Summary of use during lactation
Because of its extremely low levels in breastmilk, short half-life and safe use in infants in doses that are much higher than those excreted in breastmilk, ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers. Giving ibuprofen and acetaminophen on a fixed schedule for 24 hours after vaginal delivery appears to increase the breastfeeding rate. There is no difference in breastfeeding initiation rate between ibuprofen or acetaminophen alone after vaginal delivery.
Drug levels in milk and infant serum
Maternal Levels. Two early studies attempted measurement of ibuprofen in milk. In one, the patient’s dose was 400 mg twice daily, while in the second study of 12 patients, the dose was 400 mg every 6 hours. Ibuprofen was undetectable in breastmilk in both studies (<0.5 and 1 mg/L, respectively).[1,2] A later study using a more sensitive assay found ibuprofen in the breastmilk of one woman who took 6 doses of 400 mg orally over 42.5 hours. A milk ibuprofen level of 13 mcg/L was detected 30 minutes after the first dose. The highest level measured was 180 mcg/L about 4 hours after the third dose, 20.5 hours after the first dose. The authors estimated that the infant would receive about 17 mcg/kg daily (100 mcg daily) with the maternal dose of approximately 1.2 grams daily. This dose represents 0.0008% of the maternal weight-adjusted dosage[3] and 0.06% of the commonly accepted infant dose of 30 mg/kg daily (10 mg/kg every 8 hours). Single milk samples were taken from 13 women between 1.5 and 8 hours after the third dose of ibuprofen in a daily dosage regimen averaging 1012 mg daily (range 400 to 1200 mg daily). Of the 13 milk samples analyzed, the mean milk concentration was 361 mcg/L (range 164 to 590 mcg/L). The mean weight-adjusted percentage of the maternal dosage (relative infant dosage [RID]) was estimated to be <0.38%; however, the RID varied with the time postpartum and the milk protein content. The RID was highest in the colostral phase when the milk protein content was the highest (RID 0.6%). The estimated mean dosage for a fully breastfed infants was 68 mcg/kg daily or 0.2% of a pediatric dosage.[4] Infant Levels. Relevant published information was not found as of the revision date.
Effects in breastfed infants
At least 23 cases are reported in the literature in which infants (ages not stated) were breastfed during maternal ibuprofen use with no adverse effects reported.[1,3,5]
Effects on lactation and breastmilk
A randomized study compared the use of ibuprofen 400 mg plus acetaminophen 1 gram every 6 hours for 24 hours to the same combination on demand after normal vaginal delivery. Women who received the analgesics on a fixed schedule were more likely to breastfeed their baby (98% vs 88%) than those receiving analgesics on demand, even though their average pain scores were not different.[6] A double-blind study compared acetaminophen 1000 mg to ibuprofen for pain control after vaginal delivery. No difference was seen between the two treatments in the percentage of mothers who initiated breastfeeding of their infants.[7]
Alternative drugs to consider
Acetaminophen, Celecoxib, Diclofenac, Flurbiprofen, Indomethacin, Naproxen, Piroxicam
Source: Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, NCBI Bookshelf. Check LactMed for the most recent revision.
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