Rotigotine

What is Rotigotine?

• Rotigotine (NEUPRO) is a dopamine agonist used for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS).

Rotigotine

Rotigotina

What are the uses of this medicine?

NEUPRO is used for the treatment of:

• Parkinson's disease
• Moderate-to-severe primary Restless Legs Syndrome

How does this medicine work?

• Rotigotine (roe tig' oh teen) is a synthetic dopamine agonist that is used to treat Parkinson disease and restless leg syndrome.
• Rotigotine is a nonselective agonist of dopamine receptors with highest affinity for the D3 class of receptors.
• It is structurally unrelated to ergot derivatives.
• Rotigotine is formulated as a transdermal patch which allows for once daily application and provides longer lasting and sustained plasma levels in comparison to other, oral non-ergot dopamine receptor agonists, such as ropinirole and pramipexole which are usually administered several times daily.
• In multiple placebo controlled clinical trials, rotigotine improved motor and daily activity scores in patients with Parkinson disease and in restless leg syndrome.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to rotigotine or any of the ingredients in NEUPRO.

What drug interactions can this medicine cause?

• Avoid coadministration with Dopamine antagonists, such as antipsychotics or metoclopramide. They may diminish the effectiveness of NEUPRO.

Is this medicine FDA approved?

• Rotigotine was approved for this use in the United States in 2007.

How should this medicine be used?

Recommended dosage: 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.

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.

Administration:

• Use NEUPRO exactly as your doctor tells you to use it.
• NEUPRO comes in 4 different size (dose) patches for Parkinson's disease. Your doctor should start you on a low dose of NEUPRO. Your doctor will change the dose weekly until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach the dose that controls your symptoms best.
• Apply NEUPRO 1 time each day at the same time each day.
• You may bathe, shower, or swim while wearing a NEUPRO patch. Water may loosen your NEUPRO patch.
• If the edges of the patch lift, you may tape them down with bandaging tape.
• If your NEUPRO patch falls off, apply a new NEUPRO patch for the rest of the day. The next day, apply a new patch at your regular time.
• If you miss a dose or forget to change your NEUPRO patch, apply a new NEUPRO patch as soon as you remember. Replace the NEUPRO patch at your normal time the next day.
• Do not stop using NEUPRO without talking to your doctor first. If your doctor tells you to stop using NEUPRO, you should ask your doctor for specific instructions on how to slowly and safely discontinue using NEUPRO. If you stop using NEUPRO, you may have withdrawal symptoms.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Transdermal System: 1 mg/24 hours, 2 mg/24 hours, 3 mg/24 hours, 4 mg/24 hours, 6 mg/24 hours, and 8 mg/24 hours of rotigotine.

This medicine is available in fallowing brand namesː

• NEUPRO

What side effects can this medication cause?

The most common side effects of this medicine include: The most common side effects of NEUPRO for Parkinson's disease may include:

• nausea
• vomiting
• somnolence
• application site reactions
• dizziness
• anorexia
• disturbances in initiating and maintaining sleep
• hyperhidrosis
• visual disturbance
• peripheral edema
• dyskinesia

The most common side effects of NEUPRO for Restless Legs Syndrome:

• application site reactions
• nausea
• disturbances in initiating and maintaining sleep
• somnolence
• headache

NEUPRO can cause serious side effects, including:

• severe allergic reactions
• falling asleep during normal activities
• hallucinations and other psychosis
• changes in blood pressure
• fainting
• unusual urges
• changes in heart rate
• increased weight and fluid retention
• uncontrolled, sudden movements
• skin site reactions
• withdrawal symptoms

What special precautions should I follow?

• NEUPRO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• Do not drive, operate machinery, or do other dangerous activities until you know how NEUPRO affects you.
• Avoid exposing the site where you have applied your NEUPRO patch to heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and direct sunlight. Too much medicine could be absorbed into your body.
• Do not use NEUPRO during certain medical procedures called magnetic resonance imaging (MRI) or cardioversion. Using NEUPRO during these procedures could cause a burn to the site where you applied your NEUPRO patch.
• Avoid direct sunlight if you get a skin rash or irritation from NEUPRO until your skin heals. Sun exposure could lead to skin color changes.
• Hallucinations/psychosis and dyskinesia may occur.
• Symptomatic postural hypotension and syncope may occur, especially during dose escalation.
• Elevation of blood pressure and heart rate may occur.
• Application site reactions can occur and may be severe.
• Hyperpyrexia and confusion may occur with sudden discontinuation or dose reduction.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• hypotension
• involuntary movements
• hallucinations
• confusion
• convulsions
• other signs of excessive dopaminergic stimulation

Treatment of overdosage:

• There is no known antidote for overdosage of dopamine agonists. In case of suspected overdose, the excess transdermal system(s) should immediately be removed from the patient. Concentrations of rotigotine decrease after patch removal.
• The patient's heart rate, heart rhythm, and blood pressure should be monitored.
• As shown in a study of renally impaired patients, dialysis is not expected to be beneficial.
• Treatment of overdose may require general supportive measures to maintain vital signs.
• If it is necessary to discontinue use of rotigotine after overdose, it should be discontinued gradually to prevent hyperpyrexia and confusion.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of NEUPRO in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients for any indication have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: rotigotine
• Inactive ingredients: ascorbyl palmitate, povidone, silicone adhesive, sodium metabisulfite, and dl-alpha-tocopherol.

Who manufactures and distributes this medicine?

Manufactured for: UCB, Inc. Smyrna, GA

• Neupro® is a registered trademark of the UCB Group of Companies.

What should I know about storage and disposal of this medication?

• Store NEUPRO at 68°F to 77°F (20°C to 25°C).
• Store NEUPRO in its original sealed pouch until use. Do not store NEUPRO outside of the pouch.

• Dailymed label info on Rotigotine
• FDA Rotigotine

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