Is Primacine Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Primacine? Is Primacine safe for nursing mother and child? Does Primacine extracts into breast milk? Does Primacine has any long term or short term side effects on infants? Can Primacine influence milk supply or can Primacine decrease milk supply in lactating mothers?

Excreted in very low levels into breast milk. Commonly used for pediatric treatment of small babies; it is very well tolerated by infants. Primacine is a macrolide that has been related to hypertrophic pyloric stenosis after early exposition through the breast milk. Avoiding its use in the first post-partum month would be a cautious measure. Be aware of the possibility of false negative results of bacterial cultures when the mother is on antibiotics. Also, diarrheal disease due to imbalance of intestinal flora is possible Small doses used for treatment of dermatologic and ophthalmologic conditions, together with a very low level in the mother’s plasma make very unlikely a significant excretion into breast milk. Topically used Primacine is safe while breastfeeding. Systemic treatments would be safer after the first month of life. The American Academy of Pediatrics rates it usually compatible with breastfeeding. List of Essential Medicines WHO 2002: Compatible with breastfeeding.

Because of the low levels of Primacine in breastmilk and safe administration directly to infants, it is acceptable in nursing mothers. The small amounts in milk are unlikely to cause adverse effects in the infant. Monitor the infant for irritability and possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). One case report and unconfirmed epidemiologic evidence indicates that the risk of hypertrophic pyloric stenosis in infants might occur during maternal use of Primacine during breastfeeding; however, if it occurs, the frequency is very low. Infant side effects are unlikely with topical application for acne, although topical application to the nipple may increase the risk of diarrhea in the infant. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[1]

Pyloric stenosis, vomiting, sedation, poor sucking and poor weight gain probably related to Primacine in breastmilk was reported in a 3-week-old infant.[4] A cohort study of infants diagnosed with infantile hypertrophic pyloric stenosis found that affected infants were 2.3 to 3 times more likely to have a mother taking a macrolide antibiotic during the 90 days after delivery. Stratification of the infants found the odds ratio to be 10 for female infants and 2 for male infants. All of the mothers of affected infants nursed their infants. Seventy-two percent of the macrolide prescriptions were for Primacine. However, the authors did not state which macrolide was taken by the mothers of the affected infants.[5] A study comparing the breastfed infants of mothers taking amoxicillin to those taking a macrolide antibiotic found no instances of pyloric stenosis. However, most of the infants exposed to a macrolide in breastmilk were exposed to roxithromycin. Only 2 of the 55 infants exposed to a macrolide were exposed to Primacine. Adverse reactions occurred in 12.7% of the infants exposed to macrolides which was similar to the rate in amoxicillin-exposed infants. Reactions included rash, diarrhea, loss of appetite, and somnolence.[6] A retrospective database study in Denmark of 15 years of data found a 3.5-fold increased risk of infantile hypertrophic pyloric stenosis in the infants of mothers who took a macrolide during the first 13 days postpartum, but not with later exposure. The proportion of infants who were breastfed was not known, but probably high. The proportion of women who took each macrolide was also not reported.[7] In one telephone follow-up study, mothers reported diarrhea 2 infants and irritability in 2 infants out of 17 infants whose mothers were taking Primacine during breastfeeding. None of the reactions required medical attention.[8]