Stalevo (carbidopa/levodopa/ entacapone)

What is Stalevo?

Stalevo is a brand-name prescription drug. It’s FDA-approved to treat Parkinson’s disease (PD) in adults.

Stalevo is used to treat PD in adults who are:

• Switching from a two-tablet regimen to a single tablet. Stalevo may be used in people who want to switch from taking a two-pill regimen (carbidopa/levodopa tablets with separate entacapone tablets) to a single pill with the same active drugs and strengths.
• Taking 600 milligrams (mg) or less of levodopa per day and haven’t experienced dyskinesia* but have had “off periods” of PD. An off period occurs when a drug’s effects begin to wear off and your PD symptoms return. For this use, Stalevo replaces carbidopa/levodopa treatment (without entacapone).

Stalevo is approved for these uses in certain situations. To learn more about the drug’s uses, see the “Stalevo for Parkinson’s disease” section below.

* With dyskinesia, you have uncontrolled and sudden body movements.

Drug details

Stalevo comes as tablets that are taken by mouth. Stalevo works to reduce symptoms of PD by increasing levels of the brain chemical dopamine.

It comes as a single tablet that contains three drugs: levodopa, carbidopa, and entacapone. The tablets are available in six strengths:

• Stalevo 50: 12.5 mg of carbidopa/50 mg of levodopa/200 mg of entacapone
• Stalevo 75: 18.75 mg of carbidopa/75 mg of levodopa/200 mg of entacapone
• Stalevo 100: 25 mg of carbidopa/100 mg of levodopa/200 mg of entacapone
• Stalevo 125: 31.25 mg of carbidopa/125 mg of levodopa/200 mg of entacapone
• Stalevo 150: 37.5 mg of carbidopa/150 mg of levodopa/200 mg of entacapone
• Stalevo 200: 50 mg of carbidopa/200 mg of levodopa/200 mg of entacapone

Effectiveness

For information about the effectiveness of Stalevo, see the “Stalevo for Parkinson’s disease” section below.

Stalevo generic

Stalevo is a brand-name drug that contains the active drugs levodopa, carbidopa, and entacapone. This combination of active drugs is also available as a generic medication. A generic drug is an exact copy of the active drug in a brand-name medication.

The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using the generic form of Stalevo, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition.

Stalevo dosage

The Stalevo dosage your doctor prescribes will depend on several factors. These include:

• the severity of the condition you’re using Stalevo to treat
• the side effects you experience from your Parkinson’s disease (PD) treatment
• other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths: Stalevo 50 to Stalevo 200

Stalevo comes as tablets that are taken by mouth. The tablets are available in six strengths:

• Stalevo 50: 12.5 mg of carbidopa/50 mg of levodopa/200 mg of entacapone
• Stalevo 75: 18.75 mg of carbidopa/75 mg of levodopa/200 mg of entacapone
• Stalevo 100: 25 mg of carbidopa/100 mg of levodopa/200 mg of entacapone
• Stalevo 125: 31.25 mg of carbidopa/125 mg of levodopa/200 mg of entacapone
• Stalevo 150: 37.5 mg of carbidopa/150 mg of levodopa/200 mg of entacapone
• Stalevo 200: 50 mg of carbidopa/200 mg of levodopa/200 mg of entacapone

Dosage for Parkinson’s disease

Stalevo is approved for use in people with Parkinson’s disease (PD). Stalevo dosages vary, depending on several factors. Your doctor will determine the dosage that’s best for you. Typically, you’ll take the lowest dosage possible that improves your symptoms.

Dosage questions

Below are answers to some questions you may have about taking Stalevo.

What if I miss a dose?

You should try to take your Stalevo doses at the same time each day. This helps you maintain the right levels of dopamine in your body. If you miss a dose, take it as soon as you remember. However, if it’s almost time for your next dose, just skip the missed dose. Then take your next dose at its regular time.

You shouldn’t take two doses at once to make up for a missed dose. This could raise your risk for side effects from the drug. If you’ve missed a dose and are unsure of when to take your next dose, call your doctor’s office.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Stalevo is meant to be used as a long-term treatment. If you and your doctor determine that Stalevo is safe and effective for you, you’ll likely take it long term.

Stalevo side effects

Stalevo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Stalevo. These lists do not include all possible side effects.

For more information about the possible side effects of Stalevo, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Stalevo, you can do so through MedWatch.

