Rotigotine patch package insert

Find helpful information and the tools you need to get started, here. See full prescribing information for other components of the formulation. Rotigotine transdermal patch neupro lifecycle strategy analysis. Press patch firmly in place for 30 seconds when putting it on. Polyester film, siliconized, aluminized, colour coated with a pigment titanium dioxide e171, pigment yellow 95, pigment red 166 layer and. See full prescribing information for other components of the formulation exelon. For nonprescription products, read the label or package ingredients carefully. Rotigotine transdermal route description and brand names. Initially, 2 mg24 hours for earlystage disease or 4 mg24 hours for advancedstage disease.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Rotigotine may also be used for purposes not listed in this medication guide. Importance of using the rotigotine transdermal system patch as prescribed. Neupro nu pro rotigotine transdermal system if you have restless legs syndrome also known as willisekbom disease, read this side. Rotigotine neupro is a new nonergolinic dopamine agonist transdermal patch that can be applied once daily.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In the us, neupro rotigotine transdermal system is indicated for the treatment of parkinsons disease. Not to exceed 6 mg24 hr patch qday for earlystage disease or 8 mg24 hr for advancedstage disease. Rotigotine dosage restless legs syndrome home page. Rotigotine is a nonergotderived dopamine agonist that is used to relieve the symptoms of parkinsons disease.

It is a dopamine agonist that helps improve muscle control and reduce muscle stiffness to allow more normal movements of the body. Jan 07, 2019 rotigotine transdermal skin patch is used to treat symptoms of parkinsons disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Rotigotine side effects, dosage, interactions drugs. It is formulated as a patch applied to the skin for 24 hours, during which time about 45% of the rotigotine in the patch is released. Downloading fda package insert for neupro extended release patch. Neupro rotigotine transdermal system is a prescription medicine used to treat parkinsons disease and moderatetosevere primary restless legs syndrome. Neupro rotigotine dosing, indications, interactions. Neupro is a medication with the proven potential for rls symptom relief. Rotigotine patches neupro for parkinsons disease nps.

This emedtv page gives some details on when and how to apply these patches and takes a look. Rotigotine is a dopamine agonist approved for use for the treatment of signs and symptoms of idiopathic parkinsons disease pd in addition to moderate to severe restless legs syndrome rls. Regulatory strategy 33 package insert dosage form the neupro transdermal patch is a thin, matrixtype transdermal delivery system tds consisting of three layers. To date, it is approved for the treatment of early parkinsons disease as monotherapy and has been shown to be effective in the treatment of advancedstage parkinsons disease and restless legs syndrome in several clinical trials. The prescribed dose may be achieved using single or multiple patches.

Rotigotine comes in the form of a patch and is applied once a day. Rotigotine transdermal skin patch is used to treat symptoms of parkinsons disease, such as stiffness, tremors, muscle spasms, and poor muscle control. If you miss a dose or forget to change your neupro patch, apply a new. Rotigotine is the only dopamine agonist available in patch formulation and provides a. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. About 45% of the rotigotine in the patch is released within 24 hours and steady state plasma concentrations are reached by 12 days. Information for the user neupro 4 mg24 h transdermal patch neupro 6 mg24 h transdermal patch neupro 8 mg24 h transdermal patch rotigotine read all of this leaflet carefully before you start using this medicine because it contains important information for you. Portions of this table adapted from neupro rotigotine package insert. This emedtv article discusses why companies are not allowed to make generic versions of neupro rotigotine. Apply the rotigotine patch at around the same time every day.

Rotigotine is also used to treat restless legs syndrome rls. Sinemet carbidopa levodopa is the first choice treatment for parkinsons disease. Jan 25, 2011 rotigotine is a dopamine agonist administered by transdermal patch and is currently approved for the treatment of early and advanced stage parkinsons disease and restless legs syndrome in europe. Once the patch is removed, plasma concentrations decrease with a terminal halflife of 57 hours. Udpglucuronosyltransferases catalyze the metabolism of rotigotine see drug interactions. Transdermal patches for the treatment of neurologic. Upon discontinuation, reduce the daily dose by a maximum of 1 mg every 24 hours, if possible. Patient information neupro nu pro rotigotine transdermal. It is covered by more medicare and insurance plans, but some pharmacy coupons or cash prices may be lower. Do not use this medicine after the expiry date which is stated on the label and box. With neupro, your rls symptoms are treated with one patch, once a day. This emedtv page gives some details on when and how to apply these patches and takes a look at how your individual rotigotine dosage is determined.

