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

You should not use this medication if you are allergic to tolcapone, if you have liver disease, or if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Serious or fatal side effects on the liver have occurred in some people taking this medication. You may be required to read and sign a Patient Consent form before you get a prescription for tolcapone.

Call your doctor at once if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage.

Avoid drinking alcohol, which can increase some of the side effects of tolcapone.

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

Do not stop using tolcapone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using tolcapone.

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 tolcapone.

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 tolcapone?

When used with carbidopa and levodopa (Atamet, Parcopa, Sinemet), tolcapone increases levels of levodopa in the body.

Tolcapone is used together with carbidopa and levodopa to treat symptoms of Parkinson’s disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

This medication is usually reserved for use only in people who have used carbidopa and levodopa without success in treating their Parkinson’s disease.

Tolcapone is usually given to people who are already taking carbidopa and levodopa but have not had successful treatment of symptoms.

Tolcapone may also be used for other purposes not listed in this medication guide.

Precautions

You should not use this medication if you are allergic to tolcapone, or if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Serious or fatal side effects on the liver have occurred in some people taking this medication. You may be required to read and sign a Patient Consent form before you get a prescription for tolcapone.

Do not take this medication if you are allergic to tolcapone, or if you have:

  • liver disease; or
  • if you have ever had muscle damage or fever and confusion caused by a medication.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking tolcapone, tell your doctor if you have:

  • low blood pressure; or
  • kidney disease.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking tolcapone. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking tolcapone.

FDA pregnancy category C. It is not known whether tolcapone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether tolcapone passes into breast milk or if it could harm a nursing baby. Do not take tolcapone without telling your doctor if you are breast-feeding a baby.

Tolcapone may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you experience hallucinations.

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

Tolcapone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol, which can increase some of the side effects of tolcapone.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, and dizziness.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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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 any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out;
  • fever, stiff muscles, confusion, and sweating (especially when you first start taking tolcapone);
  • hallucinations;
  • tremors (uncontrolled shaking);
  • tight feeling in your chest, trouble breathing;
  • pain or burning when you urinate;
  • severe or ongoing diarrhea; or
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • diarrhea or constipation;
  • dry mouth;
  • headache, tired feeling;
  • unusual skin changes;
  • dizziness, drowsiness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • sleep problems (insomnia), dreaming more than usual; or
  • agitation or anxiety.

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. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

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

Before taking tolcapone, tell your doctor if you are using any of the following drugs:

  • apomorphine (Apokyn);
  • a blood thinner such as warfarin (Coumadin);
  • desipramine (Norpramin);
  • dobutamine (Dobutrex);
  • epinephrine (Epi-Pen, and others);
  • isoproterenol (Isuprel, Medihaler-Iso); or
  • methyldopa (Aldomet).

This list is not complete and there may be other drugs that can interact with tolcapone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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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