Mild side effects

Mild side effects* of Stalevo can include:

• diarrhea†
• nausea and vomiting†
• abdominal (belly) pain
• dry mouth
• dark urine that may be red, brown, or black

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Stalevo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Stalevo’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Stalevo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Sleepiness or falling asleep during daily activities.*
• Dyskinesia (uncontrolled and sudden body movements). *
• Trouble controlling impulses.*
• Severe diarrhea.*
• Psychosis (loss of touch with reality) and hallucinations (seeing or hearing something that’s not really there).*
• Depression or suicidal thoughts or behaviors.*
• Hypotension (low blood pressure). This may get worse when you stand up too quickly from a seated position. Symptoms can include:
  • fainting
  • dizziness
  • feeling more tired than usual
• Rhabdomyolysis (breakdown of your muscles). This condition can lead to kidney damage. Symptoms can include:
  • muscle swelling
  • sore, achy, or throbbing muscles
  • dark or tea-colored urine
  • fatigue (lack of energy)
• Fever and confusion (if suddenly stopping Stalevo). Symptoms can include:
  • fever of more than 106.7°
  • confusion and trouble thinking clearly

* For more information about this side effect, see “Side effect details” below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Side effects with dosage increases

Typically, your doctor will start you on a low dosage of Stalevo and carefully monitor how you respond. Your doctor may adjust your dosage depending on how well the drug is working to treat your Parkinson’s symptoms.

Your doctor may also adjust your dosage if you start to have side effects. Side effects may occur at any dose of Stalevo. To lower your risk for side effects, your doctor will start you on a low dose and slowly increase your dosage over time.

If you have questions about how your Stalevo dosage may be adjusted during your treatment, talk with your doctor.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Stalevo. It’s not known how often allergic reaction may have occurred in clinical studies of Stalevo.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth, swelling, or redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Stalevo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Sleepiness

Stalevo may cause sleepiness. In clinical studies:

• 2% of people taking carbidopa/levodopa/entacapone (Stalevo) experienced sleepiness
• 0% of people taking carbidopa/levodopa plus a placebo (a treatment with no active drug) experienced sleepiness

Symptoms of sleepiness can include feeling drowsy at any time of day, drowsiness while driving, and falling asleep during daily activities such as talking or driving.

If you experience sleepiness while taking Stalevo, talk with your doctor. They may suggest ways to help reduce this side effect.

Uncontrolled movements or restlessness

It’s possible to have dyskinesia (uncontrolled or sudden body movements) while taking Stalevo. In clinical studies, these side effects occurred in:

• 25% of people taking carbidopa/levodopa/entacapone (Stalevo)
• 15% of people taking carbidopa/levodopa plus a placebo

Symptoms of dyskinesia can include tremor (movement you can’t control), head bobbing, and fidgeting.

If you experience uncontrolled movements while taking Stalevo, talk with your doctor. They may suggest ways to help relieve this side effect. They may also need to adjust your medication to a lower dose if the movements become too bothersome.

Trouble controlling impulses

Impulsive behaviors have been reported in some people taking Stalevo. However, it’s not known how often this may have occurred in people taking Stalevo in clinical trials. In most cases, impulsive behaviors may stop once someone’s Stalevo dosage is lowered or they end their treatment.

Examples of these impulses include making large purchases that you wouldn’t usually make, a new or increased desire to gamble, and increased sexual urges.

If you’re concerned about impulsive behaviors during Stalevo treatment, talk with your doctor. If impulsive behaviors occur, your doctor may need to adjust your dosage, or you may need to stop Stalevo treatment.

Diarrhea

Some people experience diarrhea while taking Stalevo. In clinical studies, diarrhea occurred in:

• 10% of people taking carbidopa/levodopa/entacapone (Stalevo)
• 4% of people taking carbidopa/levodopa plus a placebo (a treatment with no active drug)

Symptoms of diarrhea can include watery stools, dehydration, fatigue, and pain and cramping in the lower belly.

In some cases, diarrhea can last for several days and be a symptom of a more serious problem called colitis. With this condition, you have inflammation (swelling and damage) in your colon. Symptoms of colitis may include lower belly pain, unexplained weight loss, and dehydration.

If you’re concerned about diarrhea while taking Stalevo, talk with your doctor. And call your doctor right away if you have diarrhea that last more than a few days, as you may have colitis.

