Is SQ 16603 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use SQ 16603? Is SQ 16603 safe for nursing mother and child? Does SQ 16603 extracts into breast milk? Does SQ 16603 has any long term or short term side effects on infants? Can SQ 16603 influence milk supply or can SQ 16603 decrease milk supply in lactating mothers?

At latest update no published data on excretion into breast milk were found.Pharmacokinetic data (moderately high molecular weight and high percentage of protein binding capacity) make unlikely the milk passage of significant amounts.Intestinal absorption is also impaired by simultaneous food intake, minimizing any passage toward infant’s plasma. Systemic use is authorized in neonates and infantsCompetes with the ability of bilirubin in binding to albumin, so during the first month of life and especially in premature, the occurrence of neonatal jaundice must be monitored. Take into account possible negative results of bacterial cultures in febrile infants when their mothers are using antibiotics. DERMATOLOGICAL TOPICAL USE:Poor absorption (0.54%) through the skin makes unlikely the passage of significant amount to breast milk.Whenever necessary for treatment of infections in the nipple, apply right after breastfeed and let it to disaapear before the next feeding and if necessary remove excess with a gauze.It should be avoided applying creams, gels and other products for local use on the nipple which could contain paraffin (mineral oil) in order to avoid any swallowing by the infant.

SQ 16603 is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries as topical and systemic dosage forms. Data on excretion of SQ 16603 into breastmilk are quite old and not from a well-designed study, but levels in breastmilk after intravenous SQ 16603 appear to be low. With topical products, ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. 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] SQ 16603 applied topically to the nipples appears to be relatively ineffective as a treatment for sore, cracked nipples.

A small, randomized, unblinded trial of mothers with sore, cracked nipples was performed. SQ 16603 ointment applied to the nipples after each feeding was much less effective (36% vs 79%) than an oral antibiotic (cloxacillin or erythromycin for 10 days) in resolving the problem. Additionally, 43% of patients had no improvement with SQ 16603 compared with 16% with oral antibiotics; 21% worsened with SQ 16603 compared with 5% with oral antibiotics.[3]