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Stalevo

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Stalevo

Stalevo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Stalevo (carbidopa, levodopa and entacapone) is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control. Stalevo is a combination of several medications. 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. Common side effects include diarrhea, nausea, vomiting, headache, dizziness, drowsiness, stomach upset, loss of appetite, dry mouth, or difficulty sleeping.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Stalevo in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);
  • depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;
  • worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • fast, pounding, or uneven heartbeats;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;
  • tight feeling in your chest, new or worsening cough, fever, trouble breathing;
  • easy bruising or bleeding, bloody or tarry stools, coughing up blood;
  • pain or burning when you urinate; or
  • unexplained muscle pain, tenderness, or weakness.

Less serious side effects may include:

  • stomach pain or upset, loss of appetite, constipation;
  • dry mouth, changes in your sense of taste;
  • unusual skin changes. mild rash or itching;
  • dizziness or drowsiness, headache, blurred vision;
  • muscle cramps, back pain; or
  • agitation or anxiety, sleep problems (insomnia), strange dreams.

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.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Stalevo Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, nausea, vomiting, headache, dizziness, drowsiness, stomach upset, loss of appetite, dry mouth, or difficulty sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people using this medication have reported falling asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy.

Tell your doctor immediately if any of these serious side effects occur: involuntary movements (especially twitching of the eyelid), fainting or falling, difficulty swallowing, stomach/abdominal pain, persistent diarrhea, vision changes (including blurred vision).

Tell your doctor immediately if any of these unlikely but serious side effects occur: black/tarry stools, muscle pain, change in the amount of urine, mental/mood changes (such as confusion, hallucinations, thoughts of suicide, compulsive behavior including urge to gamble), signs of infection (e.g., persistent sore throat).

Seek immediate medical attention if any of these highly unlikely but very serious side effects occur: chest pain, high fever, severe muscle stiffness, fast heartbeat, fast breathing, increased sweating.

This medication may cause the saliva, urine, or sweat to turn a dark color. This is harmless; however, it may discolor clothing.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Stalevo (Carbidopa, Levodopa and Entacapone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Stalevo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Carbidopa-levodopa

The most common adverse reactions reported with carbidopa-levodopa have included dyskinesias, such as choreiform, dystonic, and other involuntary movements and nausea.

The following other adverse reactions have been reported with carbidopa-levodopa:

Body as a Whole: Chest pain, asthenia.

Cardiovascular: Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.

Gastrointestinal: Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations.

Hematologic: Agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia.

Hypersensitivity: Angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions).

Musculoskeletal: Back pain, shoulder pain, muscle cramps.

Nervous System/Psychiatric: Psychotic episodes including delusions, hallucinations, and paranoid ideation, neuroleptic malignant syndrome (see WARNINGS), bradykinetic episodes ("on-off' phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, increased libido. Convulsions also have occurred; however, a causal relationship with carbidopa-levodopa has not been established.

Respiratory: Dyspnea, upper respiratory infection.

Skin: Rash, increased sweating, alopecia, dark sweat.

Urogenital: Urinary tract infection, urinary frequency, dark urine.

Laboratory Tests: Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen (BUN), Coombs' test; elevated serum glucose; white blood cells, bacteria, and blood in the urine.

Other adverse reactions that have been reported with levodopa alone and with various carbidopa-levodopa formulations, and may occur with Stalevo® (carbidopa, levodopa and entacapone) are:

Body as a Whole: Abdominal pain and distress, fatigue. Cardiovascular: Myocardial infarction.

Gastrointestinal: Gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups.

Metabolic: Edema, weight gain, weight loss.

Musculoskeletal: Leg pain.

Nervous System/Psychiatric: Ataxia, extrapyramidal disorder, failing, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner's syndrome, peripheral neuropathy.

Respiratory: Pharyngeal pain, cough.

Skin: Malignant melanoma (see also CONTRAINDICATIONS), flushing.

Special Senses: Oculogyric crisis, diplopia, blurred vision, dilated pupils.

Urogenital: Urinary retention, urinary incontinence, priapism.

Miscellaneous: Bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation.

Laboratory Tests: Decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine.

Entacapone

The most commonly observed adverse events ( > 5%) in the double-blind, placebo-controlled trials of entacapone (N=1003) associated with the use of entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia/hyperkinesia, nausea, urine discoloration, diarrhea, and abdominal pain.

Approximately 14% of the 603 patients given entacapone in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared to 9% of the 400 patients who received placebo. The most frequent causes of discontinuation in decreasing order are: psychiatric reasons (2% vs. 1%), diarrhea (2% vs. 0%), dyskinesia/hyperkinesia (2% vs. 1%), nausea (2% vs. 1%), abdominal pain (1% vs. 0%), and aggravation of Parkinson's disease symptoms (1% vs. 1%).

Adverse Event Incidence in Controlled Clinical Studies of Entacapone

Table 5 lists treatment emergent adverse events that occurred in at least 1% of patients treated with entacapone participating in the double-blind, placebo-controlled studies and that were numerically more common in the entacapone group, compared to placebo. In these studies, either entacapone or placebo was added to carbidopa-levodopa (or benserazide-levodopa).

Table 5: Summary of Patients With Adverse Events After Start of Trial Drug Administration At Least 1% in Entacapone Group and > Placebo

SYSTEM ORGAN CLASS
Preferred Term
Entacapone
(n = 603)
% of patients
Placebo
(n = 400)
% of patients
SKIN AND APPENDAGES DISORDERS
  Sweating Increased 2 1
MUSCULOSKELETAL SYSTEM DISORDERS
  Back Pain 2 1
CENTRAL & 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 & CLOTTING DISORDERS
  Purpura 2 1
URINARY SYSTEM DISORDERS
  Urine Discoloration 10 0
BODY AS A WHOLE - GENERAL DISORDERS
  Back Pain 4 2
  Fatigue 6 4
  Asthenia 2 1
RESISTANCE MECHANISM DISORDERS
  Infection Bacterial 1 0

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures do, however, provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse events observed in the population studied.

Effects of Gender and Age on Adverse Reactions

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

Drug Abuse And Dependence

Controlled substance class: Stalevo (carbidopa, levodopa and entacapone) ® (carbidopa, levodopa and entacapone) is not a controlled substance.

Physical and psychological dependence: Stalevo (carbidopa, levodopa and entacapone) ® has not been systematically studied, in animal or humans, for its potential for abuse, tolerance or physical dependence. In premarketing clinical experience, carbidopa-levodopa did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. However, there are rare postmarketing reports of abuse and dependence of medications containing levodopa. In general, these reports consist of patients taking increasing doses of medication in order to achieve a euphoric state.

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

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Stalevo - User Reviews

Stalevo User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Stalevo sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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