Nausea or vomiting

Some people may experience nausea and vomiting while taking Stalevo. In clinical studies:

• 14% of people taking carbidopa/levodopa/entacapone (Stalevo) experienced nausea
• 8% of people taking carbidopa/levodopa plus a placebo (a treatment with no active drug) experienced nausea

In addition, in clinical studies:

• 4% of people taking carbidopa/levodopa/entacapone (Stalevo) reported vomiting
• 1% of people taking carbidopa/levodopa plus a placebo reported vomiting

Hallucinations

Drugs such as Stalevo that raise dopamine levels in the body have been known to cause hallucinations in some people. (With hallucinations, you see or hear things that aren’t really there.)

In clinical studies:

• 0.8% of people taking carbidopa/levodopa/entacapone (Stalevo) stopped treatment because of hallucinations. 1% of people taking Stalevo were hospitalized due to hallucinations.
• 0% of people taking carbidopa/levodopa plus a placebo stopped treatment because of hallucinations. 0.3% of people taking carbidopa/levodopa plus a placebo were hospitalized due to hallucinations.

Symptoms of hallucinations may include:

• confusion
• insomnia (trouble falling asleep or staying asleep)
• dreaming much more than usual
• feeling out of touch with reality

If you experience hallucinations while taking Stalevo, talk with your doctor right away. They may need to adjust your dosage or stop your Stalevo treatment.

Depression or suicidal thoughts or behaviors

Depression or suicidal thoughts have been reported in some people taking Stalevo. However, it’s not known how often this may have occurred in clinical trials.

Symptoms of these side effects can include:

• changes in your appetite
• sleeping more than usual
• having little interest in activities that you used to enjoy
• feeling hopeless

Alternatives to Stalevo

Other drugs are available that can treat Parkinson’s disease (PD). Some may be a better fit for you than others. If you’re interested in finding an alternative to Stalevo, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Examples of other drugs that may be used alone or with other drugs to treat PD include:

• carbidopa/levodopa (Sinemet)
• extended-release carbidopa/levodopa (Rytary)
• selegiline hydrochloride (Zelapar)
• entacapone (Comtan)
• tolcapone (Tasmar)
• safinamide (Xadago)
• rasagiline (Azilect)

Stalevo vs. Sinemet

You may wonder how Stalevo compares with other medications that are prescribed for similar uses. Here we look at how Stalevo and Sinemet are alike and different.

Ingredients

Stalevo and Sinemet both contain the active drugs carbidopa and levodopa. In addition, Stalevo contains a third drug called entacapone.

These active drugs belong to different drug classes, and each one works differently to help increase the level of dopamine in your body. (A drug class is a group of medications that work in a similar way.) Specifically, carbidopa is a decarboxylation inhibitor, levodopa is a dopamine precursor, and entacapone is a catechol-O-methyltransferase (COMT) inhibitor.

Uses

Here’s a list of conditions that the Food and Drug Administration (FDA) has approved Stalevo and Sinemet to treat.

• Both Stalevo and Sinemet are FDA-approved to treat:
  • Parkinson’s disease (PD)
• Sinemet is also FDA-approved to treat:
  • certain kinds of Parkinsonism

Drug forms and administration

Stalevo and Sinemet both come as tablets that are taken by mouth.

Side effects and risks

Stalevo and Sinemet both contain carbidopa and levodopa. Therefore, these medications can cause very similar side effects but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, as well as mild side effects that both drugs may share.

• Can occur with Stalevo:
  • dark urine that may be red, brown, or black
• Can occur with Sinemet:
  • upper respiratory infection, such as the common cold
• Can occur with both Stalevo and Sinemet:
  • diarrhea
  • nausea and vomiting
  • abdominal (belly) pain
  • dry mouth

Serious side effects

These lists contain examples of serious side effects that can occur with Stalevo or Sinemet, as well as serious side effects that both drugs may share.

• Can occur with Stalevo:
  • severe diarrhea that lasts longer than a few days and may lead to colitis
  • rhabdomyolysis (breakdown of your muscles)
  • fever of over 106.7° and confusion (if suddenly stopping Stalevo)
  • low potassium levels
• Can occur with Sinemet
  • urinary tract infection (UTI)
  • abnormal blood counts, including low white and red blood cell counts
• Can occur with both Stalevo and Sinemet:
  • sleepiness or falling asleep during daily activities
  • dyskinesia (uncontrolled and sudden body movements)
  • allergic reaction
  • depression and suicidal thoughts or behaviors
  • trouble controlling impulses
  • hypotension, which may be worse when standing up after sitting
  • psychosis and hallucinations

Effectiveness

The use of Stalevo and Sinemet in treating PD has been directly compared in two clinical studies. The studies showed that Stalevo and Sinemet are similarly effective in treating PD.

