Question

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

Promp lactation summary

Promp is safe in breastfeeding
  • DrLact safety Score for Promp is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Promp is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Promp does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Promp 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 Promp usage in lactation

At latest update, relevant information on excretion into breast milk was not found. Due to a high serum-protein-binding capacity, excretion of Promp into breast milk is non-significant. Since it's neutralized by the acid pH of stomach, capsules with enteric coated granules are used. Because of this, it is thought that the small quantity of Promp that may reach the breast milk would be neutralized by infant's stomach. In addition, absorption is greatly decreased by the presence of food. Both Omeprazole and Pantoprazole pertain to the same chemical group with similar pharmacokinetics that are excreted in non-significant amount into the breast milk. Medication that has been used for treatment of newborn and premature infants. Hyperprolactinemia and galactorrhea have been reported by the use of such medication, though some authors have failed to show the same findings.

Answer by DrLact: About Promp usage in lactation

No information is available on the use of Promp during breastfeeding. However, Promp has been used safely in newborn infants, so it is unlikely that the amount in breastmilk would be harmful.

Promp Possible Effects in Breastfeeding

The Spanish pharmacovigilance system found 3 cases of gynecomastia associated with Promp reported during the time period of 1982 to 2006.[1] One case of elevated serum prolactin and galactorrhea was reported in a 21-year-old man. When omeprazole was substituted for Promp, the serum prolactin decreased to the normal range and galactorrhea ceased. Although this case occurred in Spain, it was not included in the report above.[2] A 13-year-old girl with a recent history of bilateral galactorrhea and hyperprolactinemia from omeprazole and domperidone on separate occasions was given Promp to prevent gastrointestinal irritation following intravenous diclofenac for a severe headache. After 3 days of Promp therapy, she again developed galactorrhea and an elevated serum prolactin that returned to normal a week after discontinuing Promp.[3] A 17-year-old woman using a progestin-containing IUD for 1 year began Promp 15 mg daily and presented after 1 week with bilateral galactorrhea and hyperprolactinemia of 92 mcg/L. Seventy-two hours after discontinuation of Promp, galactorrhea ceased. Four months later, serum prolactin was normal at 24.1 mcg/L with no recurrence of galactorrhea. The authors judged the adverse reaction likely to be caused by Promp.[4] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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