Neupro 1mg/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
May 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Neupro is a skin patch that delivers a medicine called rotigotine. It works by acting like a natural brain chemical called dopamine. This helps to improve symptoms of Parkinson's disease, such as tremors and stiffness, and restless legs syndrome, which causes an irresistible urge to move your legs, especially at night.
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 the instructions carefully to ensure safe and effective use.
Do not cut or divide the patches, and do not use damaged patches.
Before and after handling the patch, 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.
Apply the patch at the same time every day to maintain a consistent routine.
Avoid applying the patch to irritated or damaged skin, skin folds, or 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.
When applying the patch, press it firmly in place for 30 seconds to ensure it adheres properly.
Rotate the patch site with each new patch, and avoid applying a new patch to the same site for 14 days.
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 secure it in place.
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.
Storage and Disposal
Store the patches at room temperature in a dry place, away from the bathroom.
Keep 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 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 the instructions carefully to ensure safe and effective use.
Do not cut or divide the patches, and do not use damaged patches.
Before and after handling the patch, 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.
Apply the patch at the same time every day to maintain a consistent routine.
Avoid applying the patch to irritated or damaged skin, skin folds, or 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.
When applying the patch, press it firmly in place for 30 seconds to ensure it adheres properly.
Rotate the patch site with each new patch, and avoid applying a new patch to the same site for 14 days.
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 secure it in place.
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.
Storage and Disposal
Store the patches at room temperature in a dry place, away from the bathroom.
Keep 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 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 daily at approximately the same time each day. Rotate the application site daily (e.g., abdomen, thigh, hip, flank, shoulder, upper arm) to avoid skin irritation. Do not apply to the same site for at least 14 days.
- Remove the old patch before applying a new one. Wash hands thoroughly after handling patches.
- Avoid applying heat (e.g., heating pads, hot baths, saunas) to the patch site, as this can increase drug absorption and lead to overdose.
- Be aware of potential for sudden sleep attacks or excessive drowsiness. Avoid driving or operating heavy machinery until you know how this medication affects you.
- Monitor for changes in behavior, such as increased gambling, shopping, or sexual urges. Report these to your doctor immediately.
- Do not stop using the patch suddenly without consulting your doctor, as this can lead to serious withdrawal symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Restless Legs Syndrome (RLS): Initial dose 1 mg/24hr transdermal patch once daily. For Parkinson's Disease (PD): Initial dose 2 mg/24hr transdermal patch once daily.
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial: 2 mg/24hr. Titrate weekly by 2 mg/24hr increments. Effective dose range: 4-8 mg/24hr. Max: 16 mg/24hr.
Restless Legs Syndrome:
Initial: 1 mg/24hr. Titrate weekly by 1 mg/24hr increments. Effective dose range: 1-3 mg/24hr. 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 needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed, but caution and close monitoring are recommended due to limited data.
Dialysis:
Not available; caution and close monitoring are recommended.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed, but caution and close monitoring are recommended due to limited data.
Pharmacology
Mechanism of Action
Rotigotine is a non-ergoline dopamine agonist. It is believed to exert its therapeutic effects by stimulating dopamine D2 and D3 receptors in the brain. The precise mechanism of action in Parkinson's disease and Restless Legs Syndrome is unknown, but it is thought to be related to its ability to stimulate postsynaptic dopamine receptors in the caudate-putamen in the brain.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 45% (oral, not directly applicable to transdermal patch). Transdermal absorption is continuous and sustained.
Tmax:
Plasma concentrations reach steady state within 1-2 days of patch application. Peak plasma concentrations (Cmax) are typically observed 6-12 hours after patch application.
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 84 L/kg
ProteinBinding:
Approximately 92% (primarily to human serum albumin and alpha-1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 5-7 hours (plasma elimination half-life after patch removal, but effective half-life from patch is longer due to sustained release)
Clearance:
Approximately 10-13 L/min (total plasma clearance)
ExcretionRoute:
Primarily renal (approximately 70%), followed by fecal (approximately 20%)
Unchanged:
<10% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours to days, with full therapeutic effect seen after titration to an effective dose (weeks).
