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Imipenem and Cilastatin use while Breastfeeding

Imipenem and Cilastatin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Imipenem is acceptable to use during breastfeeding. Limited information indicates that single maternal doses of imipenem up to 500 mg 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 beta-lactams, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels. Imipenem 500 mg and cilastatin 500 mg were infused intravenously over 30 minutes in 12 women. Imipenem appeared in the milk in concentrations of 0.21 to 0.52 mg/L between 1 and 5 hours after the dose in 10 of the women. The drug was usually detectable in only 1 to 3 of the samples taken hourly for 6 hours. In one woman, imipenem was undetectable (<0.2 mg/L) at all times up to 6 hours after the dose. Another woman had a detectable milk imipenem level of 1.84 mg/L only at 4 hours after the dose. Cilastatin was undetectable (<0.5 mg/L) in milk at all times in all women.[1]

Imipenem 500 mg and cilastatin 500 mg were infused intravenously over 30 minutes in 11 women. Seventy-six milk samples were obtained over the 6 hours following a dose. Imipenem was detectable in milk primarily at 2 to 4 hours after the dose. On average, the highest milk levels occurred 3 hours after the dose. All milk concentrations were less than 1 mg/L at all times up to 6 hours after the dose. The drug was undetectable in the milk of some women. Cilastatin was not measured.[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

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

References

1. Ito K, Izumi K, Takagi H et al. [Fundamental and clinical evaluation of imipenem/cilastatin sodium in the perinatal period]. Jpn J Antibiot. 1988;41:1778-85. PMID: 3210308

2. Matsuda S, Suzuki M, Oh K et al. [Pharmacokinetic and clinical studies on imipenem/cilastatin sodium in the perinatal period. A study of imipenem/cilastatin sodium in the perinatal co-research group]. Jpn J Antibiot. 1988;41:1731-40. PMID: 3062205

Imipenem and Cilastatin Identification

Substance Name

Imipenem and Cilastatin

CAS Registry Number

92309-29-0

Drug Class

Antiinfective Agents

Antibacterial Agents

Carbapenems

Administrative Information

LactMed Record Number

143

Last Revision Date

20130907

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