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Generic Name: tolcapone

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A dopaminergic antiparkinsonism agent - treats Parkinson's Disease

FDA Alerts

Tolcapone should not be initiated until the clinician has fully explained the risks and the patient (or representative) has provided written informed consent.
Use with caution in patients with severe dystonia or dyskinesia. (See Rhabdomyolysis under Cautions.)

Hepatotoxicity

Risk of potentially fatal, acute fulminant hepatic failure. Incidence may be 10- to 100-fold higher than the background incidence in the general population.
Generally reserve tolcapone therapy for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies (e.g., ergot- and nonergot-derivative dopamine receptor agonists, selegiline).
Do not initiate tolcapone in patients with clinical evidence of active liver disease, ALT or AST concentrations exceeding the ULN, or any other evidence of hepatocellular dysfunction.
Discontinue tolcapone if the patient does not experience symptomatic improvement within 3 weeks of initiating therapy.
Discontinue tolcapone if aminotransferase concentrations exceed the ULN or if clinical manifestations suggest the onset of hepatic failure (e.g., persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, upper right quadrant tenderness).
Advise patients of the need for self-monitoring for signs or symptoms of liver disease.
Patients who develop evidence of hepatocellular injury while receiving tolcapone and in whom such therapy is discontinued for any reason may be at increased risk for hepatic injury if tolcapone is reintroduced. Retreatment with tolcapone ordinarily should not be considered in such patients.
Perform appropriate tests to exclude hepatic disease prior to initiation of therapy and monitor patients receiving tolcapone for evidence of emergent liver injury.
Evaluate serum AST and ALT at baseline, every 2 weeks during the first year of therapy, every 4 weeks during the next 6 months of therapy, and every 8 weeks thereafter. If dosage is increased to 200 mg 3 times daily, determine serum AST and ALT prior to increasing the dosage and then at the same frequency as that recommended when therapy is initiated.
Not known whether baseline and periodic monitoring of liver enzymes will prevent the occurrence of fulminant tolcapone-induced hepatic failure; however, frequent laboratory monitoring for evidence of hepatocellular injury is considered essential. Early detection of drug-induced hepatic injury along with immediate discontinuance of the suspect drug is believed to enhance the likelihood for recovery. Baseline monitoring is recommended, since patients with preexisting liver disease may be more vulnerable to hepatotoxins.

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(TOL ca pone)

What is the most important information I should know about tolcapone?

Do not use tolcapone if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take tolcapone before the MAO inhibitor has cleared from your body.

Serious or fatal side effects on the liver have occurred in some people taking this medication. You may be required to read and sign a Patient Consent form before you get a prescription for tolcapone.

Call your doctor at once if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Avoid drinking alcohol, which can increase some of the side effects of tolcapone.

Avoid using drugs that make you sleepy (such as cold medicine, pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). These medicines may increase drowsiness and dizziness caused by tolcapone.

Do not stop using tolcapone without first talking to your doctor. You may need to use less and less before you stop the medication completely. Tolcapone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Dizziness may be more likely to occur when you rise from a sitting or lying position. Get up slowly to keep from falling.

What is tolcapone?

Tolcapone prevents the breakdown of a chemical in your brain called dopamine (DO pa meen). It also helps other medicines work better in raising the levels of dopamine in your body. Low levels of dopamine are associated with Parkinson's disease.

Tolcapone is used together with other medicines to treat symptoms of Parkinson's disease, such as muscle stiffness, tremors, muscle spasms, and poor muscle control. Tolcapone is used only in combination with carbidopa and levodopa. It is not effective if it is used alone.

This medication is usually reserved for use only in people who have used carbidopa and levodopa without success in treating their Parkinson's disease.

Tolcapone may also be used for purposes other than those listed in the medication guide.

What should I discuss with my healthcare provider before taking tolcapone?

Do not take this medication if you are allergic to tolcapone, or if you have:

liver disease; or
if you have ever had muscle damage or fever and confusion caused by a medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether tolcapone passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

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