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U.S. Department of Health and Human Services

Safety

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Tasmar (tolcapone) 100 mg Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

May 2013

Summary View

WARNINGS

Patients Falling Asleep During Activities of Daily Living and Somnolence
  • new section added - standard class language - see PI

PRECAUTIONS

Hallucinations/Psychotic Like Behavior
  • new section added - standard class language - see PI
Impulse Control/Compulsive Behaviors
  • new section added - standard class language - see PI
Geriatric Use
  • section added:Parkinson’s disease is primarily an affliction of ..... There were generally no consistent age-related trends in safety parameters. However, patients greater than 75 years of age may be more likely to develop hallucinations than patients less than 75 years of age, while patients over 75 may be less likely to develop dystonia (see PRECAUTIONS: Hallucinations/Psychotic Like Behavior). In tolcapone clinical trials, measures of therapeutic efficacy (effects on “Off” time, levodopa dose, and effects on Activities of Daily Living) were not affected by age (see CLINICAL PHARMACOLOGY: Clinical studies). Tolcapone pharmacokinetics have not been found to be affected by age (see CLINICAL PHARMACOLOGY: Special Populations).