[Posted 06/13/2012] ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
Similarities of both the brand (proprietary) and generic (established) names
Similarities of the container labels and carton packaging
Illegible handwriting on prescriptions
Overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.
BACKGROUND: Risperidone (Risperdal) is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autistic disorder. Ropinirole (Requip) is a dopamine agonist used in the treatment of Parkinson's disease and Restless Legs Syndrome.
RECOMMENDATION: Healthcare Professionals are reminded to clearly print or spell out the medication name on prescriptions and make certain their patients know the name of their prescribed medication and their reason for taking it. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Ropinirole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Ropinirole is also used to treat Restless Legs Syndrome (RLS or Ekbom Syndrome; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Ropinirole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.
Ropinirole comes as a tablet and an extended-release (long-acting) tablet to take by mouth. Ropinirole may be taken with food to prevent stomach upset. When ropinirole is used to treat Parkinson's disease, the regular tablet is usually taken three times a day and the extended-release tablet is taken once daily. When ropinirole is used to treat Restless Legs Syndrome, the regular tablet is usually taken once a day, 1 to 3 hours before bedtime. Ropinirole extended-release tablets are not used to treat Restless Legs Syndrome. Take ropinirole at around the same time(s) every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take ropinirole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release tablets whole; do not split, chew, or crush them.
Your doctor will start you on a low dose of ropinirole and gradually increase your dose to help control your symptoms. If you are taking ropinirole to treat Parkinson's disease, your doctor will probably not increase your dose more often than once a week. If you are taking ropinirole to treat Restless Legs Syndrome, your doctor will probably increase your dose after 2 days, again at the end of the first week, and then not more often than once a week. It may take several weeks before you reach a dose that works for you. If you are taking ropinirole to treat Restless Legs Syndrome, you may receive a starter kit that contains tablets of increasing doses to be taken during the first 2 weeks of your treatment. The dose of medication you will need depends on how well your body responds to the medication, and may be different than the doses contained in the kit. Your doctor will tell you how to use the kit and whether you should take all the tablets it contains. Follow your doctor's directions carefully.
Ropinirole controls the symptoms of Parkinson's disease and Restless Legs Syndrome but does not cure these conditions. Continue to take ropinirole even if you feel well. Do not stop taking ropinirole without talking to your doctor. If you are taking ropinirole and you suddenly stop taking the medication, you may experience fever, fast heartbeat, muscle stiffness, sweating, confusion, and other symptoms. If your doctor asks you to stop taking ropinirole, your doctor will probably decrease your dose gradually, over 7 days.
If you stop taking ropinirole for any reason, do not start to take the medication again without talking to your doctor. Your doctor will probably want to increase your dose again gradually.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
If you are taking regular ropinirole tablets to treat Parkinson's disease and you miss a dose, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
If you are taking regular ropinirole tablets to treat Restless Legs Syndrome and you miss a dose, skip the missed dose. Take your regular dose 1 to 3 hours before your next bedtime. Do not double the next dose to make up for the missed dose.
If you are taking extended-release ropinirole tablets to treat Parkinson's disease and you miss a dose, take the missed dose as soon as you remember it. Return to your regular dosing schedule the next day. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
nausea
vomiting
stomach pain
heartburn or gas
diarrhea
constipation
decrease in appetite
weight loss
dizziness
drowsiness
tiredness
weakness
headache
sweating or flushing
confusion
difficulty remembering or concentrating
anxiety
uncontrolled, sudden body movements
shaking of a part of your body that you cannot control
decreased sensitivity (response) to touch
frequent or urgent need to urinate
difficulty urinating or pain when urinating
in men, difficulty achieving or maintaining an erection
back, muscle, or joint pain
pain, burning, numbness, or tingling in the hands or feet
swelling of the hands, arms, feet, ankles, or lower legs
dry mouth
hallucinations (seeing things or hearing voices that do not exist)
fainting
chest pain
slow, fast, or irregular heartbeat
shortness of breath
difficulty swallowing
double vision or other changes in vision
People who have Parkinson's disease may have a greater risk of developing melanoma (a type of skin cancer) than people who do not have Parkinson's disease. There is not enough information to tell whether medications used to treat Parkinson's disease such as ropinirole increase the risk of developing skin cancer. You should have regular skin examinations to check for melanoma while you are taking ropinirole even if you do not have Parkinson's disease. Talk to your doctor about the risk of taking ropinirole.
Some people taking ropinirole and other similar medications have developed fibrotic changes (scarring or thickening) in their lungs and heart valves. It is not yet known whether this problem is caused by ropinirole. Talk to your doctor about the risk of taking this medication.
Ropinirole may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from direct sunlight, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
nausea
vomiting
dizziness
fainting
hallucinations (seeing things or hearing voices that do not exist)
nightmares
drowsiness
confusion
sweating
fear when in a small or closed space
body movements that are difficult to control
fast, irregular, or pounding heartbeat
chest pain
weakness
cough
agitation
Keep all appointments with your doctor.
Do not let anyone else take your medication.Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 04/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.