Generic Name: rotigotine (roe-TIG-oh-teen)
Brand Name: Neupro
Rotigotine is used for:
Treating Parkinson disease. It is also used for the treatment of moderate to severe restless legs syndrome (RLS).
Rotigotine is a dopamine agonist. Exactly how it works is not known. It is thought to work in certain areas of the brain to reduce the symptoms (eg, uncontrolled muscle movements) of RLS and the early stages of Parkinson disease.
Do NOT use rotigotine if:
- you are allergic to any ingredient in rotigotine
Contact your doctor or health care provider right away if any of these apply to you.
Before using rotigotine:
Some medical conditions may interact with rotigotine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have blood vessel problems, high or low blood pressure, liver problems, kidney problems, asthma or other lung or breathing problems, fluid retention or swelling, mental or mood problems (eg, bipolar disorder, schizophrenia), drowsiness, unexpected or unpredictable sleepiness or periods of sleep, or a sleep disorder (eg, daytime sleepiness)
- if you have or have had heart problems (eg, heart failure)
- if you feel dizzy, nauseated, sweaty, or faint when you stand up
- if you drink alcohol or have had a personal or family history of addiction (eg, gambling, alcohol)
- if you are scheduled to have magnetic resonance imaging (MRI) or a procedure to treat an irregular heartbeat (cardioversion)
Some MEDICINES MAY INTERACT with rotigotine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Benzodiazepines (eg, diazepam), medicines for mental or mood problems (eg, antidepressants, antipsychotics), or medicines for sleep (eg, zolpidem) because the risk of severe drowsiness may be increased
- Dopamine antagonists, such as phenothiazines (eg, chlorpromazine) or metoclopramide because they may decrease rotigotine's effectiveness
- Levodopa because the risk of its side effects may be increased by rotigotine
This may not be a complete list of all interactions that may occur. Ask your health care provider if rotigotine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use rotigotine:
Use rotigotine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with rotigotine. Talk to your pharmacist if you have questions about this information.
- Apply rotigotine only to clean, dry, intact skin on the front of the stomach, thigh, hip, side of the body between the ribs and hip, shoulder, or upper arm as directed by your doctor or on the package labeling.
- Do not apply rotigotine to hairy, oily, red, irritated, or damaged skin or where it will be rubbed by tight clothing or under a waistband. Do not apply to skin folds. If you must apply rotigotine to a hairy area of skin, shave the hair from the area at least 3 days before you apply rotigotine to that area.
- Do not apply creams, lotions, ointments, oils, or powders to the skin where the patch will be applied. Never cut or tear the patch.
- To use rotigotine, gently wash the application site with soap and warm water. Rinse until all soap is removed. Dry the area with a clean, dry towel.
- Remove the patch from its sealed pouch and peel away one side of the protective liner. Apply the sticky side of the patch to the skin immediately after opening the pouch. Peel away the rest of the liner so that the patch lies flat against the skin. There should be no bumps or folds in the patch. Press the patch against your skin firmly with the palm of your hand for 30 seconds to make sure there is good contact with the skin, especially around the edges.
- Wash your hands thoroughly with soap and water after applying rotigotine. Do not touch your eyes until after you have washed your hands.
- After 24 hours, remove the used patch and fold it in half with the sticky sides together. Discard out of the reach of children and away from pets. Wash the area with mild soap and warm water to remove any adhesive remaining on the skin. Baby or mineral oil may also be used to remove adhesive. Do not use alcohol or nail polish remover to remove adhesive. Apply a new patch to a different area of skin. Use a new application site each time you apply a new patch. Do not apply a patch to the same area of skin within 14 days.
- You may bathe, shower, or swim while wearing your patch.
- Do not suddenly stop using rotigotine without checking with your doctor. You may have an increased risk of side effects (eg, fever; confusion; muscle stiffness, pain, or weakness; kidney problems). If you need to stop rotigotine, your doctor should gradually lower your dose.
- Apply rotigotine 1 time each day at about the same time to get the most benefit from it.
- Continue to use rotigotine even if you feel well. Do not miss any doses.
- If the edges of your patch lift, you may tape them down with bandaging tape. If your patch falls off, apply a new patch for the rest of the day.
- If you miss a dose of rotigotine or forget to change your patch, remove the old patch and apply a new patch to a different area of skin. Then change the patch according to your regular dosing schedule. Do not wear 2 patches at once.
Ask your health care provider any questions you may have about how to use rotigotine.
Important safety information:
- Rotigotine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use rotigotine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using rotigotine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Some people who use rotigotine may experience sudden onset of severe drowsiness or may even fall asleep during normal daily activities (eg, eating, talking, driving). This could occur without warning. Some of these events have been reported as late as one year after rotigotine was started. If this happens, do not drive, operate machinery, or perform other possibly unsafe tasks while you use rotigotine. Tell your doctor right away.
- Do not use more than the recommended dose or stop using rotigotine without checking with your doctor.
- Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using rotigotine or other medicines used to treat Parkinson disease. Tell your doctor right away if you notice such effects.
- Rotigotine may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not apply heating pads, electric blankets, or other such sources of heat to the area where you apply rotigotine. Avoid other sources of heat such as heat lamps; saunas; hot tubs; heated waterbeds; long, hot baths; or prolonged, direct exposure to sunlight while using rotigotine. Heat may increase the amount of rotigotine released into your skin.
- Tell your doctor or dentist that you take rotigotine before you receive any medical or dental care, emergency care, or surgery.
- Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if rotigotine also increases the risk of melanoma. You may need to have skin exams while you are using rotigotine. Discuss any questions or concerns with your doctor.
- In patients with RLS, rotigotine may cause RLS symptoms to come back or become worse or start earlier in the day. Discuss any questions or concerns with your doctor.
- This product contains a sulfite (sodium metabisulfite). Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you ever have had an allergic reaction to sulfites, contact your doctor.
- Remove rotigotine from the skin before you have certain medical tests or treatments (eg, MRI, cardioversion). It may become hot and cause burns if left on the skin during such procedures.
- If you have a skin rash or irritation from the patch, avoid direct sunlight on the area until the skin heals. Exposure to sunlight could lead to skin color changes.
- Use rotigotine with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations or other mental or mood problems.
- Rotigotine should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using rotigotine while you are pregnant. It is not known if rotigotine is found in breast milk. Rotigotine may decrease milk production. If you are or will be breast-feeding while you use rotigotine, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of rotigotine:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased appetite; diarrhea; dizziness; drowsiness; headache; increased sweating; joint pain; minor redness, swelling, or itching at the application site; nausea; symptoms of upper respiratory tract infection (eg, cough, runny or stuffy nose, sneezing, sore throat); tiredness; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal dreams; burning, numbness, or tingling; chest pain; confusion; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; new or worsening mental or mood problems (eg, agitation, depression, paranoia); new or worsening uncontrolled, sudden movements of arms or legs; persistent irritation, itchiness, redness, or swelling at the application site; persistent trouble sleeping; ringing in the ears; severe or persistent dizziness, light-headedness, or headache; shortness of breath; sudden, severe drowsiness or falling asleep during normal daily activities; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; tremors; unusual skin growths or changes in the appearance of a mole; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; fainting; hallucinations; involuntary movements; nausea; seizures; severe dizziness or light-headedness; vomiting.Proper storage of rotigotine:
Store rotigotine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original sealed pouch until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep rotigotine out of the reach of children and away from pets.
- If you have any questions about rotigotine, please talk with your doctor, pharmacist, or other health care provider.
- Rotigotine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take rotigotine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about rotigotine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to rotigotine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using rotigotine.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.