Question

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

Zoltum lactation summary

Zoltum is safe in breastfeeding
  • DrLact safety Score for Zoltum is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Zoltum is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Zoltum does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Zoltum safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Zoltum usage in lactation

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.

Answer by DrLact: About Zoltum usage in lactation

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

Zoltum Side Effects in Breastfeeding

One mother taking oral Zoltum 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]

Zoltum Possible Effects in Breastfeeding

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 Zoltum 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 Zoltum, galactorrhea and hyperprolactinemia resolved. Six weeks later, she was rechallenged with Zoltum and her serum prolactin rose from 27 to 70 mcg/L. Prolactin returned to normal 2 weeks after Zoltum 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.
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.