Stalevo 75

Name: Stalevo 75

What is Stalevo 75 (carbidopa, entacapone, and levodopa)?

Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels of dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect. Entacapone increases levels of levodopa in the body.

The combination of carbidopa, entacapone, and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control.

Carbidopa, entacapone, and levodopa may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Stalevo 75 (carbidopa, entacapone, and levodopa)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have:

  • narrow-angle glaucoma;

  • unusual skin lesions that have not been checked by a doctor; or

  • a history of malignant melanoma (skin cancer).

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, or a prior heart attack;

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

  • kidney disease, liver disease, or bile duct obstruction;

  • an endocrine (hormonal) disease;

  • a stomach or intestinal ulcer;

  • glaucoma; or

  • depression or other mental illness.

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

Carbidopa, entacapone, and levodopa may cause hallucinations (the sensation of hearing or seeing something that is not there). Call your doctor if you experience hallucinations.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether carbidopa, entacapone, and levodopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Carbidopa, entacapone, and levodopa may pass into breast milk and could harm a nursing baby. You should not breast-feed while you are taking carbidopa, entacapone, and levodopa.

What other drugs will affect Stalevo 75 (carbidopa, entacapone, and levodopa)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbidopa, entacapone, and levodopa. Tell your doctor if you regularly use any of these other medicines, or any other Parkinson's medications.

Tell your doctor about all other medicines you use, especially:

  • apomorphine (Apokyn);

  • cholestyramine (Prevalite, Questran);

  • dobutamine (Dobutrex);

  • epinephrine (Epi-Pen, and others);

  • isoniazid (for treating tuberculosis);

  • isoproterenol (Isuprel, Medihaler-Iso);

  • methyldopa (Aldomet);

  • metoclopramide (Reglan);

  • papaverine (Pavabid, Papacon, Pavagen, Pavacot);

  • phenytoin (Dilantin);

  • probenecid (Benemid);

  • blood pressure medication;

  • an antibiotic such as ampicillin, chloramphenicol, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others), or rifampin (Rifadin, Rifater, Rifamate);

  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or

  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine), risperidone (Risperdal), and others.

This list is not complete and other drugs may interact with carbidopa, entacapone, and levodopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Uses For Stalevo 75

Carbidopa, entacapone, and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa (a component of this medicine) enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils.

This medicine is a combination of three different medicines. This medicine is known as a levodopa therapy. The difference between this medicine and other levodopa treatments is that this medicine contains entacapone. Entacapone helps levodopa last longer by blocking a substance called COMT enzyme. This enzyme breaks down levodopa before it reaches the brain. When less levodopa is broken down, more is available to the brain. Increased availability of levodopa may lead to smoother and steadier levels of dopamine in the brain, which may provide better symptom control for longer periods each day. This may lead to improvement in daily activities.

This medicine is available only with your doctor's prescription.

Proper Use of carbidopa, entacapone, and levodopa

This section provides information on the proper use of a number of products that contain carbidopa, entacapone, and levodopa. It may not be specific to Stalevo 75. Please read with care.

Take this medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.

Swallow the tablet whole. Do not crush, chew, or break it. You may take the tablet with or without food.

Since protein may interfere with the body's response to levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.

This medicine begins to release its ingredients 30 minutes after you take it.

If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules or tablets):
    • For Parkinson's disease:
      • Adults—The starting dose is usually the same as the current dose you are taking. If you are starting this medicine for the first time, your doctor may want to start you on a carbidopa and levodopa combination with entacapone and gradually switch you over to this combination. Do not use more than 6 to 8 tablets in a 24-hour period.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Stalevo 75

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®] or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, drowsiness, trouble in controlling movements, or trouble in concentrating or seeing clearly. It may even cause you to fall asleep without warning while you drive, talk, or eat. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medications, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

Check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.

