agosto 24, 2018 | Posted in:Blog
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Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 timesrespectivelyan oral human dose of 40 mgbased on a body surface area basis for a 60 kg personHoweverchanges in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mgsee Animal DataBecause of the observed effect at high doses of esomeprazole magnesium on developing bone in rat studiesNEXIUM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The carcinogenic potential of NEXIUM was assessed using studies of omeprazoleof which esomeprazole is an enantiomerIn two 24-month oral carcinogenicity studies in ratsomeprazole at daily doses of 1.73.413.844and 140.8 mg/kg/dayabout 0.4 to 34 times the human dose of 40 mg/day expressed on a body surface area basisproduced gastric ECL cell carcinoids in a dose-related manner in both male and female ratsthe incidence of this effect was markedly higher in female ratswhich had higher blood levels of omeprazoleGastric carcinoids seldom occur in the untreated ratIn additionECL cell hyperplasia was present in all treated groups of both sexesIn one of these studiesfemale rats were treated with 13.8 mg omeprazole/kg/dayabout 3.4 times the human dose of 40 mg/day on a body surface area basisfor 1 yearthen followed for an additional year without the drugNo carcinoids were seen in these ratsAn increased incidence of treatment-related ECL cell hyperplasia was observed at the end of 1 year94treated vs10controlsBy the second year the difference between treated and control rats was much smaller46vs26but still showed more hyperplasia in the treated groupGastric adenocarcinoma was seen in one rat2No similar tumor was seen in male or female rats treated for 2 yearsFor this strain of rat no similar tumor has been noted historicallybut a finding involving only one tumor is difficult to interpretA 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrencebut the study was not conclusive.
Hypersensitivity Reactionssee CONTRAINDICATIONSAcute Interstitial Nephritissee WARNINGS AND PRECAUTIONSClostridium difficile Associated Diarrheasee WARNINGS AND PRECAUTIONSBone Fracturesee WARNINGS AND PRECAUTIONSCutaneous and Systemic Lupus Erythematosussee WARNINGS AND PRECAUTIONSCyanocobalaminVitamin B-12Deficiencysee WARNINGS AND PRECAUTIONSHypomagnesemiasee WARNINGS AND PRECAUTIONSDrug Interactions Advise patients to let you know if they are takingor begin takingother medicationsbecause NEXIUM can interfere with antiretroviral drugs and drugs that are affected by gastric pH changessee DRUG INTERACTIONS
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