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Tolcapone Pregnancy and Breastfeeding Warnings

Tolcapone is also known as: Tasmar

Tolcapone Pregnancy Warnings

Tolcapone has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of an increased rate of abortion, decreased litter size, and impaired growth and learning performance. Evidence of maternal toxicity including death has been reported. Also in animal studies, concomitant use of levodopa/carbidopa with tolcapone produced an increased incidence of fetal malformations (primarily external and skeletal digit defects) when compared to levodopa/carbidopa alone. Decreased fetal body weights were also reported. There are no controlled data in human pregnancy. Tolcapone is only recommended for use during pregnancy when benefit outweighs risk.

Tolcapone Breastfeeding Warnings

There are no data on the excretion of tolcapone into human milk. The manufacturer recommends that caution be used when administering tolcapone to nursing women.

The manufacturer has reported that tolcapone was excreted into maternal rat milk.

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