HP Kit Use During Lactation
The HP Kit (Helicobacter pylori eradication therapy containing amoxicillin, clarithromycin, and omeprazole) can be safely used during breastfeeding, as all three components are compatible with lactation according to current guidelines. 1
Individual Component Safety Profile
Amoxicillin
- Amoxicillin is explicitly classified as "compatible" with breastfeeding by the European Respiratory Society/Thoracic Society of Australia and New Zealand (ERS/TSANZ) guidelines, representing the highest safety designation for antibiotics during lactation 1
- Penicillins and aminopenicillins are present in breast milk at low concentrations and are considered appropriate for use in lactating women 2
- The American Academy of Dermatology confirms amoxicillin as FDA Category B and compatible with nursing 1
Clarithromycin
- Clarithromycin is classified as "probably safe" during breastfeeding according to multiple international guidelines 3, 1
- Macrolides, including clarithromycin, are considered compatible with breastfeeding at recommended dosage ranges 2
- Human data suggest low risk despite animal studies showing adverse pregnancy outcomes 3
Omeprazole (Proton Pump Inhibitor)
- PPIs are recommended for use during lactation when clinically indicated, as the maternal benefit outweighs potential risk 3
- The 2025 British Society of Gastroenterology guidelines explicitly state that "medicines that are low risk in pregnancy are also low risk in breast feeding and should be continued" 3
Clinical Decision Algorithm
When prescribing HP Kit to a breastfeeding mother:
Confirm the infant is full-term and healthy - safety data assumes term, healthy infants 1
Proceed with standard HP eradication dosing:
Counsel the mother to continue breastfeeding - do not interrupt nursing, as benefits outweigh minimal medication exposure 3, 2
Essential Infant Monitoring
All breastfed infants whose mothers are taking the HP Kit should be monitored for:
- Gastrointestinal effects (diarrhea, gastroenteritis) due to alteration of intestinal flora 3, 1
- Unusual symptoms or changes in feeding patterns 1
- Very low risk of hypertrophic pyloric stenosis with macrolide exposure during the first 13 days of breastfeeding (risk does not persist after 2 weeks) 3, 1
Important Caveats
Timing Consideration for Clarithromycin
- While clarithromycin is safe overall, ideally avoid initiating macrolide therapy during the first 13 days postpartum if possible, due to the transient pyloric stenosis risk 1
- However, if H. pylori eradication is clinically urgent, the benefits of treatment outweigh this very low risk 3
Potential for False-Negative Cultures
- Antibiotics in breast milk could cause falsely negative cultures if the breastfed infant develops fever requiring evaluation 3, 1
- Inform pediatricians that the infant is exposed to antibiotics through breast milk if the baby requires infectious workup 1
Amoxicillin/Clavulanate Distinction
- The HP Kit typically contains amoxicillin alone, not amoxicillin/clavulanate 4, 5
- If amoxicillin/clavulanate (Augmentin) is substituted, note that it should not be used in women at risk of pre-term delivery, but for breastfeeding after term delivery, it remains fully compatible and safe 1
Strength of Evidence
The recommendation to use HP Kit during lactation is based on:
- High-quality guideline evidence from the European Respiratory Society (2020), British Society of Gastroenterology (2025), and American Academy of Dermatology 3, 1
- Consensus expert opinion that penicillins, macrolides, and PPIs are compatible with breastfeeding 2
- The principle that breastfeeding should not be interrupted for medications with established safety profiles 3, 2
The evidence strongly supports continuing breastfeeding while completing H. pylori eradication therapy, as the health benefits of lactation for both mother and child significantly outweigh the minimal theoretical risks of medication exposure through breast milk. 3, 2