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x 13

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336

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53 A

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23.75’’ (603,3 mm)

1.875’’ (47,6 mm)

1.0’

’ (2

5,4

mm

)

13.2

5’’

(336

,6 m

m)

FRONTTEXT AREA

Revised by: Dan SmithDate: 11/14/13

PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER INJURY IF TASMAR IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY BE CONSIDERED FOR RETREATMENT.

LB0090-01 Rev. 11/13

LB0090-01 Rev. 11/13

LB0090-01 Rev. 11/13

LB0090-01 Rev. 11/13

LB0090-01.indd 1 2013/12/10 9:53 AM

BACKTEXT AREA

23.75” (603,3 mm)

1,875’’ 47,6 mm

1.0”

(2

5,4

mm

)

13.2

5’’

(336

,6 m

m)

Revised by: Dan SmithDate: 11/05/13

Geriatric Use: Parkinson's disease is primarily an affliction of the elderly. Consequently, the mean age of patients in tolcapone clinical trials was 60 to 65 years. To investigate safety as it relates to advanc-ing age, three subgroups were identified: less than 65 years, 65 to 75 years, and greater than 75 years. 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).

LB0090-01 Rev. 11/13

LB0090-01.indd 2 2013/12/10 9:53 AM