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Therefore, for interpretation of serial PSAs in a man taking Avodart, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. Although the effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters was not evaluated, the percent change in DHT concentrations was similar for Avodart alone compared with the combination treatment. 5-mg daily doses of Avodart in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment studies, each with 2-year open-label extensions. Most of the 4,844 subjects randomly assigned to receive combination, Avodart, or tamsulosin completed 2 years of double-blind treatment (79%, 80%, and 78%, respectively). Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter.
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