Neupro

(Generic versions may still be available.)

DRUG DESCRIPTION

Neupro® (Rotigotine Transdermal System) is a transdermal delivery system that provides rotigotine, a non-ergolinic dopamine agonist. When applied to intact skin, Neupro (rotigotine transdermal system) is designed to continuously deliver rotigotine over a 24-hour period.

The chemical name of rotigotine is (6S)-6-{propyl[2-(2-thienyl)ethyl]amino}-5,6,7,8-tetrahydro-1-naphthalenol. The empirical formula is C19H25NOS. The molecular weight is 315.48. The structural formula for rotigotine is:

Neupro® (Rotigotine Transdermal System) structural formula illustration

The asterisk designates the chiral center.

Neupro (rotigotine transdermal system) is available in three strengths: 2, 4, and 6 mg/24 hours. Each transdermal system has a release surface area of 10, 20, and 30 cm2 and contains 4.5, 9, or 13.5 mg rotigotine, respectively. See Table 1. The composition of the transdermal system per area unit is identical.

Table 1 Transdermal System Size, Drug Content, and Nominal Delivery Rate

Neupro Nominal Dose Rotigotine Content per System Neupro System Size
2 mg/24 hours 4.5 mg 10 cm2
4 mg/24 hours 9 mg 20 cm2
6 mg/24 hours 13.5 mg 30 cm2

System Components and Structure

Neupro (rotigotine transdermal system) is a thin, matrix-type transdermal system composed of three layers:

System Components and Structure

Backing film
Drug matrix
Protective liner

  1. A flexible, tan-colored backing film, consisting of an aluminized polyester film coated with a pigment-layer on the outer side. The backing provides structural support and protection of the drug-loaded adhesive layer from the environment.
  2. A self-adhesive drug matrix layer, consisting of the active component rotigotine and the following inactive components: ascorbyl palmitate, povidone, silicone adhesive, sodium metabisulfite, and dl-alpha-tocopherol.
  3. A protective liner, consisting of a transparent fluoropolymer-coated polyester film. This liner protects the adhesive layer during storage and is removed just prior to application.

What are the possible side effects of rotigotine (Neupro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • nausea, sweating, feeling light-headed, fainting;
  • breathing problems;
  • severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure;
  • hallucinations;
  • ...

Read All Potential Side Effects and See Pictures of Neupro »

What are the precautions when taking rotigotine transdermal system (Neupro)?

Consult your...

Read All Potential Precautions of Neupro »


Neupro Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Neupro Patient Information Including Side Effects

Brand Names: Neupro

Generic Name: rotigotine (transdermal) (Pronunciation: roe TIG oh teen)

  • What is rotigotine (Neupro)?
  • What are the possible side effects of rotigotine (Neupro)?
  • What is the most important information I should know about rotigotine (Neupro)?
  • What should I discuss with my health care provider before using rotigotine (Neupro)?
  • How should I use rotigotine (Neupro)?
  • What happens if I miss a dose (Neupro)?
  • What happens if I overdose (Neupro)?
  • What should I avoid while using rotigotine (Neupro)?
  • What other drugs will affect rotigotine (Neupro)?
  • Where can I get more information?

What is rotigotine (Neupro)?

Rotigotine has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Rotigotine is used to treat early signs and symptoms of Parkinson's disease.

Rotigotine may also be used for purposes other than those listed in this medication guide.

Rotigotine skin patches were withdrawn from the U.S. market in April 2008.

What are the possible side effects of rotigotine (Neupro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • nausea, sweating, feeling light-headed, fainting;
  • breathing problems;
  • severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure;
  • hallucinations;
  • swelling in your hands or feet; or
  • restless muscle movements in your eyes, tongue, jaw, or neck.

Less serious side effects may include:

  • weight gain;
  • swelling, redness, or itching where the patch was applied.
  • urinating more than usual;
  • runny nose;
  • diarrhea, loss of appetite;
  • feeling dizzy, tired, or weak;
  • mild drowsiness or sleepiness;
  • headache;
  • sleep problems (insomnia);
  • blurred vision; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rotigotine (Neupro)?

Rotigotine skin patches were withdrawn from the U.S. market in April 2008.

Do not stop using rotigotine without first talking to your doctor. You may need to use less and less before you stop using the patches completely. Stopping suddenly can cause fever, stiff muscles, confusion, sweating, and fast or uneven heartbeats.

Rotigotine may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

Call your doctor at once if you have serious side effects such as extreme drowsiness, falling asleep suddenly, breathing problems, severe or sudden headache, hallucinations, chest pain, swelling, fainting, or restless muscle movements in your eyes, tongue, jaw, or neck.

You may have increased sexual urges, intense or unusual urges to gamble, or other intense urges while taking rotigotine. Talk with your doctor if you believe you have any intense or unusual urges while you are using rotigotine.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

The rotigotine transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

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