In both studies, adults took either carbidopa/levodopa/entacapone (Stalevo) or levodopa/carbidopa (the active ingredients in Sinemet) plus a placebo for 24 weeks. (A placebo is a treatment with no active drug.)

The studies looked at “on periods” and “off periods” of PD. An on period is when you have few or no symptoms of PD. An off period occurs when a drug’s effects begin to wear off, and your PD symptoms return.

In the first study, the average length of an on period while awake increased by:

• 1.5 hours for those taking Stalevo. This means that for every 18 hours awake, people taking Stalevo had their on periods increased by 1.5 hours compared with when they started the study.
• 0.1 hours for those taking levodopa/carbidopa plus a placebo. This means that for every 18 hours awake, people using this treatment had their on periods increased by 0.1 hours compared with when they started the study.

In a second study, the average length of an on period while awake per 24 hours increased by:

• 6.7% for those taking Stalevo
• 2.0% for those taking levodopa/carbidopa plus a placebo

For more clinical study results, see the Stalevo’s prescribing information.

Costs

Sinemet generally costs less than Stalevo. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Stalevo and Sinemet are both brand-name drugs. Both drugs also have a generic form. Brand-name medications usually cost more than generics.

Stalevo for Parkinson’s disease

The Food and Drug Administration (FDA) approves prescription drugs such as Stalevo to treat certain conditions. Stalevo may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Stalevo is FDA-approved to treat Parkinson’s disease (PD) in adults who are:

• Switching from a two-tablet regimen to a single tablet. Stalevo may be used in people who want to switch from taking a two-pill regimen (carbidopa/levodopa tablets with separate entacapone tablets) to a single pill with the same active drugs. When switching to Stalevo, you’ll take the same strength of the three active drugs that you were taking in your two-pill regimen.
• Taking 600 milligrams (mg) or less of levodopa per day and haven’t experienced dyskinesia* but have had “off periods” of PD. An off period occurs when a drug’s effects begin to wear off and your PD symptoms return. For this use, Stalevo replaces carbidopa/levodopa treatment (without entacapone).

Stalevo works by increasing dopamine levels in the brain. This helps to relieve symptoms of PD.

* With dyskinesia, you have uncontrolled and sudden body movements.

About PD

PD is a movement disorder that affects your nervous system and causes symptoms that get worse over time. In people with PD, the brain cells that make dopamine* begin to die or stop working as well. This causes low levels of dopamine in the brain.

Over time, this loss of dopamine affects your control over your body movements. When this happens, the most common symptoms of Parkinson’s disease usually start to appear.

Symptoms of PD may include:

• dyskinesia (uncontrolled or sudden body movements)
• loss of balance
• stiff or rigid muscles
• fidgeting

* Dopamine is a brain chemical that sends messages to your body to help control your movements.

Effectiveness for PD

In clinical studies of adults with PD, Stalevo was shown to be an effective treatment.

In two studies, adults took either carbidopa/levodopa/entacapone (Stalevo) or levodopa/carbidopa (the active ingredients in Sinemet) plus a placebo for 24 weeks. (A placebo is a treatment with no active drug.)

The studies looked at “on periods” and “off periods” of PD. An on period is when you have few or no symptoms of PD. An off period occurs when a drug’s effects begin to wear off and your PD symptoms return.

In the first study, the average length of an on period while awake increased by:

• 1.5 hours for those taking Stalevo. This means that for every 18 hours awake, people taking Stalevo had their on periods increased by 1.5 hours compared with when they started the study.
• 0.1 hours for those taking levodopa/carbidopa plus a placebo. This means that for every 18 hours awake, people using this treatment had their on periods increased by 0.1 hours compared with when they started the study.

In a second study, the average length of an on period per 24 hours increased by:

• 6.7% for those taking Stalevo
• 2.0% for those taking levodopa/carbidopa plus a placebo

For more clinical study results, see Stalevo’s prescribing information.

Stalevo and children

Stalevo isn’t approved for use in children. This drug has only been studied in adults. Therefore, it’s not known whether Stalevo is safe or effective when used in children.

Stalevo use with other drugs

In some cases, your doctor may prescribe other drugs for you to take with Stalevo. Additional drugs may help with motor symptoms of Parkinson’s disease (PD) such as muscle rigidity, shaking, and dyskinesia (uncontrolled or sudden body movements).

Your doctor may also prescribe add-on drugs to help with symptoms such as depression, dementia, and hallucinations (seeing or hearing something that’s not really there).

