Is CCRIS 3461 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 3461? Is CCRIS 3461 safe for nursing mother and child? Does CCRIS 3461 extracts into breast milk? Does CCRIS 3461 has any long term or short term side effects on infants? Can CCRIS 3461 influence milk supply or can CCRIS 3461 decrease milk supply in lactating mothers?

Less than 0.05% of the maternal dose of CCRIS 3461 is excreted in milk (AEMPS 2002, Puri 1987). Early exposure to macrolides (especially erythromycin, see specific information) has been linked to the occurrence of hypertrophic pyloric stenosis (Goldstein 2009, Chin 2001), including through breast milk, so it may be prudent to avoid them during the first month of breastfeeding. Be aware of false negative results of bacterial cultures obtained from febrile infants whose mothers are on antibiotics, as well as the possibility of gastroenteritis due to altered intestinal flora (Ito 1993).

CCRIS 3461 is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Because of the low levels of CCRIS 3461 in breastmilk, it would not be expected to cause adverse effects in breastfed infants. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). Unconfirmed epidemiologic evidence indicates that the risk of hypertrophic pyloric stenosis in infants might be increased by maternal use of CCRIS 3461 during breastfeeding.

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. Most of the macrolide prescriptions were for erythromycin, but 19% were for CCRIS 3461. However, the authors did not state which macrolide was taken by the mothers of the affected infants.[3] 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.[4] A study comparing the breastfed infants of mothers taking amoxicillin to those taking a macrolide antibiotic found no instances of pyloric stenosis. Sixty-seven percent of the infants exposed to a macrolide in breastmilk were exposed to CCRIS 3461. 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.[5]

In a double-blind, controlled study in Gambia, women who were nasopharyngeal carriers of , or group B streptococcus were given a single 2 gram dose of azithromycin during labor. Milk samples from women who received azithromycin had 9.6% prevalence of carriage of the organisms compared to 21.9% in women who received placebo. Nasopharyngeal carriage in mothers and infants was also reduced on day 6 postpartum.[7]