Generic Name: carbidopa/levodopa/entacapone (KAR-bi-DOE-pa/LEE-voe-DOE-pa/en-TAK-a-pone)
Brand Name: Stalevo

Stalevo is used for:

Treating symptoms of Parkinson disease.

Stalevo is an antidyskinetic combination of dopamine-enhancing medicines. It works by increasing the amount of dopamine in the brain. By increasing the amount of dopamine in the brain, the chemicals of the brain become more balanced and the symptoms of this disease are lessened.

Do NOT use Stalevo if:

  • you are allergic to any ingredient in Stalevo
  • you have narrow-angle glaucoma, skin growths of unknown cause, skin cancer, or a history of skin cancer
  • you have taken furazolidone or certain monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Stalevo:

Some medical conditions may interact with Stalevo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems (eg, irregular heartbeat) or a heart attack, blood pressure problems, endocrine problems, fainting, lung problems (eg, asthma), kidney or liver problems, neuroleptic malignant syndrome (NMS), a severe muscle problem called rhabdomyolysis, glaucoma or increased pressure in the eye, or mood or mental problems (eg, depression)
  • if you have stomach or intestinal problems (eg, ulcers), or biliary or gallbladder problems

Some MEDICINES MAY INTERACT with Stalevo. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Furazolidone, MAOIs (eg, phenelzine), selegiline, or tricyclic antidepressants (eg, amitriptyline) because serious side effects (eg, headache, very high blood pressure, abnormal heartbeat) may occur
  • Ampicillin, chloramphenicol, cholestyramine, erythromycin, metoclopramide, probenecid, rifampin, or sympathomimetics (eg, phenylephrine) because they may increase the risk of Stalevo's side effects
  • Apomorphine, butyrophenones (eg, haloperidol), hydantoins (eg, phenytoin), isoniazid, metoclopramide, papaverine, phenothiazines (eg, chlorpromazine), or risperidone because they may decrease Stalevo's effectiveness
  • Medicines for blood pressure because the risk of their side effects may be increased by Stalevo
  • Digoxin and iron salts (eg, ferrous sulfate) because their effectiveness may be decreased by Stalevo

This may not be a complete list of all interactions that may occur. Ask your health care provider if Stalevo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Stalevo:

Use Stalevo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Stalevo by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow Stalevo whole. Do not break, crush, or chew before swallowing.
  • Take Stalevo at least 4 hours before or after taking iron salts (eg, ferrous sulfate).
  • Diets that are high in protein may decrease your body's ability to absorb Stalevo. Discuss any questions or concerns with your doctor. Tell your doctor if you have a diet that is high in protein, or if you will be changing your diet to include more protein.
  • Do not suddenly stop taking Stalevo without checking with your doctor. Side effects may occur. They may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating.
  • If you miss a dose of Stalevo, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Stalevo.

Important safety information:

  • Stalevo may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Stalevo with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Stalevo; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Stalevo may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Diets high in protein may prevent your body's ability to absorb Stalevo. Dietary protein should be eaten evenly throughout the day.
  • Gradually increase physical activity as your symptoms improve.
  • A "wearing-off" effect may occur before you need to take your next dose of Stalevo. If this effect becomes bothersome, contact your doctor.
  • Stalevo may cause diarrhea. It typically begins within 4 to 12 weeks of starting Stalevo, but may occur during the first week or many months after starting it. Rare cases of prolonged diarrhea caused by colitis (inflammation of the large intestine) have occurred in patients taking Stalevo. Contact your doctor if you have severe, persistent, or watery diarrhea.
  • If diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Stalevo may discolor the saliva, urine, or sweat a dark color (red, brown, or black). This is normal and not a cause for concern.
  • Stalevo may cause nausea, especially when you first start to take it. Check with your doctor if nausea persists or is severe.
  • Stalevo may cause mental or mood changes. Contact your doctor at once if any new or worsening symptoms such as depressed mood; anxious, restless, or irritable behavior; or unusual changes in mood or behavior occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.
  • You may experience an increase in involuntary movements while taking Stalevo. Check with your doctor if this occurs.
  • NMS is a possibly fatal syndrome that can be caused by Stalevo. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Stalevo. Tell your doctor right away if you notice such effects.
  • Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Stalevo also increases the risk of melanoma. You may need to have skin exams while you are using Stalevo. Discuss any questions or concerns with your doctor.
  • Tell your doctor or dentist that you take Stalevo before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Stalevo may cause the results of some tests for urine glucose or urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
  • Stalevo may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Stalevo.
  • Lab tests, including complete blood cell counts and heart, liver, and kidney function, may be performed while you use Stalevo. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Stalevo with extreme caution in the ELDERLY; they may be more sensitive to its effects.
  • Stalevo should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stalevo while you are pregnant. It is not known if Stalevo is found in breast milk. If you are or will be breast-feeding while you use Stalevo, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Stalevo:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; depression with thoughts of suicide; fainting; fast or irregular heartbeat; fever; hallucinations; lack of response to environment; mental or mood changes; muscle pain, stiffness, or rigidity; new or increased involuntary movements; paranoia; seizures; severe or persistent dizziness; severe, persistent, or watery diarrhea; shortness of breath; stomach pain; trouble sleeping; unusual or painful movements of the face, eyelids, mouth, tongue, arms, hands, or legs; unusual skin growths or change in the appearance of a mole; unusual sweating; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; confusion; dark urine or trouble urinating; fast or irregular heartbeat; high blood pressure; insomnia; muscle spasms; restlessness.

Proper storage of Stalevo:

Store Stalevo at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, moisture, and light. Keep in a tight, light-resistant container. Do not store in the bathroom. Keep Stalevo out of the reach of children and away from pets.

General information:

  • If you have any questions about Stalevo, please talk with your doctor, pharmacist, or other health care provider.
  • Stalevo is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Stalevo or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Stalevo. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Stalevo. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Stalevo.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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