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What is the most important information I should know about entacapone?

Use caution when driving, operating machinery, or performing other hazardous activities. Entacapone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Dizziness may be more likely to occur when rising from a sitting or lying position. To avoid falls, rise slowly from a sitting or lying position.

Hallucinations may occur with entacapone. Call your doctor if you experience hallucinations.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is entacapone?

When used with levodopa and carbidopa, entacapone increases levels of levodopa (Dopar, Larodopa, Sinemet) in the body.

Entacapone is used with carbidopa and levodopa to treat patients with Parkinson’s disease who experience the signs and symptoms of end-of-dose "wearing-off”. Entacapone is used only in combination with carbidopa and levodopa. It has no effect if it is used on its own.

Entacapone may also be used for purposes other than those listed in the medication guide.


Precautions

Do not take entacapone without first talking to your doctor if you

  • have liver disease;
  • are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate); or
  • have ever experienced muscle damage or elevated body temperature and confusion because of a medication.

You may not be able to take entacapone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Entacapone is in the FDA pregnancy category C. This means that it is not known whether entacapone will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

It is not known whether entacapone passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Use caution when driving, operating machinery, or performing other hazardous activities. Entacapone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Dizziness may be more likely to occur when you rise from a sitting or lying position. To avoid falls, rise slowly.

Avoid alcohol or use it with caution while taking entacapone. Alcohol may increase drowsiness while taking entacapone.

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Instructions

Seek emergency medical attention.

Symptoms of an entacapone overdose are not known.

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

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Side-effects

If you experience any of the following serious side effects, stop taking entacapone and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • fever and confusion;
  • muscle pain; or
  • hallucinations.

Other, less serious side effects may be more likely to occur. Notify your doctor if you experience

  • abnormal movements of the muscles;
  • nausea or vomiting;
  • discolored urine;
  • diarrhea;
  • abdominal pain;
  • dry mouth;
  • dizziness;
  • anxiety;
  • drowsiness;
  • increased sweating; or
  • shortness of breath.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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Interactions

Do not take entacapone without first talking to your doctor if you are taking a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate). These medicines should not be taken with entacapone.

Before taking entacapone, tell your doctor if you are taking

  • isoproterenol (Isuprel, Medihaler-Iso, Duo-Medihaler);
  • epinephrine (Epi-Pen, Ana-Guard, Bronkaid Mist, Primatene Mist Inhaler, others);
  • norepinephrine (Levophed Bitartrate);
  • dopamine (Intropin);
  • dobutamine (Dobutrex);
  • methyldopa (Aldomet);
  • isoetherine (Bronkosol, Bronkometer);
  • bitolterol (Tornalate)
  • probenecid (Benemid);
  • cholestyramine (Questran, Prevalite, Locholest);
  • erythromycin (Ery-Tab, E-Mycin, Eryc, PCE Dispertab, E.E.S., and others);
  • rifampin (Rimactane, Rifadin); or
  • ampicillin (Principen, Totacillin, Omnipen, and others).

You may not be able to take entacapone, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Entacapone may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Drugs other than those listed here may also interact with entacapone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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