Ampicillin and Sulbactam use while Breastfeeding

Ampicillin and Sulbactam Levels and Effects while Breastfeeding

Summary of Use during Lactation

Ampicillin and sulbactam is acceptable to use during breastfeeding. Limited information indicates that maternal doses of ampicillin 2 grams and sulbactam 1 gram produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, has been reported with penicillins, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels.In 3 mothers who received ampicillin 2 grams daily intramuscularly, milk levels ranged from 0.3 to 0.9 mg/L and in 3 mothers who received 4 grams dailyy intramuscularly milk levels ranged from 0.4 to 0.9 mg/L. In all cases, peak milk levels occurred 3 hours after the dose. The breastfed infant was estimated to receive from 0.08 to 0.2 mg daily of ampicillin with these doses.[1]

In 15 women receiving ampicillin 500 mg 4 times daily by intramuscular injection, average milk ampicillin levels were as follows: 0.11 mg/L at 30 minutes after the injection; 0.21 mg/L at 1 hour, 0.17 at 2 hours, 0.27 mg/L at 4 hours and 0.26 mg/L at 6 hours after the injection.[2]

In 15 women given a single 2 g dose of ampicillin intravenously, milk levels averaged 1.1 mg/L 2 hours after the dose.[3]

Milk was collected at random times after 0.5 or 1 g doses of sulbactam infused intravenously over 20 minutes. Little fluctuation occurred in milk levels over the first 8 hours after the dose with little difference in milk levels between the two dosages. Milk levels averaged 0.52 mg/L during this period with the highest level being 2.8 mg/L. Other levels from 10.5 to 20.5 hours after the dose ranged from 0.12 to 1.2 mg/L.[4]

A study in postpartum women with endometritis who received ampicillin 1 plus sulbactam 0.5 g or ampicillin 2 g plus 1 g of sulbactam infused intravenously over 20 minutes found the average milk levels of ampicillin to be 1.7 mg/L with the highest level observed 3 mg/L. Sulbactam milk levels averaged 0.58 mg/L with the highest level observed 2.8 mg/L.[5]

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

Effects in Breastfed Infants

Relevant published information on ampicillin and sulbactam was not found as of the revision date; however, there are data on ampicillin alone. In a prospective follow-up study, 5 nursing mothers reported taking oral ampicillin (dosage unspecified). One mother reported diarrhea in her infant. No rashes or candidiasis were reported among the exposed infants.[6]

A small, controlled, prospective study had mothers monitor their infants for signs of adverse effects (furring of the tongue, feeding difficulties, changes in stool frequency and consistency, diaper rash, and skin rash). Weight change and the development of jaundice were also recorded. No statistical differences in these parameters were found between the infants of the control mothers and those of mothers taking oral ampicillin.[7]

Possible Effects on Lactation

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

References

1. Pons G, Rey E. [Passage of antibiotics into maternal milk]. Med Mal Infect. 1994;24 (Special Issue 1):1088-106. DOI: doi:10.1016/S0399-077X(05)80220-3

2. Amiraslanova LA, Emel'yanova AI, Fursova SA et al. [Some aspects of ampicillin, kanamycin and cefuroxim pharmacokinetics in puerperant patients with endometritis.] Akush Ginekol (Mosk). 1985;Oct (10):14-7. PMID: 2934996

3. Zhang Y, Zhang Q, Xu Z. [Tissue and body fluid distribution of antibacterial agents in pregnant and lactating women]. Zhonghua Fu Chan Ke Za Zhi.1997;32(5):288-92. PMID: 9596854

4. Foulds G, Miller D, Knirsch AK et al. Sulbactam kinetics and excretion into breast milk in postpartum women. Clin Pharmacol Ther. 1985;6:692-6. PMID: 2998677

5. Foulds G, Miller RD, Stankewich JP et al. The pharmacokinetics of subactam and ampicillin in postpartum women. In: Spitzy KH, Karrer K, eds. Proc 13th Int Congress Chemother. 1983;1:23-17-23/22.

6. 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. PMID: 8498418

7. Campbell AC, McElnay JC, Passmore CM. The excretion of ampicillin in breast milk and its effect on the suckling infant. Br J Clin Pharmacol. 1991;31:230p. Abstract. PMC: PMC1368401

Ampicillin and Sulbactam Identification

Substance Name

Ampicillin and Sulbactam

CAS Registry Number

94935-63-4

Drug Class

Administrative Information

LactMed Record Number

14

Information from the National Library of Medicine's LactMed Database.

Last Revision Date

2014-01-16

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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