a new one. If the patch loosens, use tape only on the edges to hold it in place.
When 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. Do not stop using the medication without consulting your doctor.
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 are 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 is 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 once every 24 hours to a clean, dry, hairless area of skin on your stomach, thigh, hip, side, shoulder, or upper arm. Rotate application sites daily to minimize skin irritation.
- Do not apply the patch to skin that is red, irritated, or broken.
- Remove the old patch before applying a new one.
- Avoid applying heat (e.g., heating pads, hot baths, saunas) directly over the patch, as this can increase drug absorption and side effects.
- Remove the patch before undergoing an MRI (Magnetic Resonance Imaging) or cardioversion, as the aluminum backing can cause skin burns.
- Be aware that this medication can cause drowsiness or sudden sleep onset. Avoid driving or operating machinery until you know how it affects you.
- Alcohol and other sedatives can increase drowsiness. Use with caution.
- Stand up slowly from a sitting or lying position to reduce dizziness from low blood pressure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initial 2 mg/24hr patch once daily, titrated weekly by 2 mg/24hr increments. For Restless Legs Syndrome: Initial 1 mg/24hr patch once daily, titrated weekly by 1 mg/24hr increments.
Dose Range:
1 - 16 mg
Condition-Specific Dosing:
Parkinson's Disease:
Typical effective dose 4-8 mg/24hr, maximum 16 mg/24hr.
Restless Legs Syndrome:
Typical effective dose 1-3 mg/24hr, maximum 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 required.
Moderate:
No dose adjustment required.
Severe:
Use with caution. Consider lower starting dose and slower titration. Monitor for adverse effects.
Dialysis:
Use with caution. Rotigotine is not dialyzable. Consider lower starting dose and slower titration. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
Use with caution. Consider lower starting dose and slower titration. Monitor for adverse effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Rotigotine is a non-ergoline dopamine agonist that stimulates D2, D3, and D1 dopamine receptors. Its precise mechanism of action in Parkinson's disease and Restless Legs Syndrome is unknown but is thought to be related to its ability to stimulate dopamine receptors in the brain.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 37% (oral, not applicable to patch delivery rate)
Tmax:
15-24 hours (plasma concentration after patch application)
FoodEffect:
No clinically significant food effect for transdermal patch.
Distribution:
Vd:
Approximately 84 L/kg
ProteinBinding:
Approximately 92%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 5-7 hours (plasma elimination half-life)
Clearance:
Approximately 10-13 L/hr/kg (total body clearance)
ExcretionRoute:
Urine (approximately 71%), feces (approximately 23%)
Unchanged:
<10% (in urine)
Confidence:
Medium
Pharmacodynamics
OnsetOfAction:
Gradual (due to transdermal delivery)
PeakEffect:
Not precisely defined due to continuous delivery, but steady-state plasma concentrations are reached within 1-2 days of patch application.
DurationOfAction:
24 hours (due to continuous transdermal delivery)
Confidence:
Medium
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor 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, seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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)
Feeling confused
Fever
Muscle pain
Muscle stiffness
Trouble controlling body movements (new or worsening)
Changes in eyesight
Changes in sex interest
This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. Inform your doctor if you experience any of these symptoms.
Some people have reported falling asleep suddenly during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects or any other unusual symptoms, seek medical attention:
Constipation
Diarrhea
Vomiting
Upset stomach
Decreased appetite
Dizziness
Sleepiness
Fatigue
Weakness
Vivid or unusual dreams
Headache
Excessive sweating
Sleep disturbances
Joint pain
Irritation at the injection site (if applicable)
Dry mouth
* Nose or throat irritation
This list is not exhaustive. If you have questions or concerns about side effects, consult 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, seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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)
Feeling confused
Fever
Muscle pain
Muscle stiffness
Trouble controlling body movements (new or worsening)
Changes in eyesight
Changes in sex interest
This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. Inform your doctor if you experience any of these symptoms.
Some people have reported falling asleep suddenly during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness or fall asleep during activities, do not drive or engage in tasks that require alertness. Contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects or any other unusual symptoms, seek medical attention:
Constipation
Diarrhea
Vomiting
Upset stomach
Decreased appetite
Dizziness
Sleepiness
Fatigue
Weakness
Vivid or unusual dreams
Headache
Excessive sweating
Sleep disturbances
Joint pain
Irritation at the injection site (if applicable)
Dry mouth
* Nose or throat irritation
This list is not exhaustive. If you have questions or concerns about side effects, consult 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:
- Feeling dizzy or lightheaded, especially when standing up (orthostatic hypotension)
- Seeing or hearing things that are not there (hallucinations)
- Unusual urges or behaviors, such as compulsive gambling, increased sexual urges, compulsive shopping, or binge eating
- Falling asleep suddenly during daily activities
- Severe skin irritation, redness, swelling, or blistering at the patch site
- New or worsening involuntary movements (dyskinesia)
- Swelling in your 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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that 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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this 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 engaging in activities 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 down position, and exercise caution when climbing stairs.
Monitoring and Maintenance
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Allergy Considerations
If you have a sulfite allergy, consult your doctor, as some products may contain sulfites.
