Animal studies have revealed evidence of decreased neonatal viability and weaning indices, decreased body weight, and delayed reflex and physical development (including sexual maturation) when this drug was administered at a dose of 2.5 mg/kg/day. Fetal accumulation and delays in delivery may also be possible. No fetal or maternal adverse effects were observed when administered IV up to 12 mg/kg/day. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

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

Comments: May impair female fertility; unknown whether these effects are reversible.

See references

Use should be avoided.

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

Comments:
-Due to the potential for serious adverse events, including electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion in nursing infants, women should not breastfeed during treatment with this drug.

Milk levels in rats reached maximal levels 1 hour following IV administration of this drug and were up to 3 times the maternal plasma levels following an IV dose of 1 mg/kg (systemic exposure less than human therapeutic exposure based on AUC comparison).

See references