tolcapone (Oral route)

TOLE-ka-pone

Oral route(Tablet)

Tolcapone use has been associated with a risk of potentially fatal, acute fulminant liver failure. Avoid use in patients with liver disease and monitor liver enzymes before starting treatment with tolcapone and periodically during therapy. Discontinue therapy if liver dysfunction develops or if a patient fails to show substantial clinical benefit within 3 weeks of initiation of treatment. Use caution in patients with severe baseline dyskinesia or dystonia .

Commonly used brand name(s)

In the U.S.

  • Tasmar

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Catechol-O-Methyltransferase Inhibitor

Uses For tolcapone

Tolcapone is used in combination with levodopa and carbidopa for the treatment of the symptoms of Parkinson's disease.

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tolcapone is available only with your doctor's prescription.

Before Using tolcapone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tolcapone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tolcapone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on tolcapone have been done only in adult patients. There is no identified potential use of tolcapone in children.

Geriatric

The risk of hallucinations (seeing, hearing, or feeling things that are not there) may be increased in patients older than 75 years of age.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tolcapone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tolcapone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of tolcapone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hallucinations (seeing, hearing, or feeling things that are not there)—Condition may become worse.
  • High fever and confusion or
  • Muscle injury, aches, cramps—You should not take tolcapone.
  • Kidney problems, severe—Elimination of tolcapone may be decreased, which increases the risk of unwanted effects.
  • Liver problems or
  • Liver tests higher than normal—tolcapone can increase chances of serious liver problems. You should not start taking tolcapone if you have these problems.
  • Low blood pressure or
  • Orthostatic or postural low blood pressure (dizziness or lightheadedness when getting up suddenly from a sitting or lying position)—Condition may become worse.

Proper Use of tolcapone

Take tolcapone only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

It is important that you and your doctor discuss the risks of tolcapone and that you read and sign a written informed consent before you begin taking tolcapone.

Dosing

The dose of tolcapone 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 tolcapone. 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 form (tablets):
    • For Parkinson's disease:
      • Adults—100 milligrams (mg) three times a day, taken in addition to levodopa and carbidopa.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of tolcapone, 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.

Precautions While Using tolcapone

It is important that your doctor check your progress at regular visits. Tolcapone may have serious effects on your liver. You must have regular blood tests done to make sure tolcapone is not affecting your liver.

Because tolcapone may have serious effects on your liver, you should watch for any signs of these effects. Signs include dark urine; itching; light-colored stools; loss of appetite; nausea (continuing); tenderness in upper right part of abdomen; unusual drowsiness, dullness, or feeling sluggish; unusual tiredness or weakness; or yellow eyes or skin. If you notice any of these signs, contact your doctor.

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

Tolcapone may cause dizziness or lightheadedness, drowsiness, weakness, or trouble in thinking or concentrating. Make sure you know how you react to tolcapone before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think clearly.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.

Hallucinations (seeing, hearing, or feeling things that are not there) may occur in some patients. This is more common in elderly patients.

You may experience nausea, especially when you first begin taking tolcapone.

Tolcapone causes the urine to turn bright yellow. This is to be expected while you are taking it. This effect is harmless and will go away after you stop taking the medicine.

tolcapone 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:

Incidence not known
  • Dark urine
  • itching
  • light-colored stools
  • loss of appetite
  • nausea (continuing)
  • tenderness in upper right part of abdomen
  • unusual drowsiness, dullness, or feeling sluggish
  • unusual tiredness or weakness
  • yellow eyes or skin

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Abdominal pain
  • cough
  • diarrhea
  • dizziness
  • dizziness or lightheadedness when getting up from a lying or sitting position
  • drowsiness
  • fainting
  • fever
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • headache
  • nasal congestion (stuffy nose)
  • nausea
  • runny nose
  • sneezing
  • sore throat
  • trouble in sleeping
  • twitching, twisting, or other unusual body movements
  • vomiting
Less common
  • Absence of or decrease in body movement
  • blood in urine
  • chest pain
  • chills
  • confusion
  • falling
  • general feeling of discomfort or illness
  • hyperactivity
  • loss of balance control
  • muscle pain
  • troubled breathing
Rare
  • Agitation
  • bloody or cloudy urine
  • burning of feet
  • burning, prickling, or tingling sensations
  • chest discomfort
  • difficult or painful urination
  • difficulty in thinking or concentrating
  • frequent urge to urinate
  • irritability
  • joint pain, redness, or swelling
  • low blood pressure
  • muscle cramps
  • neck pain
  • stiffness

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
  • Constipation
  • dryness of mouth
  • excessive dreaming
  • increased sweating
Less common
  • Bleeding
  • difficulty in sleeping
  • excessive muscle tone
  • fever
  • heartburn
  • gas
  • muscle stiffness
  • muscle tension or tightness
  • trouble in holding or releasing urine

After you stop using tolcapone, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Confusion
  • fever
  • muscle rigidity

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.

See also: Side effects (in more detail)

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