Data from 2 mothers indicate that levels of ezetimibe and its active metabolite appear in very low amounts in milk and serum levels in infants predicted by a pharmacokinetic model are considerably lower than in adults. Ezetimibe appears to be acceptable during breastfeeding. Ezetimibe in combination with a statin (e.g., atorvastatin, simvastatin) should be avoided in nursing mothers.
Drug Levels
Maternal Levels. Two nursing mothers taking ezetimibe 10 mg daily donated a total of 15 milk samples for analysis of ezetimibe and ezetimibe glucuronide. In one mother, the highest drug concentrations were found in hindmilk at 2.08 hours after a dose. The ezetimibe concentration was 0.95 mcg/L and the glucuronide concentration was 1.39 mcg/L. In the second mother, the highest ezetimibe concentration of 0.98 mcg/L occurred 5.22 hours after a dose between feedings and the highest ezetimibe glucuronide concentration of 2.65 mcg/L occurred 8.47 hours after a dose just after feeding. These values result in a total ezetimibe plus ezetimibe glucuronide relative infant dosages of about 0.16% and 0.25%, respectively. A computer model of ezetimibe during nursing was consistent with the observed levels and indicated that predicted serum levels in infants were considerably lower than in adults.[1]
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.
Yeung CHT, Autmizguine J, Dalvi P, et al. Maternal ezetimibe concentrations measured in breast milk and its use in breastfeeding infant exposure predictions. Clin Pharmacokinet 2024;63:317-32. [PubMed: 38278872]
Substance Identification
Substance Name
Ezetimibe
CAS Registry Number
163222-33-1
Drug Class
Breast Feeding
Lactation
Milk, Human
Anticholesteremic Agents
Antilipemic Agents
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