Tolbutamide and Breastfeeding

Summary of use during lactation

Tolbutamide is no longer marketed in the United States. It is excreted into breastmilk in small amounts that should cause no harm to the breastfed infant. Monitor breastfed infants for signs of hypoglycemia such as jitteriness, excessive sleepiness, poor feeding, seizures cyanosis, apnea, or hypothermia. If there is concern, monitoring of the breastfed infant's blood glucose is advisable during maternal therapy with hypoglycemic agents.[1,2]

Drug levels in milk and infant serum

Maternal Levels. In 2 women who were 3 days postpartum, milk levels were measured 4 hours after ingestion of a 500 mg dose of tolbutamide. Milk levels averaged 18 mg/L in one and 3 mg/L in the other.[3] 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.

Alternative drugs to consider

Acarbose, Glipizide, Glyburide, Insulin, Metformin, Miglitol

References

1. Everett JA. Use of oral antidiabetic agents during breastfeeding. J Hum Lact 1997;13:319-219429368 PubMed
2. Berlin CM, Briggs GG. Drugs and chemicals in human milk. Semin Fetal Neonatal Med 2005;10:149-5915701580 PubMed
3. Moiel RH, Ryan JR. Tolbutamide orinase in human breast milk. Clin Pediatr (Phila) 1967;6:4806029660 PubMed