Summary of Use during Lactation

Butalbital in breastmilk has caused poor feeding and vomiting in one infant. Other agents are preferred, especially while nursing a newborn or preterm infant. If butalbital is used, monitor the infant for sedation, poor feeding and poor weight gain.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. A 7-day-old breastfed infant's urine was qualitatively positive for barbiturate after his mother took a combination of butalbital 50 mg with acetaminophen 325 mg and caffeine 50 mg every 6 hours for 24 hours.[1]

Effects in Breastfed Infants

The mother of a newborn took a product containing acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg every 6 hours for 24 hours for a spinal headache, with the last dose a day prior to presentation at the emergency department. Her 7-day-old infant had a history of 1 to 2 days of poor feeding, lethargy and vomiting. The infant was somnolent, lethargic, and demonstrating diminished reflexes. The urine was qualitatively positive for barbiturate and had also had 1 mg/L of caffeine 15 hours after hospital admission. The infant's symptoms resolved within 24 hours. The symptoms were probably caused by butalbital.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Vohra V, Marraffa JM. Maternal use of acetaminophen-butalbital-caffeine product resulting in neonate butalbital exposure through breast milk. Clin Toxicol 2019;57:549. [Abstract]. doi: 10.1080/15563650.2019.1598646. [CrossRef]

Substance Name

Butalbital

CAS Registry Number

77-26-9

Drug Class

Breast Feeding

Lactation

Milk, Human

Barbiturates

GABA Modulators

Hypnotics and Sedatives