Neupro 2 mg/24h
rotigotine · PATCH, EXTENDED RELEASE · UCB, Inc.
Neupro is a patch, extended release containing rotigotine at 2 mg/24h, taken transdermal. Manufactured by UCB, Inc..
Key Facts
- Brand Name
- Neupro
- Generic Name
- rotigotine
- NDC Code (Product)
50474-802- Manufacturer
- UCB, Inc.
- Strength
- 2 mg/24h
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- NDA021829
- Drug Class
- Nonergot Dopamine Agonist [EPC]
- Marketing Start
- 04/02/2012
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NEUPRO is a dopamine agonist indicated for the treatment of: Parkinson's disease ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome ( 1.2 ) 1.1 Parkinson's Disease (PD) NEUPRO is indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome (RLS) NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Parkinson's disease: Initially, 2 mg/24 hours for early-stage disease or 4 mg/24 hours for advanced-stage disease. The dose may be increased as needed by 2 mg/24 hours at weekly intervals, up to 6 mg/24 hours for early-stage disease and up to 8 mg/24 hours for advanced-stage disease. ( 2.1 ) Restless Legs Syndrome: Initially, 1 mg/24 hours, increased as needed by 1 mg/24 hours at weekly intervals, up to 3 mg/24 hours. ( 2.2 ) Apply once a day to the skin; press firmly in place for 30 seconds. Do not place NEUPRO on oily, irritated, or damaged skin, or where it will be rubbed by tight clothing. Do not use the same site more than once every 14 days. The prescribed dose may be achieved using single or multiple patches. ( 2.3 ) To discontinue treatment, reduce the dose gradually until complete withdrawal of NEUPRO. ( 2.4 ) 2.1 Dosage in Parkinson's Disease Early-Stage Parkinson's Disease In patients with early-stage Parkinson's disease, the recommended starting dose for NEUPRO is 2 mg/24 hours. Based upon individual patient clinical response and tolerability, NEUPRO dosage may be increased weekly by 2 mg/24 hours if additional therapeutic effect is needed. T…
Contraindications
4 CONTRAINDICATIONS NEUPRO is contraindicated in patients who have demonstrated hypersensitivity to rotigotine or the components of the transdermal system. History of hypersensitivity to rotigotine or components of the transdermal patch. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Dopamine Antagonists Dopamine antagonists, such as antipsychotics or metoclopramide, may diminish the effectiveness of NEUPRO [see Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Sulfite Sensitivity [see Warnings and Precautions (5.1) ] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.2) ] Hallucinations/Psychosis [see Warnings and Precautions (5.3) ] Symptomatic Hypotension [see Warnings and Precautions (5.4) ] Syncope [see Warnings and Precautions (5.5) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.6) ] Elevation of Blood Pressure and Heart Rate [see Warnings and Precautions (5.7) ] Weight Gain and Fluid Retention [see Warnings and Precautions (5.8) ] Dyskinesia [see Warnings and Precautions (5.9) ] Application Site Reactions [see Warnings and Precautions (5.10) ] Augmentation and Rebound in RLS [see Warnings and Precautions (5.11) ] Hyperpyrexia and Confusion [see Warnings and Precautions (5.14) ] Withdrawal Symptoms [see Warnings and Precautions (5.15) ] Fibrotic Complications [see Warnings and Precautions (5.16) ] Parkinson's disease: Most common adverse reactions (at least 5% greater than placebo) were nausea, vomiting, somnolence, application site reactions, dizziness,…
Frequently Asked Questions
What is Neupro used for?
Neupro contains rotigotine. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.
Is Neupro a controlled substance?
Neupro is not classified as a controlled substance by the DEA.
What is the generic name for Neupro?
The generic name for Neupro is rotigotine. There are no other listed brand versions of rotigotine.
What is the NDC code for Neupro 2 mg/24h?
The NDC (National Drug Code) for Neupro 2 mg/24h is 50474-802, listed by UCB, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)