Tolcapone

Tolcapone is used along with other medicines (carbidopa and levodopa) to help treat symptoms of Parkinson's disease, including stiffness, tremors, muscle spasms, and poor muscle control. Tolcapone raises the levels of levodopa in the body.

Tolcapone is typically given to people who are already taking carbidopa and levodopa but have not found relief from their symptoms.

Tolcapone may also be used for reasons not mentioned in this medication guide.

Your doctor will do blood tests to check that you do not have any conditions that would make it unsafe for you to use tolcapone.

Follow all the instructions on your prescription label. Your doctor may change your dose from time to time. Do not take this medicine in larger or smaller amounts or for longer than what is recommended.

Do not use tolcapone as your only Parkinson's medication. Tolcapone must be taken together with carbidopa and levodopa.

Tolcapone is usually taken three times a day. The first dose should be taken with your first daily dose of carbidopa and levodopa. The second and third doses of tolcapone should be taken 6 and 12 hours later.

Follow your doctor's dosing instructions very carefully.

Tolcapone can be taken with or without food.

Tolcapone may cause you to fall asleep during normal daytime activities like working, talking, eating, or driving. You may fall asleep suddenly, even if you feel alert. Tell your doctor if you have any issues with daytime sleepiness or drowsiness.

Your liver function will need to be checked frequently: Every 2 to 4 weeks for the first 6 months of treatment, and then as often as your doctor advises.

Call your doctor if your symptoms do not improve after 3 weeks of treatment.

Do not stop using tolcapone suddenly, as this could lead to 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.

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 used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Tolcapone can cause liver failure. Call your doctor at once if you have unusual tiredness, 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.

You should not use tolcapone if you are allergic to it, 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 used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tolcapone can cause liver failure. You may need to read and sign a Patient Consent form before getting a prescription for tolcapone.

To make sure tolcapone is safe for you, tell your doctor if you have ever had:

• liver disease;
• kidney disease; or
• low blood pressure.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether tolcapone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether tolcapone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, tolcapone can cause a condition that breaks down skeletal muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• severe or ongoing diarrhea;
• confusion, hallucinations (hearing or seeing something that is not there), unusual thoughts or behavior;
• worsening tremors, stiffness, or muscle spasms; or
• liver problems—nausea, loss of appetite, right-sided upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Certain side effects may be more likely in older adults.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking tolcapone. Talk with your doctor if this occurs.

Common side effects of tolcapone may include:

• dizziness, drowsiness;
• nausea, diarrhea, loss of appetite;
• sleep problems, increased dreaming; or
• muscle cramps.

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.

Usual Adult Dose for Parkinson's Disease:

Initial dose: 100 mg orally 3 times a day-Dose should be increased to 200 mg orally 3 times a day only if the anticipated incremental clinical benefit is justifiedMaximum dose: 600 mg/day Comments:-Because of the risk of potentially fatal acute fulminant liver failure, this drug should only be used in patients who are experiencing symptom fluctuations and are not responding satisfactorily to, or are not appropriate candidates for, other adjunctive therapies.-For patients who do not demonstrate observable symptomatic benefit within 3 weeks of starting therapy, therapy should be discontinued. -In clinical trials, the first dose of the day was always taken with the first dose of the day of levodopa/carbidopa, and subsequent doses were given 6 and 12 hours later.-In clinical trials, a majority of patients who had levodopa doses greater than 600 mg/day or had moderate or severe dyskinesias prior to starting therapy, required a dose reduction of levodopa; the average dose reduction of levodopa was about 30%. Use: As an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose can cause vomiting and severe dizziness.

This medication may affect your thinking or reactions. Be cautious if you drive or do anything that requires you to be alert.

Avoid standing up too quickly from a sitting or lying position, or you may feel dizzy. Stand up slowly and steady yourself to prevent a fall.

Drinking alcohol with tolcapone can cause side effects.

Taking tolcapone with other medicines that make you sleepy can make this effect stronger. Ask your doctor before taking a sleeping pill, opioid pain medication, 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 your doctor about all the medicines you are currently using and any medicine you begin or stop using.