Some examples of drugs that may be used with Stalevo include:

• selegiline (Zelapar)
• amantadine (Symmetrel)
• istradefylline (Nourianz)
• safinamide (Xadago)
• inhaled levodopa (Inbrija)

Talk with your doctor to determine if you should take other medications with Stalevo.

How Stalevo works

Stalevo is FDA-approved to treat Parkinson’s disease (PD) in adults who are:

• Switching from a two-tablet regimen to a single tablet. Stalevo may be used in people who want to switch from taking a two-pill regimen (carbidopa/levodopa tablets with separate entacapone tablets) to a single pill with the same active drugs.
• Taking 600 milligrams (mg) or less of levodopa per day and haven’t experienced dyskinesia* but have had “off periods” of PD. An off period occurs when a drug’s effects begin to wear off and your PD symptoms return. For this use, Stalevo replaces carbidopa/levodopa treatment (without entacapone).

* With dyskinesia, you have uncontrolled and sudden body movements.

What happens with PD

PD is a movement disorder that affects your nervous system and causes symptoms that get worse over time. In people with PD, the brain cells that make dopamine* begin to die or stop working as well. This causes low levels of dopamine in the brain.

Over time, this loss of dopamine affects your control over your body movements. When this happens, the most common symptoms of Parkinson’s disease usually start to appear. These symptoms may include:

• dyskinesia (uncontrolled or sudden body movements)
• loss of balance
• stiff or rigid muscles
• fidgeting

* Dopamine is a brain chemical that sends messages to your body to help control your movements.

What Stalevo does

Stalevo contains three active drugs: levodopa, carbidopa, and entacapone. These drugs work together to increase dopamine levels in your brain. This helps relieve the symptoms of Parkinson’s disease (PD) and allows you to better control your movements.

How long does it take to work?

Stalevo starts working right away in your body. Stalevo tablets are immediate-release (IR), which means that the drug is released into your body all at once. Within an hour or less after taking your dose, you may start to notice that your symptoms of PD have improved.

Stalevo overdose

Using more than the recommended dosage of Stalevo can lead to serious side effects.

Do not use more Stalevo than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

• low blood pressure
• fast heart rate
• severe psychiatric problems, such as hallucinations (seeing or hearing something that’s not really there)
• rhabdomyolysis (breakdown of your muscles)

What to do in case you take too much Stalevo

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Stalevo withdrawal and dependence

There haven’t been studies done on whether Stalevo can cause drug dependence.

You should not suddenly stop taking Stalevo. Doing so could cause serious side effects. This could include a rare but life threatening group of symptoms that’s similar to neuroleptic malignant syndrome. These symptoms can include:

• fever
• confusion
• high or low blood pressure
• stiff or rigid muscles
• changes in consciousness

If you need to stop taking Stalevo, talk with your doctor. They’ll recommend a treatment plan to help you safely stop taking this drug. Typically, your doctor will gradually reduce your dosage over a period of time until it’s safe for you to completely stop treatment.

Stalevo and alcohol

Stalevo is not known to interact with alcohol. However, both Stalevo and alcohol can cause:

• low blood pressure
• trouble thinking
• dizziness
• sleepiness

Drinking alcohol while you’re taking Stalevo may raise your risk for these side effects. These side effects can become serious.

If you drink alcohol, talk with your doctor about drinking while you’re taking Stalevo. Your doctor may be able to recommend a safe amount for you to drink. Or they may recommend that you avoid alcohol during your treatment.

Stalevo interactions

Stalevo can interact with several other medications. It can also interact with certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Stalevo and other medications

Below is a list of medications that can interact with Stalevo. This list does not contain all drugs that may interact with Stalevo.

Before taking Stalevo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Stalevo and nonselective MAO inhibitors

People taking Stalevo should not use nonselective monoamine oxidase inhibitors (MAOIs). MAOIs are used to treat depression.

The use of Stalevo with an MAOI is a contraindication. A contraindication is a specific situation in which a drug should not be used because it may cause you harm.

Tell your doctor if you’re taking a nonselective MAOI. Your doctor will likely have you stop taking your MAOI at least 2 weeks before starting Stalevo.

Examples of nonselective MAOIs include:

• phenelzine (Nardil)
• tranylcypromine (Parnate)

If you have to take an MAOI while taking Stalevo, your doctor can determine if another type of MAOI (called a selective MAOI) is safe for you.

Stalevo and drugs metabolized by catechol-O-methyltransferase (COMT)

Stalevo may interact with drugs that are broken down by COMT. COMT is an enzyme that breaks down levodopa in the body. Taking Stalevo with these drugs may increase in your blood pressure, increase your heart rate, or cause irregular heartbeats.

