Cholinesterase Inhibitor (CNS Agent)
PREGNANCY RECOMMENDATION: No Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Potential Toxicity
PREGNANCY SUMMARY
No reports describing the use of galantamine in human pregnancy have been located. Because of its indication, such reports should be rare. Moreover, the animal data suggest that the risk to the embryo and/or fetus is low. Therefore, inadvertent exposure to galantamine during pregnancy should not be a reason for pregnancy termination.
FETAL RISK SUMMARY
Galantamine is a reversible cholinesterase inhibitor that is indicated for the treatment of mild-to-moderate dementia of the Alzheimer’s type. The metabolites are apparently inactive. Plasma protein binding is low (18%) and the plasma elimination half-life is about 7 hours (1).
Reproduction studies have been conducted in rats and rabbits. In rats, a dose three times the maximum recommended human dose based on BSA (MRHD) given for 14 days before mating through organogenesis caused a slight increase in skeletal variations. No major malformations were observed with a dose seven times the MRHD. When rats were given doses three and seven times the MRHD from the beginning of organogenesis through postpartum day 21, pup weights were decreased. However, no other adverse effects on postnatal development were observed. The above doses also caused slight maternal toxicity. No impairment of fertility was observed in female rats given doses up to seven times the MRHD for 14 days or in male rats for 60 days before mating. In rabbits, doses up to 32 times the MRHD during organogenesis revealed no evidence of teratogenicity (1).
It is not known if galantamine crosses the human placenta. The molecular weight (about 287 for the free base), low plasma protein binding, and the moderately long plasma elimination half-life suggest that the drug will cross to the embryo and/or fetus.
BREASTFEEDING SUMMARY
No reports describing the use of galantamine during human lactation have been located. Because of its indication, such reports should be rare. The molecular weight (about 287 for the free base), its low plasma protein binding (18%), and moderately long plasma elimination half-life (about 7 hours) suggest that galantamine will be excreted into breast milk. The effects of this exposure on a nursing infant are unknown.
Reference
1.Product information. Razadyne. Janssen Pharmaceutica Products, 2004.