Memantine Pregnancy and Breastfeeding Warnings
Brand names: Namenda, Namenda XR
Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.
Memantine Pregnancy Warnings
Use is not recommended during pregnancy unless clearly necessary.
AU TGA pregnancy category: B2
US FDA pregnancy category: B
Animal studies have not revealed evidence of teratogenicity up to the highest doses tested (30 times the maximum recommended human dose (MRHD) for the immediate-release [IR] drug and 21 times the MRHD for the extended-release [XR] drug). However, slight maternal toxicity, decreased pup weights, and an increased incidence of non-ossified cervical vertebrae occurred at an oral dose 6 (XR) to 9 (IR) times the MRHD in some animals. Fetal growth reduction was noted in animals at exposure levels identical or slightly higher than at human exposure, but no impairment of fertility or reproductive performance has been observed. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Memantine Breastfeeding Warnings
AU: Use is contradicted in breastfeeding women.
UK, US: Use with caution during breastfeeding.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-It is probable that this drug is excreted into human milk based on its lipophilicity.
-The effects in the nursing infant are unknown.
Animal studies revealed oral administration of this drug during late gestation and lactation were associated with increased post-implantation loss and transiently reduced neonatal bodyweight at estimated systemic exposures 4-fold that of anticipated clinical exposure at the recommended dose.
See also
References for pregnancy information
- Product Information. Namenda (memantine). Forest Pharmaceuticals. 2003.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Namenda XR (memantine). Forest Pharmaceuticals. 2014.
References for breastfeeding information
- Product Information. Namenda (memantine). Forest Pharmaceuticals. 2003.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Namenda XR (memantine). Forest Pharmaceuticals. 2014.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
