Neupro 6mg/24hr TD Patch
Overview
What is this medicine?
How to Use This Medicine
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 patches that are damaged.
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 placing the patch on 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 application to ensure proper adhesion.
When applying the patch, press it firmly in place for 30 seconds to secure it.
Rotate the patch site with each new patch, and avoid using 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 as soon as possible.
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 medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep the patches in their pouch until ready for use.
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 to clean, dry, intact skin on your torso, thigh, hip, shoulder, or upper arm. Rotate the application site daily to prevent skin irritation.
- Remove the old patch before applying a new one. Do not apply to skin that is red, irritated, or has been treated with creams or lotions.
- Avoid external heat sources (e.g., heating pads, electric blankets, hot baths, saunas) over 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 heavy machinery if you experience excessive sleepiness.
- Monitor for unusual urges or behaviors, such as increased gambling, shopping, or sexual urges, and report them to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Strong, uncontrollable urges (such as 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or if they persist or bother you, contact your doctor:
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
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Sudden onset of sleep during daily activities
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality, compulsive shopping, binge eating)
- Severe dizziness or fainting spells
- Significant or persistent skin irritation, redness, swelling, or blistering at the patch application site
- Worsening of Parkinson's or RLS symptoms
- Unexplained swelling in the ankles or feet
Before Using This Medicine
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 drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This will help your doctor and pharmacist assess potential interactions and ensure safe use.
All your health problems, as certain conditions may affect the safety or efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & 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 down position, and be cautious 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 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 drug absorption. If you experience a skin rash or irritation from the patch, avoid sunlight on the affected area until the skin has healed, as sun exposure 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 when 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
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.
Restless Leg Syndrome
If you are taking this medication for restless leg syndrome, inform your doctor if your symptoms worsen or occur earlier in the day.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Orthostatic hypotension
- Hallucinations
- Dyskinesia (involuntary movements)
- Confusion
- Excessive sedation
- Psychotic behavior
What to Do:
In case of suspected overdose, immediately remove the patch(es). Seek emergency medical attention or call Poison Control at 1-800-222-1222. Management is supportive, including maintaining vital signs and gastric lavage if oral ingestion occurred (though unlikely with patch). Dopamine antagonists may be considered if CNS stimulation is severe, but may worsen Parkinson's symptoms.
Drug Interactions
Major Interactions
- Dopamine antagonists (e.g., antipsychotics like phenothiazines, butyrophenones, thioxanthenes; metoclopramide): May reduce the efficacy of rotigotine.
- CNS depressants (e.g., sedatives, hypnotics, alcohol): May enhance the sedative effects of rotigotine.
Moderate Interactions
- Antihypertensive medications: May cause additive hypotensive effects, increasing the risk of orthostatic hypotension.
Monitoring
Baseline Monitoring
Rationale: To assess baseline cardiovascular status and risk for orthostatic hypotension.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline cardiovascular status.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline for impulse control disorders, hallucinations, delusions, and somnolence.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline for somnolence and sudden sleep onset.
Timing: Prior to initiation of therapy.
Rationale: To identify suitable application sites and assess for pre-existing skin conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal limits, minimize symptomatic drops.
Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, fainting) or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.
Frequency: Regularly, at each follow-up visit.
Target: Absence of new or worsening impulse control disorders, hallucinations, delusions, confusion.
Action Threshold: Development or worsening of impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, delusions, or confusion.
Frequency: Regularly, at each follow-up visit.
Target: Maintain alertness appropriate for daily activities.
Action Threshold: Excessive daytime sleepiness, falling asleep during activities of daily living (e.g., driving, eating, conversing).
Frequency: Daily by patient, regularly by clinician.
Target: Minimal to no irritation, erythema, or pruritus.
Action Threshold: Severe or persistent erythema, edema, vesicles, papules, or other signs of significant skin irritation at the patch site.
Frequency: Regularly, at each follow-up visit.
Target: Improvement in motor symptoms (PD) or RLS symptoms (RLS) with acceptable tolerability.
Action Threshold: Lack of therapeutic response or worsening of symptoms.
Symptom Monitoring
- Orthostatic hypotension (dizziness, lightheadedness, fainting upon standing)
- Somnolence (excessive daytime sleepiness)
- Sudden sleep onset (falling asleep without warning)
- Hallucinations (seeing or hearing things that aren't there)
- Delusions (false beliefs)
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Dyskinesia (involuntary movements, especially in PD patients)
- Nausea, vomiting
- Application site reactions (redness, itching, swelling, rash at patch site)
- Peripheral edema
Special Patient Groups
Pregnancy
Rotigotine is classified as 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:
Lactation
It is not known whether rotigotine is excreted in human milk. However, animal studies have shown excretion of rotigotine-related material into milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing 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.
Pediatric Use
The safety and effectiveness of Neupro in pediatric patients have not been established. Use is not recommended.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the adverse effects of dopamine agonists, such as hallucinations, orthostatic hypotension, and somnolence. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Instruct patients to apply the patch to a different site each day and not to reuse the same site for at least 14 days to minimize skin irritation.
- The patch should be applied once every 24 hours and worn continuously for 24 hours. It should be removed and a new patch applied at a different site at approximately the same time each day.
- Patients should be advised not to cut the patch, as this can affect drug release.
- Counsel patients and caregivers about the risk of impulse control disorders and sudden sleep attacks, as patients may not recognize these symptoms themselves.
- If a patient experiences severe application site reactions, consider discontinuing the patch and exploring alternative therapies.
- When discontinuing rotigotine, especially in Parkinson's disease, a gradual dose reduction is recommended to avoid withdrawal symptoms (e.g., akinetic crisis, hyperpyrexia, confusion).
Alternative Therapies
- For Parkinson's Disease: Levodopa/carbidopa, other dopamine agonists (e.g., pramipexole, ropinirole, apomorphine), MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide), COMT inhibitors (e.g., entacapone, opicapone), amantadine, anticholinergics (e.g., benztropine, trihexyphenidyl).
- For Restless Legs Syndrome: Other dopamine agonists (e.g., pramipexole, ropinirole), gabapentin enacarbil, iron supplementation (if iron deficient).