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It is a non-steroidal anti-inflammatory drug (NSAID), derived from indole acetic acid, which is used for the symptomatic treatment of chronic musculoskeletal pain, to induce closure of a patent ductus arteriosus in premature babies and, topically, in certain ophthalmological processes. Oral, rectal or eye drop administration in three daily doses.
It is excreted into breast milk in non-significant clinically amounts. Usually, breast milk and infant plasma levels have been found to be undetectable. (Beaulac 1993, Lebedevs 1991)
There has not been side-effects described in children from treated mothers (Li 1994, Lebedevs 1991), except for a case reported in 1978 with convulsions in a newborn infant whose mother received a higher dose than recommended (Eeg 1978). However, a causal relationship was questioned by other author in the same publication.
It has been successfully used with no side-effects on treated mothers who had high levels of Prostaglandin E (PGE) whose infants were suffering of “physiologic diarrhea. (Li 1994)
This drug is used in neonates. Expert authors consider the use of this medication probably compatible during breastfeeding. (Hale, LactMed, Bordini 2016, Briggs 2015, Risser 2009, Østensen 2007, Nice 2004, Lee 1993). The American Academy of Pediatrics rates it as usually compatible with breastfeeding. (AAP 2001)
Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable, especially during the neonatal period and in the event of prematurity.