Stalevo

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Stalevo


Generic Name: Carbidopa/Entacapone/Levodopa Tablets (KAR-bi-DOE-pa/en-TA-ka-pone/lee-voe-DOE-pa)
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 amounts of dopamine in the brain. By increasing the amounts of dopamine in the brain, the chemicals of the brain become more balanced and the symptoms of these diseases 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 a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

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, plan 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 or other substances
  • if you have a history of heart problems or heart attack, blood pressure problems, lung problems (eg, asthma), kidney or liver problems, or mood or mental disorders
  • 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:

  • Ampicillin, chloramphenicol, cholestyramine, erythromycin, probenecid, or rifampicin because side effects of Stalevo may be increased
  • Furazolidone, MAO inhibitors (eg, phenelzine), selegiline, or tricyclic antidepressants (eg, amitriptyline) because serious side effects (eg, headache, very high blood pressure, abnormal heartbeat) may occur
  • Apomorphine, butyrophenones (eg, haloperidol), hydantoins (eg, phenytoin), isoniazid, metoclopramide, papaverine, phenothiazines (eg, chlorpromazine), or risperidone because effectiveness of Stalevo may be decreased
  • Sympathomimetics (eg, phenylephrine) because side effects may be increased by Stalevo
  • Digoxin and iron salts (eg, ferrous sulfate) because 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.

  • Stalevo may be taken with or without food. If upset stomach 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).
  • 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 light-headedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Stalevo . Using Stalevo alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Stalevo . Stalevo will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • 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.
  • Stalevo may discolor the saliva, urine, or sweat a dark color (red, brown, or black). This is normal and not a cause for concern.
  • Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome sometimes associated with Stalevo . Symptoms may include increased body heat; rigid muscles; altered mental abilities, including lack of response to your surroundings; fast or irregular heartbeat; sweating. Contact your doctor at once if any of these symptoms occur.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Stalevo .
  • Diabetic patients - Stalevo may cause false test results with some urine glucose tests.
  • LAB TESTS, including complete blood cell counts and heart, liver, and kidney function tests, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
  • Use Stalevo with extreme caution in the ELDERLY because they may be more sensitive to its effects.
  • Stalevo is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Stalevo during pregnancy. It is unknown if Stalevo is excreted in breast milk. If you are or will be breast-feeding while you are using Stalevo , check with your doctor or pharmacist to discuss the 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; 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; fever; hallucinations; increased or irregular heart beat; lack of response to environment; mental changes; paranoia; rigid muscles; seizures; severe abdominal pain; severe or persistent diarrhea; stomach pain; trouble sleeping; unusual or painful movements of face, eyelids, mouth, tongue, arms, hands, or legs; unusual sweating; vomiting; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), 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 room temperature, between 59 and 86 degrees F (15 and 30 degrees C). 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.

This information is a summary only. It does not contain all information about Stalevo . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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