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Stalevo

Last reviewed on RxList: 1/8/2020
Stalevo Side Effects Center

Last reviewed on RxList 1/08/2020

What Is Stalevo?

Stalevo (carbidopa, levodopa and entacapone) is a combination of several medications used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control. Levodopa is converted to a chemical called dopamine in the brain. Symptoms of Parkinson's disease may be caused by low levels dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect. When used with carbidopa and levodopa, entacapone increases levels of levodopa in the body.

What Are Side Effects of Stalevo?

Common side effects of Stalevo include:

Tell your doctor if you have serious side effects of Stalevo including:

  • involuntary movements (especially twitching of the eyelid),
  • fainting or falling,
  • difficulty swallowing,
  • stomach/abdominal pain,
  • persistent diarrhea,
  • vision changes (including blurred vision),
  • black/tarry stools,
  • muscle pain,
  • changes in the amount of urine,
  • mental/mood changes (such as confusion, hallucinations, thoughts of suicide),
  • signs of infection (e.g., persistent sore throat), or
  • unusual strong urges (such as increased gambling, increased sexual urges).

Dosage for Stalevo

The optimum daily dosage of Stalevo must be determined for each patient. Therapy should be individualized and adjusted according to the desired therapeutic response.

What Drugs, Substances, or Supplements Interact with Stalevo?

Stalevo may interact with apomorphine, cholestyramine, dobutamine, epinephrine, isoniazid, isoproterenol, methyldopa, metoclopramide, papaverine, phenytoin, probenecid, antibiotics, blood pressure medication, antidepressants, medicines to treat psychiatric disorders, cold or allergy medicine, narcotics, sleeping pills, muscle relaxers, medicine for seizures, or anti-anxiety medications. Tell your doctor all medications you are taking.

Stalevo During Pregnancy and Breastfeeding

Stalevo should be used only when prescribed during pregnancy. Levodopa passes into breast milk. It is unknown if carbidopa or entacapone pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Stalevo (carbidopa, levodopa and entacapone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Stalevo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • depressed mood, thoughts about hurting yourself;
  • hallucinations, unusual behaviors;
  • severe nausea and vomiting;
  • severe or ongoing diarrhea, diarrhea that is watery;
  • unexplained muscle pain, tenderness, or weakness;
  • a light-headed feeling, like you might pass out;
  • fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats.

This medicine may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Common side effects may include:

  • involuntary muscle movement;
  • diarrhea;
  • nausea, vomiting, stomach pain;
  • discolored urine; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Stalevo (Carbidopa, Levodopa and Entacapone)

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
Stalevo Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling:

  • Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
  • Hypotension/Orthostatic Hypotension and Syncope [see WARNINGS AND PRECAUTIONS]
  • Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Depression and suicidality [see WARNINGS AND PRECAUTIONS]
  • Hallucinations/Psychotic-Like Behavior [see WARNINGS AND PRECAUTIONS]
  • Impulse Control and/or Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
  • Diarrhea and Colitis [see WARNINGS AND PRECAUTIONS]
  • Rhabdomyolysis [see WARNINGS AND PRECAUTIONS]
  • Peptic Ulcer Disease [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment/total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in clinical practice.

Entacapone

The most commonly observed adverse reactions (incidence at least 3% greater than placebo incidence) in the double-blind, carbidopa-levodopa-placebo-controlled trials of entacapone (N=1,003 patients) associated with the use of carbidopa-levodopa-entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia, urine discoloration, diarrhea, nausea, hyperkinesia, vomiting, and dry mouth.

The treatment difference incidence for premature study discontinuation for entacapone with levodopa and dopa decarboxylase inhibitor in the double-blind, placebo-controlled trials was 5%. The treatment difference incidence for the most frequent causes of study discontinuation was 2% for diarrhea, and 1% for other specific adverse reactions including psychiatric reasons, dyskinesia/ hyperkinesia, nausea, or abdominal pain.

Adverse Reaction Incidence In Controlled Clinical Studies Of Entacapone

Table 2 lists treatment emergent adverse reactions that occurred in at least 1% of patients treated with carbidopa/levodopa and 200 mg of entacapone who participated in the double-blind, placebo-controlled studies, and that were numerically more common in this group than in the carbidopa/levodopa plus placebo group. In these studies, either entacapone or placebo was added to carbidopa/levodopa (or benserazide/levodopa).

Table 2: Summary of Patients With Adverse Reactions After Start of Trial Drug Administration At Least 1% in Entacapone Group and Greater Than Placebo

SYSTEM ORGAN CLASS Carbidopa/ levodopa plus Entacapone Carbidopa/ levodopa plus Placebo
Preferred Term (n=603)
% of patients
(n=400)
% of patients
SKIN AND APPENDAGES DISORDERS
  Sweating Increased 2 1
MUSCULOSKELETAL SYSTEM DISORDERS
  Back Pain 5 3
CENTRAL AND PERIPHERAL NERVOUS SYSTEM DISORDERS
  Dyskinesia 25 15
  Hyperkinesia 10 5
  Hypokinesia 9 8
  Dizziness 8 6
SPECIAL SENSES, OTHER DISORDERS
  Taste Perversion 1 0
PSYCHIATRIC DISORDERS
  Anxiety 2 1
  Somnolence 2 0
  Agitation 1 0
GASTROINTESTINAL SYSTEM DISORDERS
  Nausea 14 8
  Diarrhea 10 4
  Abdominal Pain 8 4
  Constipation 6 4
  Vomiting 4 1
  Mouth Dry 3 0
  Dyspepsia 2 1
  Flatulence 2 0
  Gastritis 1 0
  Gastrointestinal Disorders NOS 1 0
RESPIRATORY SYSTEM DISORDERS
  Dyspnea 3 1
PLATELET, BLEEDING AND CLOTTING DISORDERS
  Purpura 2 1
URINARY SYSTEM DISORDERS
  Urine Discoloration 10 0
BODY AS A WHOLE-GENERAL DISORDERS
  Fatigue 6 4
  Asthenia 2 1
RESISTANCE MECHANISM DISORDERS
  Infection Bacterial 1 0

Postmarketing Experience

The following spontaneous reports of adverse events temporally associated with entacapone or Stalevo have been identified since market introduction and are not listed in Table 2. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish causal relationship to entacapone or Stalevo exposure.

Hepatitis with mainly cholestatic features has been reported.

Effects Of Gender And Age On Adverse Reactions

No differences were noted in the rate of adverse reactions attributable to entacapone alone by age or gender.

Read the entire FDA prescribing information for Stalevo (Carbidopa, Levodopa and Entacapone)

Related Resources for Stalevo

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Read the Stalevo User Reviews »

© Stalevo Patient Information is supplied by Cerner Multum, Inc. and Stalevo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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