Summary of Use during Lactation

Sodium stibogluconate is no longer marketed in the US. Limited information indicates that maternal doses of sodium stibogluconate up to 1.4 grams daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants,[1] especially if the infant is older than 2 months. However, if withholding nursing during therapy is elected, breastfeeding can be reinstituted 24 to 48 hours after the last dose.

Drug Levels

Maternal Levels. A nursing mother was given 1 dose of sodium stibogluconate 1 gram intravenously, followed by intravenous doses of 1.4 grams (about 20 mg/kg of antimony) daily for 14 days. Numerous milk samples were obtained before and for 25 hours after the fifth and fourteenth doses of the drug. The average of the 2 trough values of antimony in milk was 0.7 mg/L; the average of the 2 peak concentrations was 3.5 mg/L at 4 hours after the dose.[1] (For comparison, average background antimony breastmilk concentrations range from 0.14 to 0.4 mcg/L).[2,3] After the sodium stibogluconate doses, milk antimony levels declined with a half-life of about 6 hours to a value of 0.7 mg/L at 23 hours after the dose.[1] Using the average of the peak and trough values, a fully breastfed infant would receive about 0.3 mg/kg daily of antimony or about 1.6% of the maternal weight-adjusted dosage.

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.

Berman JD, Melby PC, Neva FA. Concentration of Pentostam in human breast milk. Trans R Soc Trop Med Hyg 1989;83:784-5. [PubMed: 2559511]

2.

Abdulrazzaq YM, Osman N, Nagelkerke N, et al. Trace element composition of plasma and breast milk of well-nourished women. J Environ Sci Health A Tox Hazard Subst Environ Eng 2008;43:329-34. [PubMed: 18205064]

3.

Wappelhorst O, Kuhn I, Heidenreich H, et al. Transfer of selected elements from food into human milk. Nutrition 2002;18:316-22. [PubMed: 11934544]

Substance Name

Sodium Stibogluconate

CAS Registry Number

16037-91-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antiprotozoal Agents