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

Pregnancy

Stalevo (Carbidopa plus Levodopa and Entacapone) has pregnancy category C.

Carbidopa-levodopa caused both visceral and skeletal malformations in rabbits at all doses and ratios of carbidopa-levodopa tested, which ranged from 10 times/5 times the maximum recommended human dose of carbidopa-levodopa to 20 times/10 times the maximum recommended human dose of carbidopa-levodopa. There was a decrease in the number of live pups delivered by rats receiving approximately two times the maximum recommended human dose of carbidopa and approximately five times the maximum recommended human dose of levodopa during organogenesis. No teratogenic effects were observed in mice receiving up to 20 times the maximum recommended human dose of carbidopa-levodopa.

It has been reported from individual cases that levodopa crosses the human placental barrier, enters the fetus, and is metabolized. Carbidopa concentrations in fetal tissue appeared to be minimal.

In embryo-fetal development studies, entacapone was administered to pregnant animals throughout organogenesis at doses of up to 1000 mg/kg/day in rats and 300 mg/kg/day in rabbits. Increased incidences of fetal variations were evident in litters from rats treated with the highest dose, in the absence of overt signs of maternal toxicity. The maternal plasma drug exposure (AUC) associated with this dose was approximately 34 times the estimated plasma exposure in humans receiving the maximum recommended daily dose (MRDD) of 1600 mg. Increased frequencies of abortions and late/total resorptions and decreased fetal weights were observed in the litters of rabbits treated with maternotoxic doses of 100 mg/kg/day (plasma AUCs 0.4 times those in humans receiving the MRDD) or greater.

There was no evidence of teratogenicity in these studies.

However, when entacapone was administered to female rats prior to mating and during early gestation, an increased incidence of fetal eye anomalies (macrophthalmia, microphthalmia, anophthalmia) was observed in the litters of dams treated with doses of 160 mg/kg/day (plasma AUCs seven times those in humans receiving the MRDD) or greater, in the absence of maternotoxicity. Administration of up to 700 mg/kg/day (plasma AUCs 28 times those in humans receiving the MRDD) to female rats during the latter part of gestation and throughout lactation, produced no evidence of developmental impairment in the offspring.

There is no experience from clinical studies regarding the use of Stalevo (Carbidopa plus Levodopa and Entacapone) tablets in pregnant women. Therefore, Stalevo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Women

In animal studies, carbidopa and entacapone were excreted into maternal rat milk. It is not known whether entacapone or carbidopa-levodopa are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Stalevo is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Stalevo in pediatric patients have not been established.

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