Generic Name: tolcapone (TOL-ka-pone)
Brand Name: Tasmar
Severe and possibly fatal liver problems may occur in patients who take tolcapone. Tolcapone should only be used in certain patients who cannot take or have not responded to other treatments. Patients who do not show an improvement in their symptoms after taking tolcapone for at least 3 weeks should stop taking it due to possible risk of liver injury. Patients who have liver disease or have had 2 abnormal liver function tests should not start taking tolcapone. Liver function tests will be performed before and during treatment to monitor side effects. However, these tests may not decrease the risk of developing serious liver problems. Make sure to keep all doctor and lab appointments. Contact your doctor at once if you develop dark urine, loss of appetite, pale stools, right-sided stomach pain, severe or persistent nausea or tiredness, sluggishness, or yellowing of the skin or eyes. Patients who develop liver problems while taking tolcapone should not take tolcapone again.
Patients who have a history of severe uncontrolled muscle movement (eg, jerking, twitching) should use tolcapone with extreme caution.
Tolcapone is used for:
Treating Parkinson disease. It is used along with levodopa/carbidopa. It is only used in patients who cannot take or have not responded to other medications.
Tolcapone is a catechol-O-methyltransferase (COMT) inhibitor. It works by prolonging the anti-Parkinson effect action of levodopa.
Do NOT use tolcapone if:
- you are allergic to any ingredient in tolcapone
- you have liver disease or have had 2 abnormal liver function tests
- you had to stop taking tolcapone before because of liver problems
- you have a history of certain muscle problems (rhabdomyolysis) or fever and confusion that may have been caused by tolcapone
- you are taking a nonselective monoamine oxidase inhibitor (MAOI) (eg, phenelzine)
Contact your doctor or health care provider right away if any of these apply to you.
Before using tolcapone:
Some medical conditions may interact with tolcapone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning 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, foods, or other substances
- if you have a history of kidney problems, liver problems (eg, cirrhosis), abnormal liver function tests, mental or mood problems (eg, depression), or sleep problems (eg, daytime sleepiness)
- if you have a history of severe, uncontrolled muscle movements (eg, uncontrolled jerking, twitching) or a certain severe muscle problem (rhabdomyolysis)
- if you experience dizziness or light-headedness when you stand up
Some MEDICINES MAY INTERACT with tolcapone. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Warfarin because the risk of bleeding may be increased
- Desipramine or nonselective MAOIs (eg, phenelzine) because they may increase the risk of tolcapone's side effects
- Apomorphine, dobutamine, isoproterenol, levodopa, methyldopa, or a sympathomimetic (eg, albuterol, pseudoephedrine) because the risk of their side effects may be increased by tolcapone
This may not be a complete list of all interactions that may occur. Ask your health care provider if tolcapone 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 tolcapone:
Use tolcapone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take tolcapone by mouth with or without food.
- Do not suddenly stop taking tolcapone. You may have an increased risk of Parkinson disease symptoms, fever, confusion, or muscle rigidity. If you need to stop tolcapone or add a new medicine, your doctor will gradually lower your dose.
- If you miss a dose of tolcapone, 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 tolcapone.
Important safety information:
- You must discuss the benefits and risks of tolcapone with your doctor and sign a patient acknowledgment form before you begin treatment with tolcapone.
- Tolcapone may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use tolcapone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using tolcapone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Tolcapone may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Some patients who take tolcapone have reported suddenly falling asleep while performing daily activities (eg, driving, eating, talking). Some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Some of these events have been reported as late as 1 year after tolcapone was started. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while using tolcapone.
- If your symptoms do not get better within 3 weeks or if they get worse, check with your doctor.
- Some patients who take tolcapone may develop certain muscle movements that they cannot control. Tell your doctor at once if you have new or worsening muscle problems with your arms, legs, or your face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while you take tolcapone.
- Tolcapone may cause nausea or diarrhea. Nausea may be more likely when you first start taking tolcapone. If nausea or diarrhea occurs, discuss with your doctor ways to lessen the effects.
- Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using tolcapone. Tell your doctor right away if you notice such effects.
- Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if tolcapone also increases the risk of melanoma. You may need to have skin exams while you are using tolcapone. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.
- Use tolcapone with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations.
- Lab tests, including liver function tests, may be performed while you use tolcapone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Tolcapone is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using tolcapone while you are pregnant. It is not known if tolcapone is found in breast milk. If you are or will be breast-feeding while you use tolcapone, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of tolcapone:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; light-headedness when sitting up or standing; mild loss of appetite; nausea; sleepiness; stomach upset; stuffy nose; trouble sleeping; unusual or excessive dreams; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; blood in the urine; chest pain; confusion; fainting; falling; fever; hallucinations; muscle pain (with or without fever or confusion); new or worsening behavior, mental, or mood changes (eg, agitation, depression, paranoia); new or worsening uncontrolled muscle movements of the arms, legs, or of the tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements); rigid muscles; severe or persistent diarrhea; severe or persistent dizziness, drowsiness, or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, right-sided stomach pain, severe or persistent nausea or tiredness, sluggishness, yellowing of the skin or eyes).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; nausea; vomiting.Proper storage of tolcapone:
Store tolcapone at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tolcapone out of the reach of children and away from pets.
- If you have any questions about tolcapone, please talk with your doctor, pharmacist, or other health care provider.
- Tolcapone 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take tolcapone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tolcapone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tolcapone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using tolcapone.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.