Selegiline

The Basics

What is Selegiline?

used to treat mental depression in adults

Brand names for Selegiline

Emsam

How Selegiline is classified

Antiparkinson Agents, Monoamine Oxidase Inhibitors, Neuroprotective Agents

Selegiline During Pregnancy

Selegiline pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Selegiline while pregnant

In an embryofetal development study in rats, dams were treated with transdermal selegiline during theperiod of organogenesis at doses of 10, 30, and 75 mg/kg/day (8, 24, and 60 times the maximumrecommended human dose [MRHD] of EMSAM [12 mg/24 hours] on a mg/m2 basis). At the highestdose there was a decrease in fetal weight and slight increases in malformations, delayed ossification(also seen at the mid dose), and embryofetal post-implantation lethality. Concentrations of selegilineand its metabolites in fetal plasma were generally similar to those in maternal plasma. In an oral embryofetal development study in rats, a decrease in fetal weight occurred at the highest dose tested(36 mg/kg; no-effect dose 12 mg/kg); no increase in malformations was seen.In an embryofetal development study in rabbits, dams were treated with transdermal selegiline duringthe period of organogenesis at doses of 2.5, 10, and 40 mg/kg/day (4, 16, and 64 times the MRHD on amg/m2 basis). A slight increase in visceral malformations was seen at the high dose. In an oralembryofetal development study in rabbits, increases in total resorptions and post-implantation loss, anda decrease in the number of live fetuses per dam, occurred at the highest dose tested (50 mg/kg; noeffect dose 25 mg/kg).In a prenatal and postnatal development study in rats, dams were treated with transdermal selegiline atdoses of 10, 30, and 75 mg/kg/day (8, 24, and 60 times the MRHD on a mg/m2 basis) on days 6 – 21 ofgestation and days 1 – 21 of the lactation period. An increase in post-implantation loss was seen at themid and high doses, and an increase in stillborn pups was seen at the high dose. Decreases in pupweight (throughout lactation and post-weaning periods) and survival (throughout lactation period),retarded pup physical development, and pup epididymal and testicular hypoplasia, were seen at the midand high doses. Retarded neurobehavioral and sexual development was seen at all doses. Adverseeffects on pup reproductive performance, as evidenced by decreases in implantations and litter size,were seen at the high dose. These findings suggest persistent effects on the offspring of treated dams.A no-effect dose was not established for developmental toxicity. In this study, concentrations ofselegiline and its metabolites in milk were ~ 15 and 5 times, respectively, the concentrations in plasma,indicating that the pups were directly dosed during the lactation period.There are no adequate and well-controlled studies in pregnant women. EMSAM should be used duringpregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Selegiline While Breastfeeding

What are recommendations for lactation if you're taking Selegiline?

A minimal amount of clinical use of selegiline during breastfeeding has been reported. Although no adverse reactions have been reported in the breastfed infants, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. The manufacturer of the selegiline transdermal patch recommends that breastfeeding is not recommended during treatment and for 5 days after the final dose.

Maternal / infant drug levels

A minimal amount of clinical use of selegiline during breastfeeding has been reported. Although no adverse reactions have been reported in the breastfed infants, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. The manufacturer of the selegiline transdermal patch recommends that breastfeeding is not recommended during treatment and for 5 days after the final dose.

Possible effects of Selegiline on milk supply

Selegiline can decrease serum prolactin in women with migraine,[3] and in those taking neuroleptic drugs.[4][5] The clinical relevance of these findings in nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Selegiline

None listed