Category Not classified.—In animal studies, high doses of hydroxyzine were associated with developmental toxicity (structural anomalies and death), but the human data suggest low risk. Although a surveillance study found an increased risk of oral clefts, this defect has not been observed in other studies. Withdrawal or seizures have been reported in two newborns exposed near term.
No reports describing the use of hydroxyzine during lactation have been located. The molecular weight (about 448) is low enough that excretion into breast milk should be expected. The effects, if any, on the nursing infant are unknown.
Initiate dosing at lower end of recommended dose range as it may cause oversedation.
2019 BEE℞S Recommendation: Avoid. Highly anticholinergic; clearance reduced with advanced age, and tolerance develops when used as hypnotic; risk of confusion, dry mouth, constipation, and other anticholinergic effects or toxicity.
GFR > 50mL/min, no adjustment
GFR ≤ 50 ml/min, ↓ dose 50%
No adjustments necessary except for cases of 1° biliary cirrhosis, Δ dosing to Q24
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Last updated May 17 2021 17:22:54. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.