Pregnancy There are no available human data for use during pregnancy to inform any drug-associated risks; oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures; maternal toxicity was observed in rabbits at lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m² basis) Lactation There are no data on human milk, effects on breastfed infant or milk production; developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for...
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