PeakEffect:
Achieved after titration to an optimal dose, typically within 1-2 weeks for RLS and 3-4 weeks for PD.
DurationOfAction:
24 hours (due to continuous transdermal delivery)
Confidence:
Medium
Safety & Warnings
Side Effects
Serious 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 or 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 if this happens or if you feel extremely sleepy.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or persist, 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
Sleep disturbances
Joint pain
Irritation at the injection site (if applicable)
Dry mouth
* Nose or throat irritation
This is not an exhaustive list of possible side effects. 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, contact your doctor or 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 if this happens or if you feel extremely sleepy.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or persist, 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
Sleep disturbances
Joint pain
Irritation at the injection site (if applicable)
Dry mouth
* Nose or throat irritation
This is not an exhaustive list of possible side effects. 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:
- Severe dizziness or fainting (signs of low blood pressure)
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, compulsive shopping, binge eating)
- Excessive daytime sleepiness or sudden sleep attacks
- Severe skin irritation, blistering, or swelling at the patch site
- Swelling in the ankles or feet
- Confusion or agitation
- Muscle stiffness, high fever, or severe confusion (signs of neuroleptic malignant syndrome-like symptoms if stopped suddenly)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
An allergy to this medication or any of its components
An allergy to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, please disclose the following information to your doctor and pharmacist:
A list of all medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
An allergy to this medication or any of its components
An allergy to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, please disclose the following information to your doctor and pharmacist:
A list of all medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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.
Precautions and Safety Measures
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 position and exercise caution when climbing stairs.
Monitor your blood pressure and heart rate as instructed by your doctor.
If you have a sulfite allergy, consult your doctor, as some products may contain sulfites.
The patch may contain metal, so remove it before undergoing an MRI or cardioversion.
Discontinuing the Medication
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop the medication, follow your doctor's instructions for tapering off the dose.
Be aware of potential withdrawal symptoms, including fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
Interactions and Contraindications
Discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor before using them.
Avoid exposure to heat sources, such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds, as this may cause your body temperature to rise and increase the absorption of the medication.
Refrain from taking long, hot baths or sunbathing, and avoid exposing the patch site to direct sunlight, especially if you experience skin irritation or a rash.
Serious Potential Side Effects
Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening condition that may occur when medications like this one are stopped abruptly or the dose is lowered. Seek medical attention immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Restless Leg Syndrome
* If your symptoms worsen or occur earlier in the day, inform your doctor, as adjustments to your treatment plan 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.
Precautions and Safety Measures
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 position and exercise caution when climbing stairs.
Monitor your blood pressure and heart rate as instructed by your doctor.
If you have a sulfite allergy, consult your doctor, as some products may contain sulfites.
The patch may contain metal, so remove it before undergoing an MRI or cardioversion.
Discontinuing the Medication
Do not stop taking this medication without consulting your doctor, as this may lead to withdrawal symptoms. If you need to stop the medication, follow your doctor's instructions for tapering off the dose.
Be aware of potential withdrawal symptoms, including fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain. If you experience any of these symptoms when reducing the dose or stopping the medication, contact your doctor immediately.
Interactions and Contraindications
Discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor before using them.
Avoid exposure to heat sources, such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds, as this may cause your body temperature to rise and increase the absorption of the medication.
Refrain from taking long, hot baths or sunbathing, and avoid exposing the patch site to direct sunlight, especially if you experience skin irritation or a rash.
