Levodopa and Carbidopa
(lee voe doe' pa) (kar bi doe' pa)
- Atamet®(as a combination product containing Carbidopa, Levodopa)
- Parcopa®(as a combination product containing Carbidopa, Levodopa)
- Sinemet®(as a combination product containing Carbidopa, Levodopa)
- Stalevo®(as a combination product containing Carbidopa, Entacapone, Levodopa)
[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: Web Siteand Web Site.
[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: Web Siteand Web Site.
WHY is this medicine prescribed?
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.
HOW should this medicine be used?
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.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking levodopa and carbidopa,
- tell your doctor and pharmacist if you are allergic to levodopa and carbidopa any other medications, or any of the ingredients in levodopa and carbidopa tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking phenelzine (Nardil) or tranylcypromine (Parnate) or if you have stopped taking them in the past 2 weeks. Your doctor will probably tell you not to take levodopa and carbidopa.
- 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') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; haloperidol (Haldol); ipratropium (Atrovent); iron pills and vitamins containing iron; isocarboxazid (Marplan); isoniazid (INH, Nydrazid); medications for high blood pressure, irritable bowel disease, mental illness, motion sickness, nausea, ulcers, or urinary problems; metoclopramide (Reglan); papaverine (Pavabid); phenytoin (Dilantin); rasagiline (Azilect); risperidone (Risperdal); and selegiline (Eldepryl). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had glaucoma, melanoma (skin cancer), or a skin growth that has not been diagnosed. Your doctor may tell you not to take levodopa and carbidopa.
- tell your doctor if you have or have ever had hormone problems; asthma; emphysema; mental illness; diabetes; ulcers; heart attacks; irregular heartbeat; or blood vessel, heart, kidney, liver or lung disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking levodopa and carbidopa, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking levodopa and carbidopa.
- you should know that while taking levodopa and carbidopa, your saliva, urine, or sweat may become a dark color (red, brown, or black). This is harmless, but your clothing may become stained.
- if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain aspartame that forms phenylalanine.
What SPECIAL DIETARY instructions should I follow?
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.
What should I do IF I FORGET to take 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. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Levodopa and carbidopa may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- loss of appetite
- dry mouth
- change in sense of taste
- forgetfulness or confusion
- difficulty falling asleep or staying asleep
- increased sweating
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- unusual or uncontrolled movements of the mouth, tongue, face, head, neck, arms, and legs
- fast, irregular, or pounding heartbeat
- 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
- difficulty swallowing or breathing
- black and tarry stools
- red blood in stools
- bloody vomit
- vomit that looks like coffee grounds
What should I know about STORAGE and DISPOSAL of this medication?
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.
What should I do in case of OVERDOSE?
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.
What OTHER INFORMATION should I know?
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.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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