[Posted 08/20/2010] Issue: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). FDA's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation - Parkinson's Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death.
Background: Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own). It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.
Recommendations: At this time, FDA's review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional.
FDA is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when this review is complete. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
[Posted 03/31/2010] FDA notified healthcare professionals and patients that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo (entacapone, levodopa, and carbidopa combination) may be at an increased risk for developing prostate cancer. Other controlled clinical trials evaluating Stalevo or entacapone (Comtan) did not find an increased risk of prostate cancer. FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer. Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing Stalevo and entacapone. Patients should not stop taking their medication unless directed to do so by their healthcare professional. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
The combination of levodopa and carbidopa is used to treat the symptoms of Parkinson's disease and Parkinson's-like symptoms that may develop after encephalitis (swelling of the brain) or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning. Parkinson's symptoms, including tremors (shaking), stiffness, and slowness of movement, are caused by a lack of dopamine, a natural substance usually found in the brain. Levodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain. Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preventing levodopa from being broken down before it reaches the brain. This allows for a lower dose of levodopa, which causes less nausea and vomiting.
The combination of levodopa and carbidopa comes as a regular tablet, an orally disintegrating tablet, and an extended-release (long-acting) tablet to take by mouth. The regular and orally disintegrating tablets are usually taken three or four times a day. The extended-release tablet is usually taken two to four times a day. Take levodopa and carbidopa at around the same times 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 levodopa and carbidopa 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.
To take the orally disintegrating tablet, remove the tablet from the bottle using dry hands and immediately place it in your mouth. The tablet will quickly dissolve and can be swallowed with saliva. No water is needed to swallow disintegrating tablets.
If you are switching from levodopa (Dopar or Larodopa; no longer available in the US) to the combination of levodopa and carbidopa, follow your doctor's instructions. You will probably be told to wait at least 12 hours after your last dose of levodopa to take your first dose of levodopa and carbidopa.
Your doctor may start you on a low dose of levodopa and carbidopa and gradually increase your dose of the regular or orally disintegrating tablet every day or every other day as needed. The dose of the extended-release tablet may be gradually increased after 3 days as needed.
Levodopa and carbidopa controls Parkinson's disease but does not cure it. It may take several months before you feel the full benefit of levodopa and carbidopa. Continue to take levodopa and carbidopa even if you feel well. Do not stop taking levodopa and carbidopa without talking to your doctor. If you suddenly stop taking levodopa and carbidopa, you could develop a serious syndrome that causes fever, rigid muscles, unusual body movements, and confusion. Your doctor will probably decrease your dose gradually.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Talk to your doctor if you plan on changing your diet to foods that are high in protein, such as meat, poultry, and dairy products.
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.
dizziness
nausea
vomiting
loss of appetite
diarrhea
dry mouth
constipation
change in sense of taste
forgetfulness or confusion
nervousness
nightmares
difficulty falling asleep or staying asleep
headaches
weakness
increased sweating
drowsiness
unusual or uncontrolled movements of the mouth, tongue, face, head, neck, arms, and legs
fast, irregular, or pounding heartbeat
depression
thoughts of death or killing oneself
hallucinating (seeing things or hearing voices that do not exist)
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
difficulty swallowing or breathing
hives
black and tarry stools
red blood in stools
bloody vomit
vomit that looks like coffee grounds
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). 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.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to levodopa and carbidopa.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking levodopa and carbidopa.
Levodopa and carbidopa can lose its effect completely over time or only at certain times during the day. Call your doctor if your Parkinson's disease symptoms (shaking, stiffness, and slowness of movement) worsen or vary in severity.
As your condition improves and it is easier for you to move, be careful not to overdo physical activities. Increase your activity gradually to avoid falls and injuries.
Levodopa and carbidopa can cause false results in urine tests for sugar (Clinistix, Clinitest, and TesTape) and ketones (Acetest, Ketostix, and Labstix). Diabetic patients should use TesTape to test urine for glucose (sugar); better results can be obtained by holding the tape vertically, inserting the lower portion of the tape into the urine sample, and reading the color at the top of the damp area.
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 - 09/01/2010
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.