This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy categories: Not assigned.

Risk summary: No data are available on use of this formulation in pregnant women to inform a drug-related risk.

Comments:
-If treatment is necessary, some experts recommend close monitoring of maternal blood to reduce the risk of ototoxicity and nephrotoxicity in the fetus.
-Pregnant patients may require higher doses to achieve therapeutic concentrations.

Animal models have failed to reveal evidence of fetal harm. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some experts recommend using this drug with caution during breastfeeding.
-Systematic absorption after maternal oral administration was low.
-The effects in the nursing infant and on milk production are unknown.
-The WHO considers this agent a restricted use drug, but does not have data to inform of a recommendation.

See references