Then apply a new neupro patch the next day at your regular time. Rotigotine is a dopamine agonist that works by helping to restore the balance of a certain natural substance dopamine in the brain. There are currently no generic alternatives to neupro. Neupro rotigotine is an effective treatment for parkinsons disease or restless legs syndrome, but can cause troublesome sideeffects related to impulse control. In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0. If the patch loosens, put tape only on the edges of the patch to hold it in place.

If you need to stop rotigotine, you will want to slowly stop it as ordered by your doctor. It is a patch that delivers the dopamine agonist rotigotine through the skin. If you have parkinsons disease, read the other side. These medicines treat a variety of conditions across several therapeutic categories. Rotigotine medicinal forms bnf content published by nice. After removal of the patch, plasma levels decreased with a. Feb 05, 2019 drinking alcohol can increase certain side effects of rotigotine. The dose may be increased as needed by 2 mg24 hours at weekly intervals, up to 6 mg 24 hours for earlystage disease and up to 8 mg24 hours for advancedstage disease. Be careful to not knock loose the patch while bathing or showering. This patient package insert and instructions for use has been approved by the u. Oct 29, 20 regulatory strategy 33 package insert dosage form the neupro transdermal patch is a thin, matrixtype transdermal delivery system tds consisting of three layers. It is formulated as a oncedaily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Rotigotine is the only dopamine agonist available in patch formulation and provides a steady blood level of drug over 24 hours. Do not stop taking rotigotine all of a sudden without calling your doctor.

The neupro patch may burn your skin if you wear the patch during an mri magnetic resonance imaging. Manufacturer advises apply patch to clean, dry, intact, healthy and nonirritated skin on torso, thigh, hip, shoulder or upper arm by pressing the patch firmly against the skin for about 30 seconds. Take a few minutes to watch this video on how to apply the neupro patch. This article lists other possible effects and describes how these problems may be treated. Neupro may cause hallucinations the sensation of hearing or seeing something that is not there, most commonly among elderly people. As this selection from the emedtv web library explains, using too much neupro rotigotine may cause involuntary movements, confusion, or other problems. Highlights of prescribing information these highlights do not include all the information needed to use exelon safely and effectively. If you have moderatetosevere primary rls and are experiencing uncomfortable sensations anytime youre trying to sleep, relax, or just sit still, neupro rotigotine transdermal system may be right for you. Transdermal technology mylan strives to design, develop and manufacture high quality, innovative transdermal drugdelivery systemsadhesive patches that deliver medication through the skin. Patches should be removed after 24 hours and the replacement patch applied on a different area avoid using the same area for 14 daysconsult. Rotigotine is a dopamine agonist administered by transdermal patch and is currently approved for the treatment of early and advanced stage parkinsons disease and restless legs syndrome in europe. These highlights do not include all the information needed to use neupro safely and effectively.

To discontinue treatment, reduce dose gradually no faster than 2 mg24 hr every other day until completely withdrawn. Rotigotine neupro is an expensive drug used to control the signs and symptoms of parkinsons disease or restless legs syndrome. Neupro is a prescription medicine used to treat parkinsons disease and. It also explains when a generic neupro might become available and describes circumstances that may come up to delay this date. Rotigotine transdermal patch is used to treat symptoms of parkinsons disease, sometimes called shaking palsy. After being extensively metabolised, rotigotine is mainly excreted in the urine as metabolites.

Highlights of prescribing information these highlights do not. Rotigotine, sold under the brand name neupro among others, is a dopamine agonist of the nonergoline class of medications indicated for the treatment of parkinsons disease pd and restless legs syndrome rls. Jan 04, 2019 this patient package insert and instructions for use has been approved by the u. The following day, apply a new patch at your regular time. Highlights of prescribing information these highlights do. Treatment of moderatetosevere primary restless legs syndrome. Rotigotine is the only dopamine agonist available in patch formulation and. Drinking alcohol can increase certain side effects of rotigotine. Transdermal rotigotine comes as a patch to apply to the skin. Rotigotine is also used to treat a condition called restless legs syndrome rls. Appropriate studies have not been performed on the relationship of age to the effects of rotigotine transdermal patch in the pediatric population. On average, approximately 45% of the rotigotine from the patch is released. If you forget to apply a neupro patch at the usual time, remove the used neupro patch you are currently wearing and put on a new neupro patch on a different area of skin. Refer patients to instructions for use in the patient.