Serious Potential Side Effects
Neuroleptic malignant syndrome (NMS) is a rare but potentially life-threatening condition that may occur when medications like this one are stopped abruptly or the dose is lowered. Seek medical attention immediately if you experience fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Restless Leg Syndrome
* If your symptoms worsen or occur earlier in the day, inform your doctor, as adjustments to your treatment plan may be necessary.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Orthostatic hypotension (dizziness upon standing)
- Hallucinations
- Confusion
- Dyskinesia (involuntary movements)
- Agitation
- Sedation
What to Do:
Remove the patch immediately. Seek emergency medical attention or call Poison Control at 1-800-222-1222. Supportive measures and symptomatic treatment are recommended. There is no known antidote.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like haloperidol, phenothiazines; antiemetics like metoclopramide): May reduce the efficacy of rotigotine.
Monitoring
Baseline Monitoring
Blood pressure (sitting and standing)
Rationale: To assess for baseline orthostatic hypotension risk.
Timing: Prior to initiation of therapy.
Mental status/Psychiatric history
Rationale: To identify pre-existing psychiatric conditions or risk factors for impulse control disorders, hallucinations, or psychosis.
Timing: Prior to initiation of therapy.
Skin integrity
Rationale: To assess for any pre-existing skin conditions that may affect patch adhesion or increase irritation.
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, monitor for significant drops.
Action Threshold: Symptomatic orthostatic hypotension or sustained drop >20 mmHg systolic or >10 mmHg diastolic.
Mental status/Behavioral changes
Frequency: Regularly, at each follow-up visit.
Target: Absence of new or worsening psychiatric symptoms (e.g., hallucinations, delusions, impulse control disorders, psychosis).
Action Threshold: Development of new or worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, delusions, or psychosis. Consider dose reduction or discontinuation.
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 excessive daytime sleepiness or sudden sleep attacks. Advise caution with driving/operating machinery; consider dose reduction or discontinuation.
Application site reactions
Frequency: Regularly, at each follow-up visit and patient self-monitoring.
Target: Minimal to no skin irritation.
Action Threshold: Severe erythema, edema, vesicles, papules, or pruritus that persists or worsens. Advise site rotation; consider topical corticosteroids or discontinuation if severe.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness upon standing)
- Hallucinations (seeing or hearing things that aren't there)
- Delusions
- Psychosis
- Impulse control disorders (e.g., pathological gambling, increased libido, compulsive shopping, binge eating)
- Excessive daytime sleepiness
- Sudden onset of sleep (sleep attacks)
- Nausea
- Vomiting
- Peripheral edema (swelling of ankles/feet)
- Application site reactions (redness, itching, swelling, blistering at patch site)
- Withdrawal symptoms upon abrupt discontinuation (e.g., hyperpyrexia, confusion, severe akinesia, rigidity, autonomic instability)
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
It is not known whether rotigotine is excreted in human milk. Rotigotine inhibits prolactin secretion in humans and may inhibit 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:
Risk unknown; potential for adverse effects on the infant due to dopamine agonist activity and potential for inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence. Monitor closely.
Clinical Information
Clinical Pearls
- Ensure proper patch application and site rotation to minimize skin irritation and ensure consistent drug delivery. Patients should be instructed to apply the patch to clean, dry, intact skin and to press firmly for 30 seconds.
- Educate patients and caregivers about the potential for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) and sudden sleep attacks. These can occur without warning.
- Rotigotine patches contain an aluminum layer; patients should be advised to remove the patch before MRI or cardioversion to prevent skin burns.
- Abrupt discontinuation of rotigotine can lead to a withdrawal syndrome resembling neuroleptic malignant syndrome (fever, rigidity, altered mental status, autonomic instability). Taper dose gradually over several days to weeks.
- 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 lead to overdose.
Alternative Therapies
- Other dopamine agonists (e.g., pramipexole, ropinirole, apomorphine)
- Levodopa/carbidopa (for Parkinson's Disease)
- MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide - for Parkinson's Disease)
- COMT inhibitors (e.g., entacapone, opicapone - for Parkinson's Disease)
- Gabapentin enacarbil (for Restless Legs Syndrome)
- Iron supplementation (if iron deficiency is present for RLS)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 30 patches (1 month supply)
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription drug), may require prior authorization.
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 information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.