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Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. Over 2 years of treatment, drug-related ejaculation disorders occurred more frequently in subjects receiving combination therapy (9%) compared to Avodart (2%) or tamsulosin (3%) as monotherapy. If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus. 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. To avoid potential fetal exposure, women who are pregnant or may become pregnant should not handle Avodart Soft Gelatin Capsules. The relationship between long-term use of Avodart and male breast neoplasia is currently unknown.

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