Misoprostol

Drug Levels and Effects:




Summary of Use during Lactation:


Mispoprostol is a prostaglandin E1 analogue. Prostaglandin E1 and other prostaglandins appear normally in colostrum and milk.[1] Because of the low levels of misoprostol in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.


Drug Levels:


Maternal Levels.

Twenty women received misoprostol 600 mcg orally during the first 4 days postpartum and collected a total of 24 colostrum samples at various times during the first 5 hours after the dose. The average misoprostol concentration was highest in milk 1 hour after the dose at 20.9 ng/L. Average concentrations fell to 17.8 ng/L at 2 hours after the dose, 9.4 ng/L at 3 hours, 2.8 ng/L at 4 hours and <1 ng/l="" at="" 5="" hours="" after="" the="" dose.="" these="" colostrum="" levels="" result="" in="" an="" average="" infant="" dose="" of="" 7="" picograms/kg="" or="" 0.07%="" of="" the="" weight-adjusted="" maternal="">

Ten women who averaged 3.9 days postpartum received a single oral dose of misoprostol 200 mcg. Milk samples were obtained from one breast from 0.5 to 5 hours after the dose. The mean and median peak milk levels were 7.6 and 3.6 ng/L, respectively, at 1.1 hours after the dose. In 2 women, the peak milk level occurred 2 hours after the dose. By 5 hours, the median milk level was 0.2 ng/L. The half-life in milk averaged 1.1 hours.[3]

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


Relevant published information was not found as of the revision date.


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


Alternate Drugs to Consider:


(Oxytocic) Ergonovine,Methylergonovine,(Ulcers) Famotidine,Ranitidine,Omeprazole,Pantoprazole


References:


1. Shimizu T, Yamashiro Y, Yabuta K. Prostaglandin E1, E2, and F2 alpha in human milk and plasma. Biol Neonate. 1992;61:222-5. PMID:1610950
2. Abdel-Aleem H, Villar J, Gulmezoglu AM et al. The pharmacokinetics of the prostaglandin E1 analogue misoprostol in plasma and colostrum after postpartum oral administration. Eur J Obstet Gynecol Reprod Biol. 2003;108:25-8. PMID:12694965
3. Vogel D, Burkhardt T, Rentsch K et al. Misoprostol versus methylergometrine: pharmacokinetics in human milk. Am J Obstet Gynecol. 2004;191:2168-73. PMID:15592308



Substance Identification:




Substance Name:

Misoprostol

CAS Registry Number:

59122-46-2

Drug Class:


  • Abortifacient Agents, Nonsteroidal

  • Anti-Ulcer Agents

  • Prostaglandins

  • Oxytocics


  • Administrative Information:




    LactMed Record Number:


    554


    Last Revision Date:


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