No published information is available on the clinical use of ganaxolone during breastfeeding. However, a study by the manufacturer indicates that amounts in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants.
Drug Levels
Maternal Levels. The manufacturer reports that a study was conducted in 5 healthy adult lactating women treated with a single 300 mg oral dose of ganaxolone. The calculated maximum relative infant dose for ganaxolone was approximately 0.157 mg/kg daily based on an average milk intake of 150 mL/kg daily, which is less than 1% of the maternal dose, and approximately 0.24% the labeled pediatric dose of 63 mg/kg/day.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Substance Identification
Substance Name
Ganaxolone
CAS Registry Number
38398-32-2
Drug Class
Breast Feeding
Lactation
Milk, Human
Anticonvulsants
GABA Agents
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
