Memotin Use In Pregnancy & Lactation

Fertility: No impairment of fertility or reproductive performance was seen in rats administered up to 18 mg per kg per day (9 times the human MRHD on a mg per m² basis) orally from 14 days prior to mating through gestation and lactation in females, or for up to 60 days prior to mating in males.
Pregnancy: Category B. There are no adequate and well-controlled studies of memantine in pregnant woman. Use memantine during pregnancy only if the potential benefit justifies the potential risk to the fetus. Memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg per kg per day in rats and 30 mg per kg per day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose (MRHD) on a mg per m² basis). Slight maternal toxicity, decreased pup weight, and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg per kg per day in a study in which rats were given oral memantine beginning pre-mating and continuing through the postpartum period. Slight maternal toxicity and decreased pup weights were also seen at this dose in a study in which rats were treated from day 15 of gestation through the postpartum period. The no-effect dose for these effects was 6 mg per kg, which is 3 times the MRHD on a mg per m² basis.
Lactation: It is not known whether memantine is excreted in human breast milk. Due to the large volume of distribution, it is unlikely that memantine would transfer to any measurable extent. Because many drugs are excreted in human milk, exercise caution when memantine is administered to a breast-feeding woman.