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

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.

Animal studies have failed to reveal evidence of teratogenicity at IV injection doses at clinically relevant systemic exposures. Preimplantation loss, minor skeletal abnormalities, and/or omphalocele was observed in animal models when given this drug during organogenesis as an IV injection at doses of at least 3 mg/kg/day. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 have not shown 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.

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Systemic exposure is low when administered via the ocular route. There are no data on the effects of this drug on milk production.

Caution is recommended; benefit should outweigh risk.

Excreted into human milk: Data not available
Excreted into animal milk: Unknown

Comment: The effects in the nursing infant are unknown.

See references