Dutasteride (Avodart®) Capsule 0.5 mg

Dutasteride is an oral 5-alpha-reductase inhibitor (5-ARI) indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) as monotherapy or in combination with tamsulosin. Dutasteride is used off-label for male-pattern baldness (androgenetic alopecia). According to the American Urological Association (AUA) guidelines, 5-ARIs (e.g., dutasteride, finasteride) may be used to prevent the progression of lower urinary tract symptoms (LUTS) secondary to BPH and to reduce the risk of urinary retention and future prostate-related surgery. The guidelines further state that 5-ARIs are appropriate and effective alternatives for men with LUTS secondary to BPH who have demonstrable prostate enlargement. 5-ARIs should not be used in the absence of prostatic enlargement. Compared to finasteride, the long half-life of dutasteride (5 weeks) may affect the duration of adverse effects upon discontinuation of the drug. In addition, dutasteride must be swallowed whole to avoid irritation of the oropharyngeal mucosa. Results from two large, randomized controlled trials indicate that there may be a decreased risk of low-grade prostate cancer but an increased risk of high-grade prostate cancer in patients receiving 5-ARIs. Therefore, the known treatment benefits of 5-ARIs should be weighed against the potential increased risk of prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with dutasteride and periodically thereafter. Because 5-ARIs inhibit the conversion of testosterone to dihydrotestosterone which can cause abnormalities in the external genitalia of the male fetus, pregnant women or women trying to conceive should not handle 5-ARIs since absorption through the skin may result in fetal exposure and severe adverse outcomes.