"The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, an"...
(Generic versions may still be available.)
Parkinson's Disease (PD)
The effectiveness of Neupro was demonstrated in randomized, controlled trials in patients with early-stage Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced-stage Parkinson's disease on concomitant levodopa.
Restless Legs Syndrome (RLS)
Neupro (Rotigotine Transdermal System) is indicated for the treatment of moderate-to-severe primary restless legs syndrome.
DOSAGE AND ADMINISTRATION
Neupro is applied once a day. The adhesive side of the transdermal system should be applied to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The transdermal system should be applied at approximately the same time every day, at a convenient time for the patient. Because Neupro is administered transdermally, food is not expected to affect absorption and it can be applied irrespective of the timing of meals. No dosage adjustment is necessary for patients who have moderate impairment of hepatic function or mild to severe impairment of renal function. The application site for Neupro should be moved on a daily basis (for example, from the right side to the left side and from the upper body to the lower body). Neupro should not be applied to the same application site more than once every 14 days and should not be placed on skin that is oily, irritated, or damaged, or where it will be rubbed by tight clothing. If it is necessary to apply Neupro to a hairy area, the area should be shaved at least 3 days prior to Neupro application. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place for 30 seconds, making sure there is good contact, especially around the edges. If the patient forgets to replace Neupro, or if the transdermal system becomes dislodged, another transdermal system should be applied for the remainder of the day. The prescribed dose may be achieved using single or multiple patches. [Refer Patients to Instructions for Use in the Patient Information Section at the end of the Full Prescribing Information].
Early-Stage Parkinson's Disease
Neupro should be started at 2 mg/24 hours for patients with early-stage Parkinson's disease. Based upon individual patient clinical response and tolerability, Neupro dosage may be increased weekly by 2 mg/24 hours if tolerated and if additional therapeutic effect is needed. The lowest effective dose was 4 mg/24 hours. The highest recommended dose for early-stage Parkinson's disease is 6 mg/24 hours.
Advanced-Stage Parkinson's Disease
Patients with advanced-stage Parkinson's disease may be initiated at 4 mg/24 hours. Based upon individual patient clinical response and tolerability, Neupro dosage may be increased weekly by 2 mg/24 hours. The recommended dose for advanced-stage Parkinson's disease is 8 mg/24 hours.
Restless Legs Syndrome
Neupro should be started at 1 mg/24 hours. Based upon individual patient clinical response and tolerability, Neupro dosage may be increased weekly by 1 mg/24 hours if tolerated and if additional therapeutic effect is needed. The lowest effective dose was 1 mg/24 hours. The highest recommended dose is 3 mg/24 hours.
Discontinuation of Treatment
For patients with Parkinson's disease, the daily dose should be reduced by a maximum of 2 mg/24 hours with a dose reduction preferably every other day, until complete withdrawal of Neupro is achieved.
For patients with RLS, the daily dose should be reduced by 1 mg/24 hours preferably every other day, until complete withdrawal of Neupro is achieved.
Dosage Forms And Strengths
Transdermal System: 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg rotigotine per 24 hours.
Storage And Handling
Each transdermal system is packaged in a separate pouch.
Each strength is available in cartons of 30 transdermal systems.
1 mg/24 hours 30 transdermal
systems NDC #50474-801-03
2 mg/24 hours 30 transdermal systems NDC #50474-802-03
3 mg/24 hours 30 transdermal systems NDC #50474-803-03
4 mg/24 hours 30 transdermal systems NDC #50474-804-03
6 mg/24 hours 30 transdermal systems NDC #50474-805-03
8 mg/24 hours 30 transdermal systems NDC #50474-806-03
Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]
Neupro should be stored in the original pouch. Do not store outside of pouch.
Apply the transdermal system immediately upon removal from the pouch. Discard used systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.
Manufactured for: UCB, Inc. Smyrna, GA 30080 Made in Germany 1E. Revised: 04/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/13/2012
Additional Neupro Information
Neupro - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.