Examples of drugs that are metabolized by COMT include:

• epinephrine (Adrenaline), which is used to treat severe allergic reaction
• norepinephrine (Levophed), which is used for low blood pressure in a medical emergency
• dobutamine (Dobutrex, Inotrex), which is used for heart failure
• alpha-methyldopa (Aldomet), which is used for high blood pressure

If you need to take these types of drugs with Stalevo, your doctor will closely monitor your heart function and blood pressure during treatment.

Stalevo and drugs that lower your blood pressure

Stalevo can interact with blood pressure drugs. Stalevo may cause low blood pressure on its own, so taking it with a blood pressure drug may make this side effect worse. Taking these drugs with Stalevo may cause hypotension (low blood pressure).

Examples of drugs that lower your blood pressure include:

• amlodipine besylate (Norvasc, Lotrel)
• diltiazem hydrochloride (Cardizem CD, Tiazac)
• carvedilol (Coreg)
• metoprolol tartrate (Lopressor)
• lisinopril (Prinivil, Zestril)

If you must take blood pressure medication during your Stalevo treatment, your doctor will closely monitor your blood pressure.

Stalevo and tricyclic antidepressants

Stalevo can interact with a class of drugs called tricyclic antidepressants (TCAs). These drugs are typically used to treat depression, fibromyalgia, chronic pain, and other conditions.

Taking Stalevo with TCAs may cause hypotension (low blood pressure). It can also worsen dyskinesia (uncontrolled or sudden body movements).

Examples of TCAs include:

• amitriptyline (Elavil)
• imipramine (Tofranil)
• nortriptyline (Pamelor)

If you have to take a TCA while using Stalevo, your doctor will closely monitor your blood pressure and your Parkinson’s symptoms during treatment.

Stalevo and dopamine D2 receptor antagonists

Stalevo can interact with certain drugs called dopamine D2 receptor antagonists. Taking Stalevo with these drugs may lower the effect of levodopa in your body. (Levodopa is one of the active drugs in Stalevo.) This means Stalevo may be less effective. D2 antagonist drugs are most commonly used for heartburn or psychosis (loss of touch with reality).

Examples of dopamine D2 receptor antagonists include:

• metoclopramide (Reglan), which is used for heartburn
• risperidone (Risperdal, Risperdal Consta), which is used to treat schizophrenia or bipolar disorder

If you need to use a dopamine D2 receptor antagonist during your Stalevo treatment, your doctor will closely monitor your Parkinson’s symptoms. Your doctor may need to increase your dose of Stalevo while you take a dopamine D2 receptor antagonist.

Stalevo and isoniazid

Isoniazid is an antibiotic used to treat tuberculosis (TB). Taking Stalevo with isoniazid may lower the effect of levodopa in your body. (Levodopa is one of the active drugs in Stalevo.)

If you have to take isoniazid while you’re using Stalevo, your doctor will closely monitor your Parkinson’s symptoms during treatment. Your doctor may need to increase your dose of Stalevo while you’re taking isoniazid.

Stalevo and phenytoin

Taking Stalevo with phenytoin (a seizure drug) may lower or reverse the effect of levodopa in your body. (Levodopa is one of the active drugs in Stalevo.)

If you need to take phenytoin while you’re using Stalevo, your doctor will closely monitor your Parkinson’s symptoms during treatment. Your doctor may need to increase your dose of Stalevo while you’re taking phenytoin.

Stalevo and papaverine

Papaverine is a drug used to help improve blood flow in people with heart spasms. Taking Stalevo with papaverine may lower the effect of levodopa in your body. (Levodopa is one of the active drugs in Stalevo.)

If you have to take papaverine while you’re using Stalevo, your doctor will closely monitor your Parkinson’s symptoms during treatment. Your doctor may need to increase your dose of Stalevo while you take papaverine.

Stalevo and drugs that interfere with bile elimination and glucuronidation pathway in the body

Stalevo can interact with drugs that effect how your body eliminates bile or that have an effect on the glucuronidation process.* (Bile is a fluid made by the liver and stored in the gallbladder.) Entacapone, one of the active drugs in Stalevo, is eliminated through bile.

Some drugs that have this effect in your body may cause entacapone to be less effective. Other drugs may cause too much entacapone to stay in your system. This could cause certain side effects of Stalevo to be worse than usual.

