[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.
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as risperidone have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment. Tell your doctor and pharmacist if you are taking furosemide (Lasix).
Risperidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking risperidone. For more information visit the FDA website: http://www.fda.gov/Drugs
Risperidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat episodes of mania (frenzied, abnormally excited, or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in adults and in teenagers and children 10 years of age and older with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Risperidone is also used to treat behavior problems such as aggression, self-injury, and sudden mood changes in teenagers and children 5-16 years of age who have autism (a condition that causes repetitive behavior, difficulty interacting with others, and problems with communication). Risperidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Risperidone comes as a tablet, a solution (liquid), and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once or twice a day with or without food. Take risperidone 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 risperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Use the dropper provided to measure your dose of risperidone oral solution. You can take the oral solution with water, orange juice, coffee, or low-fat milk. Do not take the solution with tea or cola.
Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with or without liquid. Do not chew or crush the tablet.
Your doctor will probably start you on a low dose of risperidone and gradually increase your dose to allow your body to adjust to the medication.
Risperidone may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of risperidone. Continue to take risperidone even if you feel well. Do not stop taking risperidone without talking to your doctor. If you suddenly stop taking risperidone, your symptoms may return and your illness may become harder to treat.
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.
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. Do not take a double dose to make up for a missed one.
drowsiness
dizziness
nausea
vomiting
diarrhea
constipation
heartburn
dry mouth
increased saliva
increased appetite
weight gain
stomach pain
anxiety
agitation
restlessness
dreaming more than usual
difficulty falling asleep or staying asleep
decreased sexual interest or ability
breastmilk production
vision problems
muscle or joint pain
dry or discolored skin
difficulty urinating
fever
muscle stiffness
confusion
fast or irregular pulse
sweating
unusual movements of your face or body that you cannot control
faintness
seizures
slow movements or shuffling walk
rash
hives
itching
difficulty breathing or swallowing
painful erection of the penis that lasts for hours
Risperidone may cause children to gain more weight than expected and for boys and male adolescents to have an increase in the size of their breasts. Talk to your doctor about the risks of giving this medication to your child.
Risperidone may cause other side effects. Call your doctor if you have any unusual problems while 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 excess heat and moisture (not in the bathroom). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. 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.
drowsiness
fast, pounding, or irregular heartbeat
upset stomach
blurred vision
fainting
dizziness
seizures
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to risperidone.
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.