Merrem Pregnancy Warnings
AU: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
UK: Use should be avoided.
US: This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B2
US FDA pregnancy category: B
Animal studies have failed to reveal evidence of fetal harm, although slight changes in fetal body weight were noted. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Merrem Breastfeeding Warnings
A mother was treated with 1 g IV every 8 hours for 7 days while her newborn was exclusively breastfed. Five samples of hindmilk were collected and the average breast milk level was 480 mcg/L. Estimated average and maximum infant intake were 71 mcg/kg/day (0.13% of weight-adjusted maternal dose) and 97 mcg/kg/day (0.18% of weight-adjusted maternal dose), respectively. When asked later, the mother stated her infant had no symptoms of oral thrush, watery diarrhea, or diaper dermatitis requiring antifungal therapy during therapy or during the month after therapy.
AU: Use is not recommended unless the benefit outweighs the risk to the infant.
UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Caution is recommended.
Excreted into human milk: Yes
Comments:
-This drug is not expected to cause harmful effects in the nursing infant.
-Clinical monitoring of infants for altered gastrointestinal flora has been suggested; loose bowel movement may occur in the nursing infant.
-This drug is considered compatible with breastfeeding according to the Therapeutic Guidelines Antibiotic Edition, version 14.
See references
