Neupro 8mg/24hr TD Patch

Manufacturer UCB PHARMA Active Ingredient Rotigotine(roe TIG oh teen) Pronunciation roe TIG oh teen
It is used to treat Parkinson's disease.It is used to treat restless leg syndrome.
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Drug Class
Antiparkinsonian agent
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Pharmacologic Class
Dopamine agonist (non-ergot)
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Pregnancy Category
C
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FDA Approved
Apr 2007
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Neupro is a patch that you stick on your skin once a day. It contains a medicine called rotigotine, which works like a natural chemical in your brain called dopamine. This helps to improve the symptoms of Parkinson's disease, like tremors and stiffness, or the uncomfortable urges to move your legs in Restless Legs Syndrome.
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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. Adhere to 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, 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.
When applying the patch, press it firmly in place for 30 seconds to ensure secure adhesion.
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 immediately.
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 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.
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Lifestyle & Tips

  • Apply the patch to a clean, dry, hairless area of skin on your stomach, thigh, hip, flank, shoulder, 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.
  • Be cautious when standing up quickly, especially from a sitting or lying position, to avoid dizziness or fainting due to low blood pressure.
  • Avoid driving or operating machinery if you experience excessive sleepiness or sudden sleep attacks.
  • Limit or avoid alcohol consumption, as it can increase drowsiness.
  • Discuss any new or unusual urges or behaviors (e.g., gambling, shopping, eating, sexual urges) with your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: For Parkinson's Disease: Initial dose 2 mg/24hr patch, increased by 2 mg/24hr weekly to a maximum of 8 mg/24hr. Some patients may benefit from doses up to 16 mg/24hr. For Restless Legs Syndrome: Initial dose 1 mg/24hr patch, increased by 1 mg/24hr weekly to a maximum of 3 mg/24hr.
Dose Range: 1 - 16 mg

Condition-Specific Dosing:

Parkinson's Disease: Initial: 2 mg/24hr, increase by 2 mg/24hr weekly to 8 mg/24hr. Max: 16 mg/24hr.
Restless Legs Syndrome: Initial: 1 mg/24hr, increase by 1 mg/24hr weekly to 3 mg/24hr.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: For Parkinson's Disease: Max dose 6 mg/24hr. For Restless Legs Syndrome: Max dose 2 mg/24hr.
Dialysis: Not studied in patients on dialysis. Use with caution, consider lower maximum doses as in severe renal impairment.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
Moderate: For Parkinson's Disease: Max dose 6 mg/24hr. For Restless Legs Syndrome: Max dose 2 mg/24hr.
Severe: Not studied. Use with caution, consider lower maximum doses as in moderate hepatic impairment.

Pharmacology

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Mechanism of Action

Rotigotine is a non-ergoline dopamine agonist. It is believed to exert its therapeutic effects by stimulating D2, D3, and D1 dopamine receptors in the brain. The precise mechanism of action in Parkinson's disease is unknown but is thought to be related to its ability to stimulate postsynaptic dopamine D2-type receptors in the caudate-putamen. For Restless Legs Syndrome, the mechanism is also unknown but is thought to involve the dopaminergic system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45% (due to first-pass metabolism)
Tmax: 6-12 hours (for steady-state plasma concentrations after patch application)
FoodEffect: Not applicable (transdermal administration)

Distribution:

Vd: 84 L/kg (high volume of distribution)
ProteinBinding: Approximately 92% (primarily to albumin)
CnssPenetration: Yes

Elimination:

HalfLife: 5-7 hours (terminal half-life)
Clearance: Approximately 10-17 L/hr
ExcretionRoute: Renal (approximately 60% as metabolites), Fecal (approximately 30% as metabolites)
Unchanged: Less than 10% (in urine)
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Pharmacodynamics

OnsetOfAction: Gradual (due to transdermal delivery and titration)
PeakEffect: Achieved after several days of continuous patch application and dose titration.
DurationOfAction: 24 hours (with continuous patch application)
Confidence: High

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Chest pain or pressure
Fast or abnormal heartbeat
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Feeling confused
Fever
Muscle pain
Muscle stiffness
Trouble controlling body movements (new or worsening)
Changes in eyesight
Changes in sex interest
Swelling, weight gain, or trouble breathing (this medication may cause fluid retention)

Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they didn't feel sleepy beforehand. This can occur up to 1 year after starting the medication. If you fall asleep during activities or feel extremely sleepy, do not drive or engage in tasks that require alertness. Contact your doctor immediately if this happens.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical help:

Constipation
Diarrhea
Vomiting
Upset stomach
Decreased appetite
Dizziness
Sleepiness
Fatigue
Weakness
Strange or vivid dreams
Headache
Excessive sweating
Trouble sleeping
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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting spells
  • Sudden onset of sleep during daily activities
  • Hallucinations (seeing or hearing things that aren't there)
  • Unusual urges or behaviors (e.g., uncontrollable gambling, increased sexual urges, compulsive shopping or eating)
  • New or worsening confusion or psychotic-like behavior
  • Severe skin reactions at the patch site (e.g., blistering, swelling, severe rash)
  • Swelling in the legs or ankles
  • Unexplained muscle pain or tenderness
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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 drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness 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.
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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.

To ensure your safety, 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 exercise caution when climbing stairs.

Regularly 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 it is crucial to remove it before undergoing an MRI or cardioversion procedure.

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 instructions for tapering off the medication. Be aware of potential withdrawal symptoms, 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.

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.

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 lead to excessive medication absorption. Also, avoid prolonged, hot baths or sunbathing.

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 the irritated skin to change color.

Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur when medications like this one are stopped abruptly or the dose is lowered. If you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or abnormal heartbeat, or excessive sweating, contact your doctor immediately.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

Specific Considerations for Restless Leg Syndrome

Inform your doctor if your symptoms worsen or occur earlier in the day.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Orthostatic hypotension
  • Dyskinesia (involuntary movements)
  • Hallucinations
  • Confusion
  • Sedation
  • Psychotic behavior

What to Do:

Remove the patch immediately. Provide supportive care. Monitor vital signs and mental status. Gastric lavage is not indicated for transdermal overdose. There is no specific antidote. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; antiemetics like metoclopramide): May reduce the efficacy of rotigotine.
  • Sedatives/CNS depressants (e.g., benzodiazepines, opioids, alcohol): May potentiate sedative effects.
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Moderate Interactions

  • Antihypertensives: May increase the risk of orthostatic hypotension.
  • Other drugs that cause somnolence or dizziness.

Monitoring

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Baseline Monitoring

Blood pressure (orthostatic)

Rationale: To assess baseline risk for orthostatic hypotension, a common side effect of dopamine agonists.

Timing: Before initiation and during dose titration.

Cardiac function (ECG)

Rationale: To rule out underlying cardiac conditions that could be exacerbated by hypotensive effects or rarely, QT prolongation (though not a primary concern with rotigotine).

Timing: Before initiation (especially in patients with cardiac risk factors).

Mental status/Psychiatric history

Rationale: To assess baseline for impulse control disorders, hallucinations, or psychosis, which can be exacerbated or induced by dopamine agonists.

Timing: Before initiation.

Skin integrity

Rationale: To identify suitable application sites and assess for pre-existing skin conditions.

Timing: Before initiation.

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Routine Monitoring

Blood pressure (orthostatic)

Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.

Target: Maintain within patient's normal range, avoid symptomatic drops.

Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) or significant drop (e.g., >20 mmHg systolic, >10 mmHg diastolic) upon standing.

Mental status/Behavioral changes (e.g., impulse control disorders, hallucinations, psychosis)

Frequency: At each follow-up visit, inquire about new or worsening symptoms.

Target: Absence of new or worsening psychiatric symptoms.

Action Threshold: Development of new or worsening impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), hallucinations, delusions, or psychotic behavior.

Application site reactions

Frequency: Daily by patient, at each follow-up visit by clinician.

Target: Minimal to no redness, itching, or irritation.

Action Threshold: Severe or persistent erythema, edema, pruritus, or blistering at the application site.

Peripheral edema

Frequency: At each follow-up visit.

Target: Absence of new or worsening edema.

Action Threshold: Development of significant peripheral edema.

Sleep patterns (e.g., somnolence, sleep attacks)

Frequency: At each follow-up visit.

Target: Maintain normal sleep-wake cycle, absence of sudden sleep onset.

Action Threshold: Excessive daytime sleepiness or sudden onset of sleep during daily activities.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting spells (syncope)
  • Nausea
  • Vomiting
  • Constipation
  • Swelling in legs/ankles (edema)
  • Hallucinations
  • Delusions
  • Confusion
  • Unusual urges or behaviors (e.g., gambling, shopping, eating, sexual urges)
  • Excessive daytime sleepiness
  • Sudden onset of sleep
  • Application site redness, itching, swelling, blistering, or pain
  • Worsening of Parkinson's symptoms or RLS symptoms (if applicable)

Special Patient Groups

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Pregnancy

Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on embryo-fetal development at doses higher than clinical exposure.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies at high doses.
Second Trimester: Potential for developmental toxicity observed in animal studies at high doses.
Third Trimester: Potential for developmental toxicity observed in animal studies at high doses; theoretical risk of affecting fetal dopamine regulation.
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Lactation

L3 (Moderate risk). It is not known whether rotigotine is excreted in human milk. Rotigotine or its metabolites were excreted in the milk of lactating rats. 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.

Infant Risk: Potential for central nervous system effects (e.g., sedation, irritability) and interference with infant dopamine regulation. Monitor infant for adverse effects.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in this population.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustments for renal or hepatic impairment may be more frequently needed in the elderly.

Clinical Information

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Clinical Pearls

  • Neupro patches should be applied once every 24 hours and removed before applying a new one. Do not wear more than one patch at a time.
  • Rotate application sites daily to minimize skin irritation. Avoid applying to the same site for at least 14 days.
  • Patients should be advised about the potential for sudden onset of sleep and impulse control disorders, and to report these symptoms immediately.
  • Titration is crucial for both Parkinson's disease and RLS indications to minimize side effects and find the optimal therapeutic dose.
  • If discontinuing treatment, rotigotine should be tapered gradually to avoid withdrawal symptoms (e.g., akinetic crisis, hyperpyrexia, confusion), especially in Parkinson's patients.
  • Application site reactions are common but usually mild to moderate. Severe reactions warrant discontinuation and medical evaluation.
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Alternative Therapies

  • Other dopamine agonists (oral): Pramipexole (Mirapex), Ropinirole (Requip), Apomorphine (Apokyn - injectable)
  • Levodopa/Carbidopa (Sinemet, Rytary, Duopa)
  • MAO-B inhibitors (e.g., Selegiline, Rasagiline, Safinamide)
  • COMT inhibitors (e.g., Entacapone, Tolcapone, Opicapone)
  • Amantadine
  • Anticholinergics (e.g., Benztropine, Trihexyphenidyl)
  • For RLS: Gabapentin enacarbil (Horizant), Pregabalin (Lyrica), Iron supplementation (if iron deficient)
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Cost & Coverage

Average Cost: Varies widely, typically $500-$1500+ per 30 patches (1 month supply)
Insurance Coverage: Tier 2 or 3 (Specialty/Non-preferred Brand)
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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 your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.