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tolcapone Images

Generic Name: tolcapone

Brand Names: Tasmar

There is an FDA Alert for this drug. Click here to view it.

  • 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.)

  • 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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