Rotigotine (Transdermal route)
- Patch, Extended Release
Uses of This Medicine:
Rotigotine transdermal patch is used to treat symptoms of Parkinson's disease, sometimes called shaking palsy. It is a dopamine agonist that helps improve muscle control and reduce muscle stiffness to allow more normal movements of the body.
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. 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.
Before Using This Medicine:
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rotigotine transdermal patch in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Asthma or
- Congestive heart failure or
- Dyskinesia (abnormal muscle movements) or
- Edema (fluid in the hands, lower legs, or feet) or
- Heart or blood vessel disease or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Kidney disease, severe or
- Lung disease or
- Melanoma (skin cancer), history of or
- Mental illness (e.g., psychosis)—Use with caution. May make these conditions worse.
- Sleep disorders—May worsen sleepiness or episodes of falling asleep during an activity.
- Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite.
Proper Use of This Medicine:
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 20 to 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.
- 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.
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:
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.
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 While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
This medicine may cause some people to become dizzy, drowsy, sleepiness, or trouble with thinking. 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.
Dizziness, lightheadedness, or fainting may occur with this medicine, 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, such as 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 behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.
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.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are using this medicine.
It is important that your doctor check your skin for melanoma (cancer) regularly while you are using this medicine.
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.
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, tell your doctor. Also, do not expose the area to direct sunlight until it heals. Direct sunlight may cause your skin to change color.
Do not stop using this medicine suddenly without first asking your doctor. You will need to slowly decrease your dose before stopping it completely.
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 of This Medicine:
- 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
- frequent urge to urinate
- lower back or side pain
- pounding in the ears
- seeing, hearing, or feeling things that are not there
- slow or fast heartbeat
- Symptoms of overdose
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- unusual tiredness or weakness
- More common
- Sleepiness or unusual drowsiness
- Less common
- Acid or sour stomach
- difficulty having a bowel movement (stool)
- difficulty with moving
- dreaming abnormal
- dry mouth
- feeling of constant movement of self or surroundings
- loss of appetite
- muscle pain or stiffness
- pain in the joints
- sensation of spinning
- stomach discomfort, upset, or pain
- trouble sleeping
- unable to sleep
- weight loss
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 11/4/2014