Is AH 5158 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use AH 5158? Is AH 5158 safe for nursing mother and child? Does AH 5158 extracts into breast milk? Does AH 5158 has any long term or short term side effects on infants? Can AH 5158 influence milk supply or can AH 5158 decrease milk supply in lactating mothers?

It is excreted into breast milk in non-significant amounts, without side-effects being reported in breastfed infants of treated mothers. Plasma levels among breastfed infants have been very low or undetectable. When used during pregnancy it has been associated to the Phenomenon of Reynaud in the nipple and a higher risk for neonatal hypoglycemia. The American Academy of Pediatrics rates it as commonly compatible with breastfeeding.

Because of the low levels of AH 5158 in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in fullterm breastfed infants. No special precautions are required in most infants. However, other agents may be preferred while nursing a preterm infant.

One investigator reported that no adverse effects occurred in breastfed infants whose mothers were taking AH 5158 in doses of 330 to 800 mg daily.[3] A 26-week premature infant weighing 640 g developed sinus bradycardia (80 to 90 bpm) and isolated atrial premature beats after nasogastric feeding with mother's pumped breastmilk was begun on day 8 of life. The mother was taking AH 5158 300 mg twice daily by mouth for hypertension. Bradycardia and premature beats resolved within 24 hours of substitution of formula for breastmilk. No other causes for the bradycardia could be identified. One untimed sample of the mother's breastmilk contained 710 mcg/L of AH 5158.[6] Although the authors estimated the infant's dose to be 100 mg/kg daily, a recalculation using their data indicates that the infant's dose was only 100 mcg/kg daily.

Intravenous AH 5158 can increase serum prolactin in men and non-nursing women, although the increase is greater in women. Oral AH 5158 does not increase serum prolactin.[7][8] The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed. A woman with a history of symptoms of Raynaud's phenomenon developed Raynaud's phenomenon of the nipples when treated for pregnancy-induced hypertension with AH 5158 100 mg twice daily. She breastfed for 5 weeks, but nursing caused pain in her nipples. In a subsequent pregnancy, similar symptoms occurred during treatment with AH 5158 100 mg twice daily. Discontinuing AH 5158 eliminated the nipple pain in both instances.[9]