Benefit should outweigh risk

US FDA pregnancy category: C

Teratogenicity was not shown in animal studies in rats and rabbits. At doses up to 8 times the maximum recommended human dose, increased gestation duration was observed in rats. Pre and prenatal and postnatal pup loss and developmental retardation occurred in rats and rabbits and post-implantation loss was increased in rabbits at doses of 1 mg/kg or more. There are no controlled studies in pregnant women.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Safety has not been established

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

Comments: If used, monitor infant for toxicity such as sedation, hypotension, and hallucinations.

As a lipid soluble drug, it might be expected to pass into breast milk.

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