Medical Procedures and Devices
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 stop taking this drug, 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 Sources and Temperature Regulation
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 Reactions and Sun Exposure
If you experience a skin rash or irritation 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)
NMS is a rare but potentially life-threatening condition that may occur when medications like this one are stopped abruptly or when the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, inform your doctor, as adjustments to your treatment may be necessary.
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 engaging in activities 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 down position, and exercise caution when climbing stairs.
Monitoring and Maintenance
Follow your doctor's instructions for monitoring your blood pressure and heart rate.
Allergy Considerations
If you have a sulfite allergy, consult your doctor, as some products may contain sulfites.
Medical Procedures and Devices
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 stop taking this drug, 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 Sources and Temperature Regulation
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 Reactions and Sun Exposure
If you experience a skin rash or irritation 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)
NMS is a rare but potentially life-threatening condition that may occur when medications like this one are stopped abruptly or when the dose is lowered. Seek immediate medical attention if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, rapid or abnormal heartbeat, or excessive sweating.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Restless Leg Syndrome
If your symptoms worsen or occur earlier in the day, inform your doctor, as adjustments to your treatment may be necessary.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Orthostatic hypotension
- Hallucinations
- Confusion
- Agitation
- Dyskinesia
- Sedation
What to Do:
Remove the patch immediately. Seek emergency medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
Moderate Interactions
- Antihypertensive agents: May potentiate orthostatic hypotensive effects.
- Other drugs that cause somnolence or dizziness.
Confidence Interactions
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To establish baseline and monitor for orthostatic hypotension.
Timing: Prior to initiation of therapy.
Psychiatric history and current mental status
Rationale: To assess for pre-existing psychiatric conditions and monitor for new or worsening impulse control disorders, hallucinations, or psychosis.
Timing: Prior to initiation of therapy.
Sleep history
Rationale: To assess for pre-existing sleep disorders and monitor for sudden onset of sleep.
Timing: Prior to initiation of therapy.
Motor function assessment (for PD)
Rationale: To establish baseline motor symptoms and assess therapeutic response.
Timing: Prior to initiation of therapy.
Routine Monitoring
Orthostatic Blood Pressure (BP)
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal limits, avoid symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.
Psychiatric symptoms (e.g., hallucinations, delusions, impulse control disorders)
Frequency: Regularly, at each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of impulse control disorders, hallucinations, or psychosis.
Sleep patterns and daytime somnolence
Frequency: Regularly, at each visit.
Target: Maintain normal sleep-wake cycle, absence of sudden sleep onset.
Action Threshold: Reports of sudden sleep onset or excessive daytime sleepiness.
Application site reactions
Frequency: Daily by patient, periodically by clinician.
Target: Minimal to no irritation.
Action Threshold: Severe erythema, edema, vesicles, or persistent pruritus at application site.
Motor symptoms (for PD)
Frequency: Regularly, at each visit.
Target: Improvement in motor symptoms without excessive dyskinesia.
Action Threshold: Worsening of PD symptoms or development of troublesome dyskinesia.
Symptom Monitoring
- Dizziness or lightheadedness upon standing (orthostatic hypotension)
- Hallucinations or delusions
- Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness or sudden onset of sleep
- Nausea or vomiting
- Swelling in legs or feet (peripheral edema)
- Application site redness, itching, or blistering
- Worsening of Parkinson's symptoms or new involuntary movements (dyskinesia)
Special Patient Groups
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
Rotigotine is excreted in rat milk, and it is unknown if it is excreted in human milk. Dopamine agonists can inhibit lactation. Due to the potential for serious adverse reactions in breastfed infants and the inhibition of lactation, 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:
Moderate risk (L3). Potential for central nervous system effects (e.g., somnolence, decreased feeding) and inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
Use with caution in elderly patients, as they may be more susceptible to adverse reactions such as hallucinations, orthostatic hypotension, and somnolence. Start with the lowest effective dose and titrate slowly.
Clinical Information
Clinical Pearls
- Counsel patients extensively on the potential for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and sudden onset of sleep. These can occur without warning.
- Emphasize the importance of rotating patch application sites daily to minimize skin irritation. Advise patients to avoid applying the patch to the same site for at least 14 days.
- Instruct patients to remove the patch before MRI or cardioversion due to the aluminum layer in the patch, which can cause burns.
- Rotigotine patches should not be cut. If a lower dose is needed, a lower strength patch should be prescribed.
- Patients should be advised to avoid external heat sources (e.g., heating pads, hot baths, saunas) over the patch, as this can increase drug absorption and adverse effects.
- Titration should be slow and gradual to minimize adverse effects, especially orthostatic hypotension and somnolence.
Alternative Therapies
- Other dopamine agonists (e.g., pramipexole, ropinirole, apomorphine)
- Levodopa/carbidopa (for Parkinson's Disease)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
- For Restless Legs Syndrome: gabapentin, pregabalin, iron supplementation (if iron deficient)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 30 patches
Insurance Coverage:
Tier 2 or 3 (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 check with your pharmacist for more information. If you have any questions or concerns about this medication, consult 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 details about the overdose, including the medication taken, the amount, and the time it occurred.