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Clinical studies have shown that with co-administration of Casodex, mean midazolam (a CYP 3A4 substrate) levels may be increased 1. Further, Casodex should not be used by women who are or may become pregnant. Data from a planned subgroup analysis of two of these trials in 1,627 patients with localized prostate cancer who were under watchful waiting, revealed a trend toward decreased survival in the Casodex arm after a median follow-up of 7. It is recommended that if Casodex is started in patients already receiving coumarin anticoagulants, prothrombin times should be closely monitored and adjustment of the anticoagulant dose may be necessary (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions). A single dose of Casodex that results in symptoms of an overdose considered to be life-threatening has not been established. coli, CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that Casodex does not have genotoxic activity.

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