It is possible that you may become nauseous, especially when you are first starting your medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Stalevo 75 Side Effects

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
  • constipation
  • constricted pupil
  • convulsions
  • cough
  • difficult or labored breathing
  • difficulty with speaking
  • drooling
  • 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
  • nausea
  • pain
  • 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
  • sore throat
  • 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:

More common-Entacapone
  • Absence of or decrease in body movement
  • diarrhea
  • dizziness
  • urine discoloration
Less common-Entacapone
  • Acid or sour stomach
  • anxiety
  • belching
  • bitter, sour, or unusual taste in the mouth
  • bloated
  • burning feeling in the chest or stomach
  • dry mouth
  • excess air or gas in the stomach or intestines
  • fear
  • full feeling
  • heartburn
  • 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
  • hair loss
  • 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
  • nasal congestion
  • 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
  • runny nose
  • sense of stimulation
  • skin rash
  • sleeplessness
  • slow movement
  • slow or fast heartbeat
  • slow reflexes
  • sneezing
  • swelling
  • tremor, increased
  • trouble concentrating
  • trouble recognizing objects
  • trouble thinking and planning
  • urinary frequency
  • urinary retention
  • weight gain
  • weight loss

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.

In Summary

Common side effects of Stalevo 75 include: diarrhea, dyskinesia, hyperkinesia, nausea, dark urine, and urine discoloration. Other side effects include: abdominal pain, and vomiting. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to carbidopa / entacapone / levodopa: oral tablet

Nervous system

Nervous system side effects most commonly reported with carbidopa-levodopa-entacapone have included dyskinesias (choreiform, dystonic, and involuntary movements) and headache. Hyperkinesia, hypokinesia, and dizziness have been reported with entacapone.

Convulsions have also been reported; however, a causal relationship with carbidopa-levodopa has not been established.[Ref]

Ocular

Ocular side effects reported with various carbidopa-levodopa products have included blurred vision, dilated pupils, diplopia, and oculogyric crisis.[Ref]

Psychiatric

Psychiatric side effects have included reports of psychotic episodes (including delusions, hallucinations, and paranoid ideation), agitation, anxiety, confusion, dream abnormalities including nightmares, depression (with or without development of suicidal tendencies), somnolence, and dementia.[Ref]

Respiratory

Respiratory side effects have included dyspnea, upper respiratory infection, pharyngeal pain, cough, pharyngitis, and rhinitis.[Ref]

Cardiovascular

Cardiovascular side effects have included reports of cardiac irregularities, myocardial infarction, and orthostatic effects (hypotension, hypertension, and syncope), and palpitations.[Ref]

Dermatologic

Dermatologic side effects have included rash, increased sweating, alopecia, dark sweat, and malignant melanoma.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects have included dark saliva, GI bleeding, development of duodenal ulcer, abdominal pain, anorexia, nausea, vomiting, diarrhea, constipation, dyspepsia, dry mouth, dysphagia, sialorrhea, flatulence, gastritis, taste alterations, heartburn, and hiccups.[Ref]

Hematologic

Hematologic side effects have included hemolytic and nonhemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia, and purpura. Laboratory abnormalities reported have included decreased hemoglobin and hematocrit, serum potassium, Coombs' test, lactic dehydrogenase, bilirubin, and blood urea nitrogen (BUN); and elevated serum glucose.[Ref]

Hypersensitivity

Hypersensitivity side effects have included angioedema, urticaria, pruritus, and Henoch-Schonlein purpura, bullous lesions (with pemphigus- like reactions).[Ref]

Musculoskeletal

Musculoskeletal side effects have included asthenia, fatigue, back pain, shoulder pain, leg pain, and muscle cramps.[Ref]

Genitourinary

Genitourinary side effects have included dark urine, blood in the urine, urinary incontinence, urinary retention, urinary tract infection, and priapism,[Ref]

Hepatic

Hepatic side effects have included abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), and lactic dehydrogenase.[Ref]

Renal

Renal side effects have included increases in serum creatinine and uric acid.[Ref]

Metabolic

Metabolic side effects have included edema, weight gain, and weight loss.[Ref]

Some side effects of Stalevo 75 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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