A dopaminergic antiparkinsonism agent - It is used in combination with levodopa-carbidopa therapy to... more
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.
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your the advice of your doctor or health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups. You will need to have important blood work done while you are taking this medicine. Tell your doctor if your symptoms do not get better or if they get worse.
You may get dizzy or have difficulty controlling your movements. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase possible dizziness. Avoid alcoholic drinks.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
There have been reports of increased sexual urges or other strong urges such as gambling while taking some medicines for Parkinson's disease. If you experience any of these urges while taking this medicine, you should report it to your health care provider as soon as possible.
You should check your skin often for changes to moles and new growths while taking this medicine. Call your doctor if you notice any of these changes.
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