Use should be avoided.

US FDA pregnancy category: Not assigned

Risk Summary:
-This drug can harm a developing fetus.

Comments:
-This drug contains alcohol which is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development.
-Verify the pregnancy status of females of reproductive potential before treatment initiation. Adequate methods of contraception should be encouraged during treatment and for 7 months after the last dose.
-Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies revealed maternal toxicity, embryo-fetal mortality and fetal abnormalities (ossification of caudal vertebrae, sternebrae and metacarpals, a decrease in implantations) at exposures below human exposures based on AUC. 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.

See references

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Due to the potential of serious adverse reactions in a breastfed child, women should not breastfeed during treatment and for 2 weeks after the last dose.

See references