Summary of Use during Lactation

Fusidic acid is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries as topical and systemic dosage forms. Data on excretion of fusidic acid into breastmilk are quite old and not from a well-designed study, but levels in breastmilk after intravenous fusidic acid appear to be low.

With topical products, ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[1] Fusidic acid applied topically to the nipples appears to be relatively ineffective as a treatment for sore, cracked nipples.

Drug Levels

Maternal Levels. Seven women were given intravenous sodium fusidate 750 mg four times daily 4 hours apart on the first day of therapy. Milk samples taken at various times after the second dose had fusidic acid concentrations ranging from 0.005 to 0.86 mg/L.[2]

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

A small, randomized, unblinded trial of mothers with sore, cracked nipples was performed. Fusidic acid ointment applied to the nipples after each feeding was much less effective (36% vs 79%) than an oral antibiotic (cloxacillin or erythromycin for 10 days) in resolving the problem. Additionally, 43% of patients had no improvement with fusidic acid compared with 16% with oral antibiotics; 21% worsened with fusidic acid compared with 5% with oral antibiotics.[3]

References

1.

Noti A, Grob K, Biedermann M, et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317–25. [PubMed: 14623482]

2.

Lauen O. Tidsskr Nor Laegeforen. 1969;89:816–9. [Acute puerperal mastitis treated with Fucidin] [PubMed: 5793595]

3.

Livingstone V, Stringer LJ. The treatment of Staphyloccocus aureus infected sore nipples: A randomized comparative study. J Hum Lact. 1999;15:241–6. [PubMed: 10578803]

Substance Name

Fusidic Acid

CAS Registry Number

6990-06-3

Drug Class

Breast Feeding

Lactation

Antibacterial Agents

Anti-Infective Agents

Protein Synthesis Inhibitors