What is the most important information I should know about tolcapone?
You should not use this medicine if you have liver disease, if you have ever had liver problems caused by tolcapone, or if you have ever had muscle damage or fever and confusion caused by using any medication.
Do not use tolcapone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Tolcapone can cause liver failure. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using tolcapone.
Call your doctor at once if you have nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Your liver function will need to be checked often: Every 2 to 4 weeks for the first 6 months of treatment, and then as often as your doctor recommends.
In rare cases, tolcapone can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
What is tolcapone?
Tolcapone is used together with other medicines (carbidopa and levodopa) to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Tolcapone increases levels of levodopa in the body.
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.
What should I discuss with my healthcare provider before taking tolcapone?
You should not use this medicine if you are allergic to tolcapone, or if you have:
- liver disease;
- a history of liver problems caused by tolcapone; or
- a history of muscle damage or fever and confusion caused by using any medication.
Do not use tolcapone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Tolcapone can cause liver failure. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using tolcapone. You may be required to read and sign a Patient Consent form before you get a prescription for tolcapone.
To make sure tolcapone is safe for you, tell your doctor if you have:
- kidney disease; or
- low blood pressure.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if this occurs.
Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
FDA pregnancy category C. It is not known whether tolcapone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether tolcapone passes into breast milk or if it could harm a nursing baby. Tell 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 have hallucinations.
How should I take tolcapone?
Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not take tolcapone as your only Parkinson's medication. Tolcapone must be used in combination with carbidopa and levodopa.
Tolcapone is usually taken three times a day. The first dose is taken with your first daily dose of carbidopa and levodopa. The second and third doses of tolcapone are taken 6 and 12 hours later.
Tolcapone may be taken with or without food.
Call your doctor if your symptoms do not improve after 3 weeks of treatment.
Tolcapone may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.
Your liver function will need to be checked often: Every 2 to 4 weeks for the first 6 months of treatment, and then as often as your doctor recommends.
Do not stop using tolcapone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using tolcapone.
Store at room temperature in a tightly closed container, away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking tolcapone?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be 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.
Drinking alcohol can increase certain side effects of tolcapone.
What are the possible side effects of tolcapone?
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:
- nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- confusion, hallucinations, unusual thoughts or behavior;
- severe or ongoing diarrhea;
- worsening tremors, stiffness, or muscle spasms; or
- a light-headed feeling, like you might pass out.
Common side effects may include:
- drowsiness;
- mild diarrhea;
- sleep problems; or
- increased sweating.
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.
What other drugs will affect tolcapone?
Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking tolcapone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with tolcapone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about tolcapone.
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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