Description
Rotigotine transdermal patch is used to treat Parkinson disease. It is a dopamine agonist that works on the nervous system to help treat the symptoms of Parkinson disease.
Rotigotine is also used to treat a condition called Restless Legs Syndrome (RLS). RLS is a neurologic disorder that affects sensation and movement in the legs and causes the legs to feel uncomfortable. This results in an irresistible feeling of wanting to move your legs to make them comfortable.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Patch, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rotigotine transdermal patch in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rotigotine transdermal patch in the elderly. However, elderly patients are more likely to develop hallucinations (seeing, hearing, or feeling things that are not there), which may require caution in patients receiving this medicine.
Breastfeeding
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Sulpiride
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Haloperidol
- Metoclopramide
- Olanzapine
- Paliperidone
- Risperidone
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Congestive heart failure or
- Dyskinesia (trouble controlling your muscles) or
- Heart or blood vessel disease or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Kidney disease, severe or
- Mental illness (eg, hallucinations, psychosis)—Use with caution. May make these conditions worse.
- Lung or breathing problem (eg, asthma) or
- Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite, which may cause serious allergic reactions in patients with these conditions.
- Sleep disorders or
- Sleepiness, history of—May cause side effects to become worse.
Proper Use
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use the skin patch:
- Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
- Apply the patch to a clean, dry, intact, and healthy skin area on your stomach, thigh, hip, flank (side of the body between the ribs and the pelvis), shoulder, or upper arm. Choose an area that is not very oily, has little or no hair, and is free of scars, cuts, burns, or any other skin irritation. If you need to put the patch on a hairy area, the area should be shaved at least 3 days before applying the patch. Avoid putting the patch on skin folds, under a waistband, or on areas where it could be rubbed by tight clothing.
- Press the patch firmly in place with the palm of your hand for about 30 seconds. Make sure there is good contact with your skin, especially around the edges of the patch.
- The patch should stay in place, even when you are showering, bathing, or swimming. Apply a new patch if it falls off.
- After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put a new patch in the same place for at least 14 days. Do not leave the patch on for more than 24 hours. It will not work as well after that time and it may irritate your skin.
- After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Make sure to dispose of it out of the reach of children and pets. Wash the application site with soap and water to remove any drug or adhesive. You may also use baby or mineral oil to remove any excess medicine. Do not use alcohol or other solvents (eg, nail polish remover) to avoid skin irritation.
- Try to change the patch at the same time each day. If you forget to change the patch at the usual time, remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the usual time on the next day.
- Do not put cream, lotion, ointment, oil, or powder on the skin area where the patch will be placed.
- Make sure you wash your hands with soap and water before and after applying the patch.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For transdermal dosage form (patch):
- For Parkinson's disease:
- Adults—At first, one 2-milligram (mg) patch applied every 24 hours for early-stage disease or one 4-mg patch applied every 24 hours for advanced-stage disease. Your doctor will gradually increase your dose if needed and tolerated. However, the dose is usually not more than 6 to 8 mg every 24 hours.
- Children—Use and dose must be determined by your doctor.
- For Restless Legs Syndrome (RLS):
- Adults—At first, one 1-milligram (mg) patch applied every 24 hours. Your doctor will gradually increase your dose if needed and tolerated. However, the dose is usually not more than 3 mg every 24 hours.
- Children—Use and dose must be determined by your doctor.
- For Parkinson's disease:
Missed Dose
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Storage
Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause some people to become dizzy, drowsy, lightheaded, or faint. People using rotigotine have reported falling asleep without warning during activities of daily living, including driving, which sometimes resulted in accidents. This may happen as late as one year after taking the medicine. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think well. If these side effects are especially bothersome, check with your doctor.
This medicine may cause changes in your blood pressure or heart rate. Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, including confusion, delusions, feeling aggressive or hostile, or seeing, hearing, or feeling things that are not there (hallucinations). If you or your caregiver notice any of these side effects, tell your doctor right away.
Some people who have used this medicine had unusual changes in their thoughts or behavior, including an urge to gamble, spend money, binge eat, or an increased sex drive. Talk with your doctor if this is a concern for you.
This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, tingling of the hands or feet, or unusual weight gain or loss.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
The patch contains aluminum, which can cause skin burns when used during certain procedures such as magnetic resonance imaging (MRI) or cardioversion. To prevent skin burns, make sure the patch is removed before having these procedures.
Heat may cause too much of the rotigotine to pass through your skin. Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight. Direct sunlight may cause your skin to change color.
Tell your doctor if you develop a skin rash or irritation from the patch that lasts longer than a few days, becomes more severe, or spreads to areas outside the application site.
Do not change your dose or stop using this medicine suddenly without first asking your doctor. You will need to slowly decrease your dose before stopping it completely. Stopping this medicine suddenly may cause anxiety, confusion, depression, fever, lack of feeling or emotion, severe muscle stiffness, sweating, trouble sleeping, uncaring, or unusual tiredness or weakness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Burning, itching, redness, skin rash, swelling, or soreness at the application site
- swelling of the hands, ankles, feet, or lower legs
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision or other changes in vision
- difficult, burning, or painful urination
- dizziness
- frequent urge to urinate
- headache
- lower back or side pain
- nervousness
- pounding in the ears
- seeing, hearing, or feeling things that are not there
- slow or fast heartbeat
Incidence not known
- Anxiety
- dark-colored urine
- discouragement
- feeling sad or empty
- fever
- irritability
- lack of appetite
- lack of feeling or emotion
- loss of interest or pleasure
- muscle pain, stiffness, cramps, or spasms
- sweating
- tiredness
- trouble concentrating
- trouble sleeping
- uncaring
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- nausea
- seizures
- sweating
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Sleepiness or unusual drowsiness
Less common
- Acid or sour stomach
- belching
- difficulty having a bowel movement (stool)
- difficulty with moving
- dreaming abnormal
- dry mouth
- feeling of constant movement of self or surroundings
- heartburn
- indigestion
- loss of appetite
- muscle pain or stiffness
- pain in the joints
- sensation of spinning
- sleeplessness
- stomach discomfort, upset, or pain
- trouble sleeping
- unable to sleep
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20071097
