Is Ornidazole 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 Ornidazole. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Ornidazole is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. The amount of ornidazole in milk is low after administration of 3 doses totaling 2 grams intravenously perinatally. Measurements of infant plasma levels during breastfeeding have not been reported. No studies have evaluated adverse effects of ornidazole on the infant during breastfeeding, but presumably they are similar to those of the closely related drug, metronidazole, such as increased risk of oral and rectal Candida infections.
As with metronidazole, concern has been raised about exposure of healthy infants to ornidazole via breastmilk,[1] because of possible mutagenicity and carcinogenicity. Opinions vary among experts on the advisability of using ornidazole during longer-term therapy while breastfeeding, but avoidance of breastfeeding for 3 days after a single dose should allow milk levels to drop to negligible values because its half-life is similar to tinidazole.[2] Other drugs are available for bacterial vaginosis, and can be given vaginally, which should result in lower amounts in breastmilk.
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. Seventy-seven mothers who had a cesarean section and received ornidazole as one preoperative dose of 1000 mg and two postoperative doses of 500 mg each within 24 hours contributed 123 colostrum and milk samples for analysis. These values were used to create a population pharmacokinetic model of ornidazole excretion into milk. Simulated milk levels with this dosage regimen found the median peak milk levels to be 5.4 mg/L at 27 hours after delivery in patient with normal total bilirubin (<17 micromol/L) and 6.2 mg/L at 33 hours after delivery in patients with abnormal bilirubin (>17 micromol/L).[3]
Infant Levels. Relevant published information was not found as of the revision date.
“No published information” means the studies do not exist yet — not that Ornidazole 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 “Ornidazole” (ornidazole). 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.