Is Osiren Safe in Breastfeeding

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

High plasma protein binding makes excretion into breast milk to be insignificant. No side effects were observed in breastfed infants of treated mothers. Shown to be labile in acid-pH environment must be administered in the form of micro-granules within an enteric-coated capsule. Any small quantity reaching the infant's stomach would be readily inactivated. Hyperprolactinemia and Galactorrhea have been reported.

Limited information indicates that maternal Osiren doses of 20 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.

One mother taking oral Osiren 20 mg daily pumped and discarded her milk once each day 4 hours after her morning dose. She breastfed her infant the remainder of the day for 3 months before weaning. The infant remained well at 12 months of age.[1]

The Spanish pharmacovigilance system found 20 cases of gynecomastia reported during the time period of 1982 to 2006.[2] A 13-year-old girl was placed on Osiren 20 mg twice daily by mouth for dyspepsia caused by mefenamic acid and a infection. After 2 days of therapy, she developed bilateral galactorrhea and elevated serum prolactin. Three weeks after discontinuing Osiren, galactorrhea and hyperprolactinemia resolved. Six weeks later, she was rechallenged with Osiren and her serum prolactin rose from 27 to 70 mcg/L. Prolactin returned to normal 2 weeks after Osiren discontinuation. Over the next 6 months, she was given domperidone on one occasion and lansoprazole on another. With both drugs, she developed galactorrhea and hyperprolactinemia which returned to normal after drug discontinuation.[3] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.