Stalevo is a combination medication that treats Parkinson's disease (PD) in adults. It contains carbidopa and levodopa, which help raise dopamine levels in the brain to improve PD symptoms. It also has entacapone, which works as a COMT inhibitor to help the effects last longer. Stalevo helps lessen "off" time (when movement symptoms come back as the medication wears off). Side effects include involuntary movements, nausea, and diarrhea.
Stalevo is a combination of three ingredients: carbidopa, levodopa, and entacapone. These ingredients work together to bring up the dopamine levels in the brain. This helps relieve symptoms of Parkinson's disease (PD).
| Common Brands | Stalevo |
|---|---|
| Drug Class | Dopa decarboxylase inhibitor / Dopamine replacement / COMT inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common-Entacapone
Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
Incidence not known-Carbidopa and Levodopa and/or Levodopa alone
Bleeding gums
bloody or black, tarry stools
bloody or cloudy urine
change in size, shape, or color of an existing mole
changes in skin color
chest pain, discomfort, or tightness
constricted pupil
convulsions
difficult or labored breathing
difficulty with speaking
drooping eyelid (ptosis)
facial dryness
fast, irregular, or pounding heartbeat
fever with or without chills
general feeling of illness
hallucinations (seeing, hearing, or feeling things that are not there)
hoarseness
large, flat, blue, or purplish patches in the skin
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
loss of bladder control
lower abdominal or stomach pain
lower back or side pain
mole that leaks fluid or bleeds
muscle cramps or spasms
muscle pain or stiffness
muscle trembling, jerking, or stiffness
painful or difficult urination
pinpoint red spots on the skin
raised red swellings on the skin, the buttocks, legs, or ankles
restlessness
severe mental changes
shakiness and unsteady walk
shuffling walk
sores, ulcers, or white spots on the lips or in the mouth
sweating
swollen glands
trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common-Entacapone
Acid or sour stomach
belching
bitter, sour, or unusual taste in the mouth
bloated
burning feeling in the chest or stomach
excess air or gas in the stomach or intestines
fear
full feeling
hyperventilation
increased sweating
indigestion
irritability
lack or loss of strength
passing gas
restlessness
sleepiness or unusual drowsiness
stomach discomfort or upset
swollen mouth and tongue
tenderness in the stomach area
trouble sleeping
urge to have bowel movement
Incidence not known-Carbidopa and Levodopa and/or Levodopa alone
Being forgetful
bladder pain
blurred vision
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning and upper abdominal or stomach pain
burning sensation of the tongue
clenching, gnashing, or grinding teeth
confusion about identity, place, and time
dark saliva
dark sweat
decreased mental acuity
difficulty swallowing
discouragement
double vision
ear congestion
enlarged pupils
excessive watering of the mouth
fainting
false or unusual sense of well-being
feeling like you will pass out
feeling of warmth
feeling sad or empty
flushing
headache
hiccups
hives or welts
increased blinking
increased interest in sexual ability, desire, drive, or performance
increased interest in sexual intercourse
lack of appetite
large, hard skin blisters
leg pain
loss of voice
muscle spasm, especially of the neck and back
nightmares
numbness
pain in the chest below the breastbone
painful or prolonged erection of the penis
pharyngeal pain
pounding in the ears
problems with memory or speech
redness of the face, neck, arms, and occasionally upper chest
sense of stimulation
skin rash
slow movement
slow or fast heartbeat
slow reflexes
swelling
tremor, increased
trouble concentrating
trouble recognizing objects
trouble thinking and planning
urinary frequency
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Stalevo can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Some people taking Stalevo have fallen asleep out of nowhere. This has happened even when they didn't feel tired beforehand. It can happen during activities like talking or eating. In some cases, people have fallen asleep while driving. It's sometimes led to accidents.
Avoid driving or doing things that need your full attention until you know how Stalevo affects you. This is especially important if you often feel sleepy or have suddenly fallen asleep before. Also avoid taking medications that make you sleepy while taking Stalevo. They can make you even sleepier.
Tell your prescriber know if you feel very sleepy during the daytime while taking Stalevo. Also let them know if you fall asleep during activities that you need to be alert for. Your prescriber can help decide if it's safe for you to keep taking the medication.
Some people who take Stalevo can have low blood pressure. It can cause a drop in blood pressure when you stand from a sitting or lying down position. Low blood pressure can lead to dizziness, lightheadedness, and sometimes fainting.
To lower your risk of falling, get up slowly when you stand. Tell your prescriber if your blood pressure is lower than usual or if you feel dizzy while taking Stalevo.
Stalevo can cause depression with or without suicidal behavior. Get medical help right away if you or the people around you notice that you have signs of depression or thoughts of hurting yourself while taking this medication.
Some people taking medications like Stalevo have had hallucinations. Others can also have feelings of uneasiness or distress. Tell your prescriber if you or your loved ones notice you're having hallucinations while you're taking Stalevo. Also let them know about any unusual behaviors or unusual thoughts.
Parkinson's medications that raise dopamine levels, like Stalevo, can cause impulsive behavior. These behaviors can include strong sexual urges and gambling urges. They can also be urges to spend a lot of money and binge eating. Urges can be hard to control.
