Question

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

Monolitum lactation summary

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

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

Monolitum Possible Effects in Breastfeeding

The Spanish pharmacovigilance system found 3 cases of gynecomastia associated with Monolitum 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 Monolitum, 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 Monolitum to prevent gastrointestinal irritation following intravenous diclofenac for a severe headache. After 3 days of Monolitum therapy, she again developed galactorrhea and an elevated serum prolactin that returned to normal a week after discontinuing Monolitum.[3] A 17-year-old woman using a progestin-containing IUD for 1 year began Monolitum 15 mg daily and presented after 1 week with bilateral galactorrhea and hyperprolactinemia of 92 mcg/L. Seventy-two hours after discontinuation of Monolitum, 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 Monolitum.[4] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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