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STALEVO (LEVODOPA WITH CARBIDOPA AND ENTACAPONE) TABLETS: PHARMACOKINETICS IN SPECIAL POPULATIONS

Hepatic Impairment

Stalevo (Carbidopa/Levodopa/Entacapone)

While there are no studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment, Stalevo should be administered cautiously to patients with biliary obstruction or hepatic disease since biliary excretion appears to be the major route of excretion of entacapone and hepatic impairment had a significant effect on the pharmacokinetics of entacapone when 200 mg entacapone was administered alone.

Entacapone

Hepatic impairment had a significant effect on the pharmacokinetics of entacapone when 200 mg entacapone was administered alone. A single 200 mg dose of entacapone, without levodopa/dopa decarboxylase inhibitor coadministration, showed approximately two-fold higher AUC and Cmax values in patients with a history of alcoholism and hepatic impairment (n=10) compared to normal subjects (n=10). All patients had biopsy-proven liver cirrhosis caused by alcohol. According to Child-Pugh grading 7 patients with liver disease had mild hepatic impairment and 3 patients had moderate hepatic impairment. As only about 10% of the entacapone dose is excreted in urine, as parent compound and conjugated glucuronide, biliary excretion appears to be the major route of excretion of this drug. Consequently, Stalevo should be administered with care to patients with biliary obstruction or hepatic disease.

Renal Impairment

Stalevo (Carbidopa/Levodopa/Entacapone)

Stalevo should be administered cautiously to patients with severe renal disease. There are no studies on the pharmacokinetics of levodopa and carbidopa in patients with renal impairment.

Entacapone

No important effects of renal function on the pharmacokinetics of entacapone were found. The pharmacokinetics of entacapone have been investigated after a single 200 mg entacapone dose, without levodopa/dopa decarboxylase inhibitor coadministration, in a specific renal impairment study. There were three groups: normal subjects (n=7; creatinine clearance >1.12 mL/sec/1.73 m2), moderate impairment (n=10; creatinine clearance ranging from 0.60-0.89 mL/sec/1.73 m2), and severe impairment (n=7; creatinine clearance ranging from 0.20-0.44 mL/sec/1.73 m2).

Concurrent Diseases

Stalevo (Carbidopa/Levodopa/Entacapone) tablets should be administered cautiously to patients with biliary obstruction, hepatic disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, or endocrine disease.

Elderly

Stalevo tablets have not been studied in Parkinson's disease patients or in healthy volunteers older than 75 years old. In the pharmacokinetics studies conducted in healthy volunteers following single dose of carbidopa/levodopa/entacapone (as Stalevo or as separate carbidopa/levodopa and Comtan tablets):

Levodopa

The AUC of levodopa is significantly (on average 10%-20%) higher in elderly (60-75 years) than younger subjects (45-60 years). There is no significant difference in the Cmax of levodopa between younger (45-60 years) and elderly subjects (60-75 years).

Carbidopa

There is no significant difference in the Cmax and AUC of carbidopa, between younger (45-60 years) and elderly subjects (60-75 years).

Entacapone

The AUC of entacapone is significantly (on average, 15%) higher in elderly (60-75 years) than younger subjects (45-60 years). There is no significant difference in the Cmax of entacapone between younger (45-60 years) and elderly subjects (60-75 years).

Gender

The bioavailability of levodopa is significantly higher in females when given with or without carbidopa and/or entacapone. Following a single dose of carbidopa, levodopa and entacapone together, either as Stalevo or as separate carbidopa/levodopa and Comtan tablets in healthy volunteers (age range 45-74 years):

Levodopa

The plasma exposure (AUC and Cmax) of levodopa is significantly higher in females than males (on average, 40% for AUC and 30% for Cmax). These differences are primarily explained by body weight. Other published literature showed significant gender effect (higher concentrations in females) even after correction for body weight.

Carbidopa

There is no gender difference in the pharmacokinetics of carbidopa.

Entacapone

There is no gender difference in the pharmacokinetics of entacapone.

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