Neupro 4mg/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?
Neupro is a patch that delivers a medicine called rotigotine through your skin. 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 symptoms of Restless Legs Syndrome, like an irresistible urge to move your legs.
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 patches that are damaged.
Before and after handling the patch, wash your hands thoroughly.
Apply the patch to clean, dry, 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 skin that is irritated, damaged, or has skin 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 applying the patch.
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 careful not to dislodge the patch while bathing or showering.
If the patch falls off, replace it with a new one as soon as possible.
If the patch loosens, use tape only on the edges of the patch 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, avoiding storage in a bathroom.
Keep 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 location where children and pets cannot access it.
Missed 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's essential to follow the instructions carefully to ensure safe and effective use.
Do not cut or divide the patches, and do not use patches that are damaged.
Before and after handling the patch, wash your hands thoroughly.
Apply the patch to clean, dry, 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 skin that is irritated, damaged, or has skin 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 applying the patch.
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 careful not to dislodge the patch while bathing or showering.
If the patch falls off, replace it with a new one as soon as possible.
If the patch loosens, use tape only on the edges of the patch 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, avoiding storage in a bathroom.
Keep 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 location where children and pets cannot access it.
Missed 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 one new patch once every 24 hours to a clean, dry, hairless area of skin on the torso, thigh, or upper arm. Rotate application sites daily to prevent skin irritation.
- Do not apply 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) to the patch site, as this can increase drug absorption.
- Remove the patch before an MRI, cardioversion, or diathermy due to the aluminum layer in the patch.
- Be aware of potential sudden sleep attacks; avoid driving or operating machinery if you experience excessive sleepiness.
- Monitor for and report any new or worsening compulsive behaviors (e.g., gambling, shopping, eating, sexual urges) to your doctor.
- Do not stop the patch abruptly without consulting your doctor, as this can lead to withdrawal symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initial 2 mg/24hr patch, titrated weekly by 2 mg/24hr increments. Maintenance dose typically 4-8 mg/24hr for early PD, up to 16 mg/24hr for advanced PD. For Restless Legs Syndrome: Initial 1 mg/24hr patch, titrated weekly by 1 mg/24hr increments. Maintenance dose typically 1-3 mg/24hr.
Dose Range:
1 - 16 mg
Condition-Specific Dosing:
Parkinson's Disease (Early):
4-8 mg/24hr
Parkinson's Disease (Advanced):
8-16 mg/24hr
Restless Legs Syndrome:
1-3 mg/24hr
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Consider dose reduction for patients with severe renal impairment (CrCl < 30 mL/min). Max dose 4 mg/24hr for PD, 2 mg/24hr for RLS.
Dialysis:
Consider dose reduction. Max dose 4 mg/24hr for PD, 2 mg/24hr for RLS. Rotigotine is not removed by dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Consider dose reduction for patients with moderate hepatic impairment (Child-Pugh B). Max dose 4 mg/24hr for PD, 2 mg/24hr for RLS.
Severe:
Consider dose reduction for patients with severe hepatic impairment (Child-Pugh C). Max dose 4 mg/24hr for PD, 2 mg/24hr for RLS.
Pharmacology
Mechanism of Action
Rotigotine is a non-ergoline dopamine agonist that acts as a full agonist at D3, D2, 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:
6-12 hours (after patch application)
FoodEffect:
Not applicable (transdermal)
Distribution:
Vd:
84 L/kg
ProteinBinding:
92%
CnssPenetration:
Yes
Elimination:
HalfLife:
5-7 hours
Clearance:
Not available (systemic clearance is high)
ExcretionRoute:
Urine (71%), Feces (23%)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Gradual (due to transdermal delivery)
PeakEffect:
Not precisely defined for clinical effect, but steady-state plasma concentrations are reached within 2-3 days of continuous patch application.
DurationOfAction:
24 hours (with continuous patch application)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Strong, uncontrollable urges (such as excessive eating, gambling, sex, or spending)
Chest pain or pressure
Rapid or irregular heartbeat
New or worsening mental, mood, or behavioral changes
Hallucinations (seeing or hearing things that are not there)
Confusion
Fever
Muscle pain or stiffness
Difficulty controlling body movements (new or worsening)
Changes in vision
Changes in sex drive
This medication may also cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you experience any of these symptoms, inform your doctor.
In rare cases, people have fallen asleep suddenly while engaging in activities like driving, eating, or talking, sometimes without feeling drowsy 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 perform tasks that require alertness. Contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects or any other symptoms that bother you or do not subside, consult your doctor:
Constipation, diarrhea, vomiting, or stomach upset
Decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Vivid or unusual dreams
Headache
Excessive sweating
Sleep disturbances
Joint pain
Irritation at the site of administration
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, 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 immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Strong, uncontrollable urges (such as excessive eating, gambling, sex, or spending)
Chest pain or pressure
Rapid or irregular heartbeat
New or worsening mental, mood, or behavioral changes
Hallucinations (seeing or hearing things that are not there)
Confusion
Fever
Muscle pain or stiffness
Difficulty controlling body movements (new or worsening)
Changes in vision
Changes in sex drive
This medication may also cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you experience any of these symptoms, inform your doctor.
