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Inactive Ingredientsanhydrous lactosecarnauba waxcrospovidoneFD&C Blue No2 aluminum lakehypromelloselactose monohydratemagnesium stearatemodified pharmaceutical glazepolyethylene glycolpolysorbate 80povidonepropylene glycoland titanium dioxide.
Biotransformation and disposition of raloxifene in humans have been determined following oral administration of 14 C-labeled raloxifeneRaloxifene undergoes extensive first-pass metabolism to the glucuronide conjugatesraloxifene-4glucuronideraloxifene-6-glucuronideand raloxifene-64diglucuronideNo other metabolites have been detectedproviding strong evidence that raloxifene is not metabolized by cytochrome P450 pathwaysUnconjugated raloxifene comprises less than 1of the total radiolabeled material in plasmaThe terminal log-linear portions of the plasma concentration curves for raloxifene and the glucuronides are generally parallelThis is consistent with interconversion of raloxifene and the glucuronide metabolites.
Raloxifene HCl was not genotoxic in any of the following test systemsthe Ames test for bacterial mutagenesis with and without metabolic activationthe unscheduled DNA synthesis assay in rat hepatocytesthe mouse lymphoma assay for mammalian cell mutationthe chromosomal aberration assay in Chinese hamster ovary cellsthe in vivo sister chromatid exchange assay in Chinese hamstersand the in vivo micronucleus test in mice.
SERMs were developed to reap the benefits of estrogen while avoiding the hormone’s potential side effectsRaloxifenea so-calleddesignerestrogencan act like estrogen on bone protecting its density but as an anti-estrogen on the lining of the uterus.
In a 31-weekopen-labelradiocalcium kinetics study33 early postmenopausal women were randomized to treatment with once-daily EVISTA 60 mgcyclic estrogen/progestin0.625 mg conjugated estrogens daily with 5 mg medroxyprogesterone acetate daily for the first 2 weeks of each monthhormone therapyor no treatmentTreatment with either EVISTA or hormone therapy was associated with reduced bone resorption and a positive shift in calcium balance82 mg Ca/day and60 mg Ca/dayrespectivelyfor EVISTA and162 mg Ca/day and91 mg Ca/dayrespectivelyfor hormone therapy
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generic evista is a prescription medication used to prevent and treat osteoporosis in postmenopausal women.