Tell your prescriber if these behaviors negatively affect your life while taking Stalevo. You might not notice these urges. So, your prescriber might ask about them at your next visit.
Although rare, starting Stalevo, suddenly lowering the dose suddenly, or stopping it too fast can cause high fever and confusion. It can be life-threatening if these symptoms happen along with muscle stiffness, irregular pulse, rapid breathing, or changes in blood pressure.
Don't stop taking Stalevo or lower your dose without talking to your prescriber first. They can tell you how to do this safely.
The entacapone in Stalevo can cause people to have diarrhea. In studies, some had mild or moderate diarrhea. Rarely, people had severe diarrhea. People started to have diarrhea in the first few months of treatment. But it can sometimes start as early as the first week.
Keep in mind that diarrhea can be a sign of inflammation in the colon (colitis). Diarrhea in this case can be moderate or severe with watery, non-bloody stool. You might also have stomach pain.
Sometimes, diarrhea and colitis can lead to weight loss, dehydration, and low potassium levels. Be sure to drink lots of fluids to stay hydrated.
Tell your care team if you have any diarrhea or other related symptoms while taking Stalevo. Most of the time, diarrhea and colitis get better or go away after stopping the medication.
Some people who took Stalevo had severe muscle damage called rhabdomyolysis, which can be serious. Tell your prescriber right away if you have muscle aches, soreness, cramping, or a fever while you're taking Stalevo. These can be signs of serious muscle damage.
Taking medications with carbidopa and levodopa, like Stalevo, can lower your vitamin B6 levels. The risk of vitamin B6 deficiency is greater if you're taking a higher dose of the medication.
Low vitamin B6 can cause a rash, a swollen tongue, or numbness and tingling in your hands and feet. In serious cases, it can lead to depression, confusion, or even seizures. These seizures might not get better with usual anti-seizure medications. And they might only improve when given extra vitamin B6.
Your care team will check your vitamin levels with blood tests before you start Stalevo. They'll also check again periodically during treatment. Tell your care team if you notice symptoms of low vitamin B6. These include a sore tongue, cracked corners of your mouth, or numbness and tingling. Your care team might suggest a vitamin B6 supplement to keep your levels up.
Stalevo can interact with a few medications and cause side effects. Examples include apomorphine (Apokyn), methyldopa, and epinephrine (EpiPen). Taking Stalevo with these medications can raise your heart rate and blood pressure. It can cause changes to your heart rhythm.
It's also harmful to take Stalevo with nonselective monoamine oxidase inhibitors (MAOIs). Don't take Stalevo with nonselective MAOIs, like phenelzine (Nardil) and tranylcypromine (Parnate). Note that some Parkinson's medications like rasagiline (Azilect) and selegiline are selective MAO-B inhibitors. It's okay to take these Parkinson's medications with Stalevo.
Share a list of all your medications with your care team. They can check for interactions and make sure you're safe.
Let your prescriber know if you've had a stomach ulcer before. This is because Stalevo might raise your risk of stomach bleeding. Get medical help right away if you have severe stomach pain, vomit or cough up blood, or notice black stools that look like tar. These can be signs of stomach bleeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Stalevo will not be safe for you to take.
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No, don't crush the Stalevo tablets. You should swallow the table whole. Ask your prescriber about your options if you have trouble swallowing pills whole.
No, you shouldn't cut Stalevo tablets in half. The tablets don't have a score line (or an indented line down the middle) to help guide you to cut them evenly. It can be hard to cut an unscored tablet. You can also hurt yourself and also take the wrong dose. Swallow Stalevo tablets whole. If you have trouble swallowing pills whole, tell your prescriber. They can discuss other options with you.
It can be different for each person. But it typically takes Stalevo about 30 minutes to 1 hour to start working. It's important that you take Stalevo as prescribed so you can get the most relief from the medication. Talk to your prescriber if you have concerns about how fast Stalevo is working to help with your Parkinson's symptoms.
You'll usually need to take Stalevo a few times each day to help control your Parkinson's symptoms. Your prescriber will work with you to come up with a dosing schedule that works best for you. Follow their instructions carefully. And don't take your doses too close together or too far apart. Taking your doses at the same times each day can help keep the levels of medication stable in your body. This will help Stalevo work the best it can to relieve your Parkinson's symptoms.
Stalevo and Sinemet both help treat symptoms of Parkinson's disease. Stalevo contains carbidopa, levodopa, and entacapone. But Sinemet has carbidopa and levodopa only. The addition of entacapone in Stalevo helps levodopa reach and stay at higher levels in the brain. This can help lessen how much "off" time you have. This is when your symptoms come back as levodopa wears off in your body. Talk to your prescriber about other differences between the two medications.
Stalevo and Rytary both have carbidopa and levodopa to help with Parkinson's symptoms. But Stalevo also contains entacapone. Stalevo and Rytary work in different ways to help lessen "off" time. This is the time when your symptoms come back as the effects of levodopa wear off. Rytary is an extended-release capsule. It slowly releases medication into the body so it lasts longer. On the other hand, the entacapone in Stalevo helps the levodopa get into the brain better and stay at high levels longer. Talk to your prescriber to learn more about the differences between these medications.