Examples of drugs that affect bile elimination or glucuronidation include:

• probenecid, which is used for gout
• cholestyramine, which is used for high cholesterol
• certain antibiotics, including erythromycin, rifampicin, ampicillin, and chloramphenicol

If you have to take one of these drugs during your Stalevo treatment, your doctor will closely monitor your Parkinson’s symptoms. Your doctor may need to increase or decrease your Stalevo dose while you’re taking these other treatments.

* The glucuronidation process helps certain drugs break down. This process allows drugs to leave your body through your bile (called bile elimination) or through the kidneys.

Stalevo and drugs that work by a CYP2C9 pathway (including warfarin)

Stalevo may interact with certain drugs that work by a CYP2C9 pathway. Your body uses an enzyme called CYP2C9 to break down certain medications. Taking Stalevo with drugs that use this pathway may affect how CYP2C9 drugs are broken down in your body.

Examples of drugs that work by a CYP2C9 pathway include warfarin (Coumadin). Warfarin is commonly used to treat and prevent blood clots. Blood clots can cause heart attack, stroke, and other serious conditions.

Taking Stalevo with warfarin raises your risk for bleeding, which can be life threatening.

If you must take warfarin with Stalevo, talk with your doctor. They’ll monitor you closely during treatment and will adjust your warfarin dosage if needed. Your doctor may also recommend a treatment other than warfarin that may be safer to use with Stalevo.

Stalevo and herbs and supplements

Stalevo may interact with supplements that contain iron. This is because supplements with iron may decrease the amount of levodopa your body absorbs, and Stalevo contains levodopa.

Therefore, taking your dose of Stalevo with a multivitamin or supplement that contains iron may cause your dose of Stalevo to be less effective.

If you need to take a multivitamin or supplement that contains iron while you’re taking Stalevo, talk with your doctor about the best time to take each treatment.

Stalevo and foods

There aren’t any foods that have been specifically reported to interact with Stalevo. However, eating foods that are high in protein may make your body less able to absorb levodopa (one of the active drugs in Stalevo). This could make the drug less effective. If you’re considering changing your diet, talk with your doctor first. They can advise whether your treatment will be affected.

If you have any questions about eating certain foods with Stalevo, talk with your doctor.

Stalevo and lab tests

Stalevo may affect the results of certain lab tests. Lab tests with results that may not be accurate while you’re taking Stalevo include:

• liver function test
• blood urea nitrogen (BUN) test
• Coombs test
• creatinine blood test
• uric acid test
• urine test to measure ketone levels
• tests to check for pheochromocytoma

If you have any of these tests done during your Stalevo treatment, tell the healthcare professional performing the test that you’re taking Stalevo. This may help them more accurately interpret your lab results.

Stalevo cost

As with all medications, the cost of Stalevo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Stalevo, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Stalevo, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Stalevo, help may be available.

Medicine Assistance Tool lists programs that may help lower the cost of Stalevo. For more information and to find out if you’re eligible for support, visit their website.

Generic version

Stalevo is available in a generic form called carbidopa, levodopa, and entacapone. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. And generics tend to cost less than brand-name drugs.

If your doctor has prescribed Stalevo and you’re interested in using carbidopa, levodopa, and entacapone instead, talk with your doctor. They may have a preference for one version or the other. You’ll also need to check your insurance plan, as it may only cover one or the other.

How to take Stalevo

Stalevo comes as tablets that are taken by mouth. You should take Stalevo according to your doctor’s or healthcare provider’s instructions.

When to take

Stalevo is taken by mouth, typically multiple times per day. How often you take Stalevo will depend on your condition.

It’s recommended that you take your Stalevo doses around the same time each day. For more information about taking your Stalevo doses, see the “Stalevo dosage” section above.

If you have questions about how to time your doses to get the most benefit from your treatment, talk with your doctor.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Stalevo with food

Stalevo can be taken with or without food.

Can Stalevo be crushed, split, or chewed?

No. You should not crush, split, or chew Stalevo. Stalevo should be swallowed whole. If you have trouble swallowing the Stalevo tablets, talk with your doctor or pharmacist.

Stalevo and pregnancy

It isn’t known if Stalevo is safe to use during pregnancy. Animal studies have not shown any risk to developing fetuses when Stalevo was given to pregnant females. However, animal studies don’t always predict what will happen with humans.

If you become pregnant or think you may be pregnant while you’re taking Stalevo, talk with your doctor right away. They can recommend a safe treatment plan for you.

Stalevo and birth control

It’s not known if Stalevo is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Stalevo.

