Nitazoxanide use while Breastfeeding

Summary of Use during Lactation

Limited information indicates that a maternal dose of 500 mg of nitazoxanide produces low levels of an active metabolite, tizoxanide, in breastmilk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. But until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

After oral administration, nitazoxanide is not found in the bloodstream, but is rapidly converted to the active metabolites, tizoxanide and tizoxanide glucuronide, which are detectable in plasma.

Maternal Levels. A volunteer lactating mother took a single 500 mg oral dose of nitazoxanide as a commercial suspension (Nitazode, Al Andalous Medical Co., Cairo, Egypt). The concentration of the active metabolite, tizoxanide, was 1.4 mg/L at 6 hours after the dose. Tizoxanide glucuronide was not measured.[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.

References

1.

Hadad GM, Abdel Salam, RA, Emara S. Validated and optimized high-performance liquid chromatographic determination of tizoxanide, the main active metabolite of nitazoxanide in human urine, plasma and breast milk. J Chromatogr Sci 2012;50:509-15. [PubMed: 22525879]

Substance Name

Nitazoxanide

CAS Registry Number

55981-09-4

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antiparasitic Agents