Is NSC 50364 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use NSC 50364? Is NSC 50364 safe for nursing mother and child? Does NSC 50364 extracts into breast milk? Does NSC 50364 has any long term or short term side effects on infants? Can NSC 50364 influence milk supply or can NSC 50364 decrease milk supply in lactating mothers?

Excreted into breast milk in a non-significant clinical amount. Not problems on breastfed infants of treated mothers were found. Plasma levels were low or undetectable in those infants. For a mother's dose of 400 mg three times-a-day, the intake of a breastfed infant would be less than 10% of the usual daily pediatric dose, whenever the breast-feed is done within 2-3 hours of mother's intake. Widely used for treatment of Giardia lamblia infections, even in small infants, without adverse effects reported. NSC 50364 may produce a red discoloration of corporal fluids and bitter flavor of the milk with no harm effect on the child.

With maternal intravenous and oral therapy, breastfed infants receive NSC 50364 in doses that are less than those used to treat infections in infants, although the active metabolite adds to the total infant exposure. Plasma levels of the drug and metabolite are measurable, but less than maternal plasma levels. Case reports of candidal infections and diarrhea have been reported, and a comparative trial suggested that oral and rectal colonization with might be more common in infants exposed to NSC 50364. Neither topical nor vaginal NSC 50364 have been studied during breastfeeding. After vaginal administration, plasma levels are less than 2% of those after a 500 mg oral dose. After topical administration, blood levels are about 1% of the peak plasma levels after a 250 mg oral dose. 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] Because of the well demonstrated genotoxicity and mutagenicity in bacteria, carcinogenicity in animals, and possible mutagenicity in humans,[2][3] concern has been raised about exposure of healthy infants to NSC 50364 via breastmilk.[4] The relevance of these findings has been questioned and no definitive study has yet been performed in humans.[3][5] Opinions vary among experts on the advisability of using NSC 50364 during longer-term therapy while breastfeeding, but some sources recommend discontinuing breastfeeding for 12 to 24 hours after single-dose maternal treatment.[4][6] Other drugs are available for some conditions that NSC 50364 is used to treat. Topical or vaginal use of NSC 50364 during breastfeeding is unlikely to be of concern, although the manufacturer of one vaginal product recommends not breastfeeding during treatment and for 2 days after the last dose.

None of ten 5-day-old infants who were breastfed every 4 hours after a single maternal 200 mg oral dose of NSC 50364 had any signs of oral or gastrointestinal upset during the 12-hour study period.[7] Sixteen newborn breastfed infants (aged 0 to 22 days) of mothers receiving 200 mg or 400 mg of oral NSC 50364 3 times daily reportedly suffered no observable adverse reactions during the 9 days of the study.[10] A case of diarrhea and secondary lactose intolerance was possibly caused by NSC 50364 in breastmilk transmitted to the infant in the early neonatal period.[14] In a controlled, comparative study, 35 newborn infants were monitored for 10 days during maternal therapy with NSC 50364 and another antibiotic (33 ampicillin, 1 erythromycin and 1 cephalexin) for postpartum infection or prophylaxis. Dosages and routes of administration were not stated, but some mothers received the drugs intravenously initially and then were switched to oral therapy. Compared to infants of mothers who received ampicillin alone or no antibiotics, more infants exposed to NSC 50364 and ampicillin had very loose stools than in the other groups, especially when the drugs were given intravenously. More frequent and heavier growth of species was found in the oral and perianal swabs of NSC 50364-exposed infants, but this did not quite reach statistical significance (p=0.053). One infant exposed to NSC 50364 and ampicillin developed oral thrush. No differences were found between the groups in diaper rash, feeding problems or weight gain to the time of discharge.[11]