For more information about taking Stalevo during pregnancy, see the “Stalevo and pregnancy” section above.

Stalevo and breastfeeding

Stalevo is not recommended while breastfeeding. Levodopa, an active drug in Stalevo, is known to pass into human breast milk. And there’s a possibility that the drug could cause harm in a breastfed child. Because of this, other drugs may be preferred over Stalevo if you’re breastfeeding.

If you’re breastfeeding or planning to breastfeed, talk with your doctor about the risks and benefits of using Stalevo.

Common questions about Stalevo

Here are answers to some frequently asked questions about Stalevo.

Does Stalevo cure Parkinson’s disease?

No, Stalevo doesn’t cure Parkinson’s disease (PD). There’s currently no cure for this condition.

Stalevo is approved to help manage PD symptoms in certain situations. For more information on how the drug is used, see the “Stalevo for Parkinson’s disease” section above.

If you have questions about what to expect from Stalevo treatment, talk with your doctor.

Can I drive while I’m taking Stalevo?

It may be possible to drive while taking Stalevo. But you should see how Stalevo affects you before driving. Whether you can drive while taking Stalevo will depend on how you react to the drug. Talk with your doctor before driving while using Stalevo.

Stalevo has several possible side effects that may make it unsafe for you to drive or operate machinery. These include sleepiness, falling asleep during activities, and having dyskinesia (uncontrolled or sudden body movements).

Your doctor may want to monitor you and see how your medication affects you before determining if you can drive. Talk with your doctor if you have any questions about driving during your treatment.

Over time, will Stalevo’s effects begin to wear off sooner?

It’s possible that Stalevo’s effects will wear off sooner the longer you take it. The drug’s effects may also wear off sooner as your PD progresses (gets worse). When a drug’s effects begin to wear off and your PD symptoms return, it’s called an “off period.” Off periods may occur with Stalevo.

An off period typically happens before you’re scheduled to take your next dose of the drug. During these times, symptoms that may return include rigid muscles and dyskinesia (uncontrolled or sudden body movements).

Talk with your doctor if you have concerns about experiencing off periods during your Stalevo treatment.

Is Stalevo safe for older people to take?

It’s not known if Stalevo is safe for use in people older than age 75 years. This is because Stalevo hasn’t been studied in this age group.

If you’re older than 75 years and are interested in taking Stalevo, talk with your doctor. They may want to monitor you more closely during your treatment.

Can I stop taking Stalevo suddenly?

No. Stopping Stalevo suddenly may cause side effects such as a fever of more than 106.7°, confusion , and trouble thinking clearly.

If you need to stop taking Stalevo, talk with your doctor. They’ll recommend a treatment plan to help you safely stop taking this drug. Typically, your doctor will gradually reduce your dosage over a period of time until it’s safe for you to completely stop treatment.

Will I develop movement problems or muscle spasms if I use Stalevo long term?

It’s not known if long-term use of Stalevo can cause movement problems and muscle spasms. These side effects can occur in some people taking Stalevo. However, it’s not known if Stalevo is the cause of these side effects. They may also be due to Parkinson’s disease itself.

Talk with your doctor if you’re concerned about developing movement problems or muscle spasms. They may have suggestions on how to lower your risk for these side effects.

Stalevo precautions

Before taking Stalevo, talk with your doctor about your health history. Stalevo may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Liver problems. If you currently have liver problems (such as liver disease) or have had liver problems in the past, your body may not break down Stalevo like it should. Talk with your doctor about whether you can take Stalevo. They may monitor your liver more closely during your treatment.
• Peptic ulcer disease (PUD). If you have a history of peptic ulcers, certain drugs such as Stalevo may raise your risk for new ulcers. Talk with your doctor to see if a different medication may be better to treat your Parkinson’s symptoms.
• Depression or thoughts of suicide. Stalevo can cause depression or thoughts of suicide. Tell your doctor if you’ve had depression or thoughts of suicide in the past. Another medication may be a better fit for you than Stalevo.
• Allergic reaction. If you’ve had an allergic reaction to Stalevo or any of its ingredients, you shouldn’t take Stalevo. Ask your doctor about other medications that may be better options for you.
• Pregnancy. It’s not known if Stalevo is safe to use during pregnancy. For more information, see the “Stalevo and pregnancy” section above.
• Breastfeeding. It’s not recommended to use Stalevo while breastfeeding. For more information, see the “Stalevo and breastfeeding” section above.

Note: For more information about the potential negative effects of Stalevo, see the “Stalevo side effects” section above.