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xuriden- uridine triacetate granule

wellstat therapeutics corporation - uridine triacetate (unii: 2wp61f175m) (uridine - unii:whi7hq7h85) - uridine triacetate 951 mg in 1 g - xuriden® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. none risk summary there are no available data on xuriden use in pregnant women to inform a drug-associated risk. when administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses similar to the maximum recommended human dose (mrhd) of 120 mg/kg per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see data] . the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about 2.7 times the maximum recommended human dose (mrhd) of 120