From the FDA Drug Label
Caution should be exercised when this product is administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be secreted in breast milk and since it is known that atropine is secreted in breast milk
- Key points:
- Caution is advised when using Lomotil (diphenoxylate) in nursing women
- The major metabolite, diphenoxylic acid, may be secreted in breast milk
- Atropine, a component of Lomotil, is known to be secreted in breast milk
- Clinical decision: Lomotil (diphenoxylate) should be used with caution in breastfeeding women, as it may be secreted in breast milk and potentially harm the infant 1
From the Research
Lomotil (diphenoxylate) should be used with caution during breastfeeding, as the active ingredients pass into breast milk in small amounts, posing a theoretical risk to the infant. The most recent and highest quality study on medication safety during breastfeeding, published in 2022 2, emphasizes the importance of selecting medications with the lowest risk to the infant and using current, accurate resources like LactMed to guide decision-making. When considering the use of Lomotil during breastfeeding, it is essential to weigh the potential benefits against the risks, as the medication can cause reduced gut motility, respiratory depression, or anticholinergic effects in breastfed infants. Key factors to consider include:
- The amount of medication that enters breast milk varies based on the maternal serum concentration and the pharmacologic properties of the medication.
- Prescribers should use current, accurate resources to guide decision-making.
- Safer alternatives like loperamide (Imodium) are preferred as first-line options for nursing mothers who need antidiarrheal medication.
- If Lomotil is necessary, use the lowest effective dose for the shortest duration possible and monitor the infant for unusual drowsiness, decreased feeding, constipation, or dry mouth.
- Mothers should stay well-hydrated while taking this medication, as dehydration can affect milk supply.
- For severe or persistent diarrhea, it's crucial to address the underlying cause rather than just treating symptoms with antidiarrheals, as noted in studies on drug excretion into breast milk 3 and gastrointestinal medications during breastfeeding 4. Additionally, a study published in 2019 5 highlights the importance of balancing the toxicity risk against the benefits of human milk, emphasizing that health benefits of lactation for both mother and child are significant, and a decision to withhold from this should not be taken lightly.