Azithromycin use while Breastfeeding

Drugs containing Azithromycin: Zithromax, Azithromycin Dose Pack, Z-Pak, Azasite, Zmax

Azithromycin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because of the low levels of azithromycin in breastmilk and use in infants in higher doses, it would not be expected to cause adverse effects in breastfed infants. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). Unconfirmed epidemiologic evidence indicates that the risk of hypertrophic pyloric stenosis in infants might be increased by maternal use of macrolide antibiotics during breastfeeding.

Drug Levels

Maternal Levels. A woman who was 1 day postpartum was given 1 g of azithromycin orally. Forty-eight hours later her milk azithromycin was 0.64 mg/L. An oral regimen of 500 mg daily for 5 days was started and more milk samples were obtained. One hour after the first dose, breastmilk contained 1.3 mg/L and 30 hours after the third dose milk contained 2.8 mg/L.[1] Because of the slow clearance and accumulation of azithromycin, it is difficult to interpret these milk levels. The dose that the infant would receive in milk would gradually increase for several days because maternal blood levels would increase until steady-state had been reached. If the level of 2.8 mg/L is used as an approximate trough level, an exclusively breastfed infant would receive a minimum of 0.42 mg/kg daily compared to the dose of 5 to 10 mg/kg daily used in infants of 6 months and over.

In a study of 30 women given azithromycin 500 mg intravenously 15, 30 or 60 minutes prior to incision for cesarean section, 8 women subsequently breastfed their infants. Multiple breastmilk samples were collected during the first 8 hours postpartum and then once again between 12 and 48 hours postpartum. Azithromycin persisted in breastmilk up to 48 hours after a dose with a median breastmilk concentration of 1713 mcg/L at a median of 30.7 hours after the dose, and a breastmilk half-life of about 24 hours. The authors stated that the overall exposure of the infant was minimal and not likely to be clinically important.[2]

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

Effects in Breastfed Infants

A cohort study of infants diagnosed with infantile hypertrophic pyloric stenosis found that affected infants were 2.3 to 3 times more likely to have a mother taking a macrolide antibiotic during the 90 days after delivery. Stratification of the infants found the odds ratio to be 10 for female infants and 2 for male infants. All of the mothers of affected infants nursed their infants. Most of the macrolide prescriptions were for erythromycin, but only 7% were for azithromycin. However, the authors did not state which macrolide was taken by the mothers of the affected infants.[3]

A retrospective database study in Denmark of 15 years of data found a 3.5-fold increased risk of infantile hypertrophic pyloric stenosis in the infants of mothers who took a macrolide during the first 13 days postpartum, but not with later exposure. The proportion of infants who were breastfed was not known, but probably high. The proportion of women who took each macrolide was also not reported.[4]

A study comparing the breastfed infants of mothers taking amoxicillin to those taking a macrolide antibiotic found no instances of pyloric stenosis. However, most of the infants exposed to a macrolide in breastmilk were exposed to roxithromycin. Only 10 of the 55 infants exposed to a macrolide were exposed to azithromycin. Adverse reactions occurred in 12.7% of the infants exposed to macrolides which was similar to the rate in amoxicillin-exposed infants. Reactions included rash, diarrhea, loss of appetite, and somnolence.[5]

Eight women who were given azithromycin 500 mg intravenously 15, 30 or 60 minutes prior to incision for cesarean section breastfed their newborn infants. No adverse events were noted in their infants.[2]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Clarithromycin, Erythromycin

References

1. Kelsey JJ, Moser LR, Jennings JC et al Presence of azithromycin breast milk concentrations: a case report. Am J Obstet Gynecol. 1994;170:1375-6. PMID: 8178871

2. Sutton A, Acosta E, Larson K et al. Azithromycin accumulates in breast milk following a single dose for cesarean prophylaxis. Am J Obstet Gynecol. 2014;210 (1 Suppl):S235. Abstract.

3. Sorensen HT, Skriver MV, Pedersen L et al. Risk of infantile hypertrophic pyloric stenosis after maternal postnatal use of macrolides. Scand J Infect Dis. 2003;35:104-6. PMID: 12693559

4. Lund M, Pasternak B, Davidsen RB et al. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: Nationwide cohort study. BMJ. 2014;348:g1908. PMID: 24618148

5. Goldstein LH, Berlin M, Tsur L et al. The safety of macrolides during lactation. Breastfeed Med. 2009;4:197-200. PMID: 19366316

Azithromycin Identification

Substance Name

Azithromycin

CAS Registry Number

83905-01-5

Drug Class

Anti-Bacterial Agents

Anti-Infective Agents

Macrolides

Administrative Information

LactMed Record Number

336

Last Revision Date

20140515

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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