In rare cases, people have fallen asleep suddenly while engaging in activities like driving, eating, or talking, sometimes without feeling drowsy 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 perform tasks that require alertness. Contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects or any other symptoms that bother you or do not subside, consult your doctor:
Constipation, diarrhea, vomiting, or stomach upset
Decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Vivid or unusual dreams
Headache
Excessive sweating
Sleep disturbances
Joint pain
Irritation at the site of administration
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, 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 (signs of orthostatic hypotension)
- New or worsening hallucinations (seeing or hearing things that aren't there)
- Unusual urges or behaviors (e.g., compulsive gambling, increased sexual urges, uncontrolled shopping or eating)
- Falling asleep suddenly during daily activities
- Severe skin irritation, blistering, or swelling at the patch site
- Unexplained swelling in the legs or ankles
- Confusion or disorientation
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose 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.
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 stop using 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 Irritation and Sun Exposure
If you experience a skin rash or irritation from the patch, avoid exposing the affected area to sunlight until the skin has healed, as sun exposure may cause changes in skin 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 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 appear 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 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 stop using 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 Irritation and Sun Exposure
If you experience a skin rash or irritation from the patch, avoid exposing the affected area to sunlight until the skin has healed, as sun exposure may cause changes in skin 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 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 appear earlier in the day, inform your doctor, as adjustments to your treatment may be necessary.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Orthostatic hypotension
- Dyskinesia (involuntary movements)
- Hallucinations
- Confusion
- Sedation
- Psychotic behavior
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Remove the patch immediately. Supportive measures and symptomatic treatment are indicated. There is no known antidote.
Drug Interactions
Major Interactions
Moderate Interactions
- Antihypertensives: May increase the 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 orthostatic hypotension risk.
Timing: Before initiation
Mental Status/Psychiatric History
Rationale: To assess for pre-existing psychiatric conditions or risk factors for impulse control disorders/hallucinations.
Timing: Before initiation
Skin integrity at potential application sites
Rationale: To ensure suitable sites for patch application and minimize irritation.
Timing: Before 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.
Psychiatric symptoms (e.g., hallucinations, delusions, impulse control disorders like pathological gambling, hypersexuality, compulsive shopping, binge eating)
Frequency: Regularly, at each visit, and with patient/caregiver education.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of these symptoms requires dose reduction or discontinuation.
Somnolence/Sleep attacks
Frequency: Regularly, at each visit.
Target: Absence of excessive daytime sleepiness or sudden sleep onset.
Action Threshold: Reported somnolence or sleep attacks, especially while driving or performing hazardous activities.
Application site reactions
Frequency: Regularly, at each visit, and with patient education.
Target: Minimal to no skin irritation.
Action Threshold: Severe erythema, edema, pruritus, or blistering at application site.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness upon standing)
- Hallucinations
- Delusions
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Excessive daytime sleepiness
- Sudden onset of sleep
- Nausea
- Vomiting
- Peripheral edema
- Application site reactions (redness, itching, swelling, blistering)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on embryo-fetal development.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies.
Second Trimester:
Potential for developmental toxicity observed in animal studies.
Third Trimester:
Potential for developmental toxicity observed in animal studies; theoretical risk of inhibiting lactation.
Lactation
Not recommended. Rotigotine may inhibit lactation due to its dopamine agonist activity. It is unknown if rotigotine is excreted in human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Unknown; potential for adverse effects on the infant due to drug exposure and potential inhibition of lactation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to adverse effects such as hallucinations, orthostatic hypotension, and somnolence. Monitor closely.
Clinical Information
Clinical Pearls
- Ensure patients understand proper patch application and rotation to minimize skin reactions. Advise them to press firmly for 30 seconds to ensure good adhesion.
- Emphasize the importance of removing the old patch before applying a new one to avoid overdose.
- Counsel patients and caregivers about the risk of impulse control disorders and sudden sleep attacks, as patients may not recognize these symptoms themselves.
- Rotigotine patches contain an aluminum layer; patients must remove the patch before MRI, cardioversion, or diathermy to prevent skin burns.
- Abrupt discontinuation of rotigotine can lead to a neuroleptic malignant syndrome-like syndrome or withdrawal symptoms (e.g., apathy, anxiety, depression, fatigue, sweating, pain). Taper dose gradually over several days to weeks.
- Heat exposure (e.g., hot baths, saunas, heating pads) can increase the rate and extent of rotigotine absorption, potentially leading to overdose symptoms.
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 RLS: Gabapentin enacarbil, pregabalin, opioids (last resort)
Cost & Coverage
Average Cost:
Varies widely, typically several hundred dollars per 30 patches
Insurance Coverage:
Tier 2 or 3 (Specialty 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 occurred.