Dutasteride Capsule, Liquid Filled
Product Images NDC 63629-1222

This is a graph (Figure 1) showing the change in AUA-ST score (ranging from 0 to 35) over time (months of treatment) for a randomized, double-blind, placebo-controlled trial with pooled data. The mean change from baseline in AUASI is depicted for both a placebo group (n=212) and a group treated with Dutasteride (n=212).*

This is a figure presenting the percent of subjects who developed acute urinary retention over a 24-month period in a randomized, double-blind, placebo-controlled trial pool. The graph shows that the placebo group had a higher percentage of patients with the condition compared to the group treated with Dutasteride. The number of events and cumulative percentage is given for each group, as well as the number at risk at each time point.*

This is a figure showing the percent of subjects having surgery for benign prostatic hyperplasia over a 24-month period in randomized, double-blind, placebo-controlled trials, pooled. The Y-axis is the percentage of subjects, while the X-axis shows the months of treatment, from 6 to 24. The data is presented for both the placebo group and the dutasteride group, with the number of events and the number at risk given for each group at each time point.*

This is a graph showing the change in percentage of prostate volume from baseline in randomized, double-blind, placebo-controlled trials pooled. The horizontal axis shows the months of treatment and the vertical axis shows the percent change in prostate volume. The blue line represents the placebo group while the orange line represents the group treated with Dutasteride. There are also labels indicating the number of participants in each group at certain time points.*

This is a graph or chart displaying the International Prostate Symptom Score Change from Baseline over a 48-month period in a randomized, double-blind, parallel-group trial known as the CombAT Trial. The x-axis represents the number of months of treatment while the y-axis displays the score change from baseline. The chart shows the scores for three groups: International Prostate Symptom Score Change for a treatment of Dutasteride + Tamsulosin (n=1575), Dutasteride 0.5 mg (n=1592), and Tamsulosin 0.4 mg (n=1582) over a 48-month period.*

The text is a description of Figure 7 showing the Qmax change from baseline over a 24-month period in a randomized, double-blind, parallel-group trial, known as the CombAT Trial. The figure has a graph indicating the mean change from baseline at different months of treatment (0, 6, 12, 18, and 24). The treatments included Dutasteride + Tamsulosin, Dutasteride 0.5mg, and Tamsulosin 0.4mg.*

The provided text is a table showing adverse reactions of dutasteride and placebo groups over a 24-month period reported in more than 1% of subjects. Dutasteride usage showed sexual adverse reactions of impotence, decreased libido, and ejaculation disorders at different onset periods, while breast disorder was also reported. These adverse reactions could continue after the discontinuation of dutasteride, and the degree of persistence is unknown. The breast disorder includes breast tenderness and enlargement.*

This is a table presenting adverse reactions reported in a 43-month period in more than 1% of subjects receiving co-administration therapy with Dutasteride and Tamsulosin in comparison to subjects receiving only Dutasteride or Tamsulosin. It shows the percentage of subjects who experience sexual, breast, and dizziness adverse reactions at different periods of onset. Sexual adverse reactions are associated with Dutasteride treatment and may persist after discontinuation. The role of Dutasteride in this persistence remains unknown. The study includes various sexual-related adverse reactions such as anorgasmia, retrograde ejaculation, decreased semen volume, erectile dysfunction, and decreased libido. It also includes breast disorders such as enlargement, gynecomastia, and breast pain.*

This is a prescription medication called Dutasteride Capsule used to treat symptoms of benign prostatic hyperplasia (BPH) in men. Each capsule contains 0.5mg of dutasteride, and the medication should be kept out of reach of children. It should be stored at temperatures between 20°C and 25°C and dispensed in a tightly closed container with a child-resistant closure. The NDC number for this medication is 63629-1222-1.*