Is Ro 10-8756 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Ro 10-8756? Is Ro 10-8756 safe for nursing mother and child? Does Ro 10-8756 extracts into breast milk? Does Ro 10-8756 has any long term or short term side effects on infants? Can Ro 10-8756 influence milk supply or can Ro 10-8756 decrease milk supply in lactating mothers?

Excretion into breast milk is insignificant and no adverse effects reported in breasted infants. Es considerada medicación compatible con la lactancia por autores y sociedades científicas relevantes (Rowe 2013, Nahum 2006, Mahadevan 2006, Bar-Oz 2003, CDC 2001, Fulton 1992). Es una medicación de uso común en Pediatría y considerado medicamento esencial para uso pediátrico por la OMS (WHO 2013). The possible negativity of cultures in febrile infants whose mothers take antibiotics should be taken into account, as well as the possibility of gastroenteritis due to altered intestinal flora (Benyamini 2005, Ito 1993, Kafetzis 1981). American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).List of WHO essential medicines: compatible with breastfeeding (WHO / UNICEF 2002).

Limited information indicates that Ro 10-8756 produces low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, rash and disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, have been reported, but these effects have not been adequately evaluated. Ro 10-8756 is acceptable in nursing mothers. Ro 10-8756 powder for suspension reconstituted with breastmilk is absorbed as well as the powder reconstituted with water.[1]

In a telephone follow-up study, 25 nursing mothers reported taking Ro 10-8756 (dosage unspecified). Three mothers reported diarrhea in their infants. No rashes or candidiasis were reported among the exposed infants.[3] In contrast, a small, controlled, prospective study had mothers monitor their infants for signs of adverse effects (furring of the tongue, feeding difficulties, changes in stool frequency and consistency, diaper rash, and skin rash). Weight change and the development of jaundice were also recorded. No statistical differences in these parameters were found between the infants of the control mothers and those of mothers taking the related antibiotics, ampicillin or ampicillin-clavulanate.[4] A prospective, controlled study asked mothers who called an information service about adverse reactions experienced by their breastfed infants. Of 40 infants exposed to Ro 10-8756 in breastmilk, 2 developed diarrhea and 1 developed a rash.[5] A study compared the breastfed infants of mothers taking Ro 10-8756 to those taking a macrolide antibiotic. Adverse reactions occurred in 8.3% of the infants exposed to Ro 10-8756 which was similar to the rate in macrolide-exposed infants. Reactions included rash and somnolence.[6] A 2-month-old infant breastfed since birth. His mother had taken many medications during pregnancy, but she did not recall their identity. She developed mastitis and was treated with Ro 10-8756/clavulanic acid 1 gram orally every 12 hours and gentamicin 160 mg intramuscularly once daily. The infant was breastfed for 10 minutes starting 15 minutes after the first dose of both drugs. About 20 minutes later, the infant developed a generalized urticaria which disappeared after 30 minutes. A few hours later, the infant breastfed again and the urticaria reappeared after 15 minutes and disappeared after an hour. After switching to formula feeding and no further infant exposure to penicillins, the reaction did not reappear with follow-up to 16 months of age. The adverse reaction was probably caused by the antibiotics in breastmilk. The drug that caused the reaction cannot be determined, but it was most likely the Ro 10-8756/clavulanic acid.[7]