Stalevo

Last updated on RxList: 8/2/2021
Stalevo Side Effects Center

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.

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
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)

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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 carbidopalevodopa- entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, dry mouth, and urine discoloration.

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 Adverse Reaction Carbidopa/levodopa plus Entacapone
(n=603) % of patients
Carbidopa/levodopa plus Placebo
(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 CLOTTINGDISORDERS
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.

DRUG INTERACTIONS

MAO Inhibitors

Patients receiving nonselective MAO inhibitors and carbidopa, levodopa and entacapone may be at risk of increased adrenergic tone. Therefore, the use of Stalevo is contraindicated in patients receiving nonselective MAO inhibitors [see CONTRAINDICATIONS].

Drugs Metabolized By Catechol-O-Methyltransferase (COMT)

Drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine, and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of administration (including inhalation), as their interaction may result in increased heart rates, possibly arrhythmias, and excessive changes in blood pressure [see WARNINGS AND PRECAUTIONS].

Antihypertensive Agents

Symptomatic postural hypotension has occurred when carbidopa/levodopa was added to the treatment of patients receiving antihypertensive drugs. When starting therapy with Stalevo, dosage adjustment of antihypertensive drug may be required.

Tricyclic Antidepressants

There have been reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa/levodopa.

Dopamine D2 Receptor Antagonists

Dopamine D2 receptor antagonists (e.g., metoclopramide, phenothiazines, butyrophenones, risperidone) may reduce the therapeutic effects of levodopa.

Isoniazid

Isoniazid may reduce the therapeutic effects of levodopa, a dose increase may be necessary.

Phenytoin

The beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin. Patients taking phenytoin with carbidopa/levodopa should be carefully observed for loss of therapeutic response. Stalevo dosage should be increased as clinically needed in patients receiving phenytoin.

Papaverine

The beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by papaverine. Patients taking papaverine with carbidopa/levodopa should be carefully observed for loss of therapeutic response. Stalevo dosage should be increased as clinically needed in patients receiving papaverine.

Iron Salts

Iron salts or multi vitamins containing iron salts should be coadministered with caution. Iron salts can form chelates with levodopa, carbidopa and entacapone and consequently reduce bioavailability of levodopa, carbidopa and entacapone.

Drugs Known To Interfere With Biliary Excretion, Glucuronidation, And Intestinal Beta-glucuronidase

As most entacapone excretion is via the bile, caution should be exercised when drugs known to interfere with biliary excretion, glucuronidation, and intestinal beta-glucuronidase are given concurrently with entacapone. These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol).

Drugs Metabolized Via CYP2C9 (e.g., coumadin)

The dosage of Stalevo should be adjusted as clinically needed in patients using other drugs metabolized via CYP2C9. An interaction study in healthy volunteers, entacapone increased the AUC of R-warfarin on average by 18%, and the INR values on average by 13%. Cases of increased INR in patients concomitantly using warfarin have been reported during the post-approval use of entacapone. Thus, monitoring of INR is recommended when Stalevo treatment is initiated for patients receiving warfarin.

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

© 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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