Category Not classified.—Based on findings from animal studies of other drugs that enhance GABAergic inhibition, may cause fetal harm. There are no available data on use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
With a low oral bioavailability (<5%) in adults, and an RID of only 1-2%, infant exposure is expected to be very low. There were no reports of effects on milk production. There are no data on the effects on a breastfed infant. Available data do not suggest a significant risk of adverse reactions to breastfed infants.
Avoid use in patients with ESRD with eGFR of <15 because of the potential accumulation of the solubilizing agent, betadex sulfobutyl ether sodium
No dose adjustment necessary.
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Last updated August 15 2022 20:48:12. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.