[Posted 06/13/2011]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.
The FDA determined that the factors contributing to the confusion between the two products include:
- 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: Web Siteand Web Site.
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.
Before taking ropinirole,
- tell your doctor and pharmacist if you are allergic to ropinirole, any other medications, or any of the ingredients in ropinirole tablets or extended-release tablets. Ask your doctor or pharmacist for a list of ingredients in ropinirole regular or extended-release tablets.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants ('mood elevators'); antipsychotics (medications for mental illness); cimetidine (Tagamet, Tagamet HB); fluoroquinolone antibiotics such as ciprofloxacin (Cipro), and norfloxacin (Noroxin); fluvoxamine (Luvox); hormone replacement therapy and hormonal contraceptives (birth control pill, patches, rings, and injections); insulin; lansoprazole (Prevacid); levodopa (in Sinemet, in Stalevo); medications for anxiety and seizures; medications that cause drowsiness; metoclopramide (Reglan); mexiletine (Mexitil); modafanil (Provigil); nafcillin; omeprazole (Prilosec, Zegerid); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Be sure to tell your doctor or pharmacist if you stop taking any medications while you are taking ropinirole.
- tell your doctor if you have ever had an urge to gamble that was difficult to control and if you have or have ever had unexpected daytime sleepiness or a sleep disorder other than restless legs syndrome; high or low blood pressure; a psychotic disorder (mental illness that causes abnormal thinking or perceptions); or heart, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ropinirole, call your doctor.
- you should know that ropinirole may make you drowsy or may cause you to suddenly fall asleep during your regular daily activities. You might not feel drowsy or have any other warning signs before you suddenly fall asleep. Do not drive a car,operate machinery, work at heights, or participate in potentially dangerous activities at the beginning of your treatment until you know how the medication affects you. If you suddenly fall asleep while you are doing something such as watching television, talking, eating, or riding in a car, or if you become very drowsy, especially during the daytime, call your doctor. Do not drive, work in high places, or operate machinery until you talk to your doctor.
- remember that alcohol can add to the drowsiness caused by this medication. Tell your doctor if you regularly drink alcoholic drinks.
- tell your doctor if you use tobacco products. Call your doctor if you start or stop smoking during your treatment with ropinirole. Smoking may decrease the effectiveness of this medication.
- you should know that some people who took medications such as ropinirole developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.
- you should know that ropinirole may cause dizziness, lightheadedness, nausea, or sweating when you get up too quickly from a sitting or lying position. This is more common when you first start taking ropinirole or with an increase in the dose of ropinirole. To avoid this problem, get out of the chair or bed slowly, resting your feet on the floor for a few minutes before standing up.
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.
Ropinirole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- heartburn or gas
- decrease in appetite
- weight loss
- sweating or flushing
- difficulty remembering or concentrating
- 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
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- hallucinations (seeing things or hearing voices that do not exist)
- 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 Web Site] 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.
Symptoms of overdose may include:
- hallucinations (seeing things or hearing voices that do not exist)
- fear when in a small or closed space
- body movements that are difficult to control
- fast, irregular, or pounding heartbeat
- chest pain
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.
AHFS® Consumer Medication Information. © Copyright, 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.
Selected Revisions: June 15, 2011.