Tolcapone (Oral route)
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 .
Uses of This Medicine:
Tolcapone is used in combination with levodopa and carbidopa for the treatment of the symptoms of Parkinson's disease.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Studies on this medicine have been done only in adult patients. There is no identified potential use of tolcapone in children.
The risk of hallucinations (seeing, hearing, or feeling things that are not there) may be increased in patients older than 75 years of age.
|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.|
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.
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 this medicine, 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 this medicine 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.
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 this medicine. 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—This medicine can increase chances of serious liver problems. You should not start taking this medicine 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 This Medicine:
Take this medicine 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 this medicine and that you read and sign a written informed consent before you begin taking this medicine.
The dose of this medicine 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 this medicine. 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.
- For Parkinson's disease:
If you miss a dose of this medicine, 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.
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 This Medicine:
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 this medicine 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 this medicine 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 this medicine.
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.
Side Effects of This Medicine:
- Incidence not known
- Dark urine
- 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
- More common
- Abdominal pain
- dizziness or lightheadedness when getting up from a lying or sitting position
- hallucinations (seeing, hearing, or feeling things that are not there)
- nasal congestion (stuffy nose)
- runny nose
- sore throat
- trouble in sleeping
- twitching, twisting, or other unusual body movements
- Less common
- Absence of or decrease in body movement
- blood in urine
- chest pain
- general feeling of discomfort or illness
- loss of balance control
- muscle pain
- troubled breathing
- 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
- joint pain, redness, or swelling
- low blood pressure
- muscle cramps
- neck pain
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:
Check with your doctor as soon as possible if any of the following side effects occur:
- More common
- dryness of mouth
- excessive dreaming
- increased sweating
- Less common
- difficulty in sleeping
- excessive muscle tone
- muscle stiffness
- muscle tension or tightness
- trouble in holding or releasing urine
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:
- muscle rigidity
After you stop using this medicine, 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:
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.
Last Updated: 11/4/2014