Is Artemether and Lumefantrine safe while breastfeeding?

Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Artemether and Lumefantrine. The text below is quoted from that source — it is not our own verdict.

Summary of use during breastfeeding

Artemether and lumefantrine have not been studied in nursing mothers. Estimates of its excretion into breastmilk indicate that amounts in milk are much lower than the dose approved for use in African countries in young infants <5 kg (5 mg artemether plus 60 mg lumefantrine daily). If a mother requires artemether and lumefantrine, it is not a reason to discontinue breastfeeding. Tablets can be crushed and administered in breastmilk to enhance absorption in small infants.[1]

Effects on the breastfed infant

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

Effects on milk supply

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

Levels in milk

Maternal Levels. The excretion of artemether and lumefantrine in breastmilk was estimated from average maximum serum concentrations after a standard 6-dose regimen of artemether 40 mg and lumefantrine 240 mg daily, assuming a M/P ratio of 1.04 for artemether and 1.3 for lumefantrine. The authors estimated that a fully breastfed infant would receive 0.03 mg daily of artemether or less than 0.4% of the recommended dose for a 5 kg infant, and 5 mg daily of lumefantrine or less than 10% of the recommended dose for a 5 kg infant.[2]

A physiologically based pharmacokinetic model of the active artemether metabolite, dihydroartemesin, estimated that it has an RID of 0.2%.[3]

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

Alternatives LactMed lists

“No published information” means the studies do not exist yet — not that Artemether and Lumefantrine is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.

Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Artemether and Lumefantrine” (LM788). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.