Summary of Use during Lactation

Cefaclor is no longer marketed in the United States. Limited information indicates that maternal cefaclor produces low levels in milk which are not expected to cause adverse effects in breastfed infants. Occasionally disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush have been reported with cephalosporins, but these effects have not been adequately evaluated. Cefaclor is acceptable in nursing mothers.

Drug Levels

Maternal Levels. A single dose of cefaclor 250 mg was given orally to 2 nursing mothers. In one mother it was undetectable in milk. In the other, levels of 0.15 to 0.19 mg/L occurred 2 to 4 hours after the dose; by 5 hours it was undetectable. In 5 mothers who received a single 500 mg oral dose, an average peak level of 0.21 mg/L occurred 4 hours after the dose. In individual patients, peak levels of 0.18 to 0.35 mg/L occurred 2 to 5 hours after the dose.[1]

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

Effects in Breastfed Infants

In a telephone follow-up study, 5 nursing mothers reported taking cefaclor (dosage unspecified). One mother reported diarrhea in her infant. No rashes or candidiasis were reported among the exposed infants.[2]

Effects on Lactation and Breastmilk

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

References

1.

Takase Z, Shirafuji H, Uchida M. Clinical and laboratory studies of cefaclor in the field of obstetrics and gynecology. Chemotherapy (Tokyo) 1979;27 (Suppl 7):666-72.

2.

Ito S, Blajchman A, Stephenson M, et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 1993;168:1393-9. [PubMed: 8498418]

Substance Name

Cefaclor

CAS Registry Number

53994-73-3

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antibacterial Agents

Cephalosporins