Dutasteride Capsule, Liquid Filled
Product Images NDC 63629-1223

The text describes a figure (Figure 1) that shows the change in AUA-ST score from baseline over time (0-24 months) for randomized, double-blind, placebo-controlled trials pooled. The AUA-ST score ranges from 0 to 35. There are two groups shown, placebo (n=212) and Dutasteride (n=212). The mean change from baseline in AUASI is also shown.*

The text describes a figure titled "Percent of Subjects Developing Acute Urinary Retention over a 24-Month Period" in a randomized, double-blind, placebo-controlled trials pooled study. The graph displays the percent of patients developing acute urinary retention over six-month intervals of treatment (0-6, 6-12, 12-18, and 18-24 months) on the X-axis and the percent of patients on the Y-axis. The data is divided into two groups; the placebo group, and the Dutasteride group. The placebo group had 28 events of cumulative percent at 6 months, 49 events at 12 months, 70 percent at 18 months, and the total number of people at risk decreased from 2,158 to 1,793 over 24 months. On the other hand, the Dutasteride group had 19 events of cumulative percent at 6 months, 27 events at 12 months, 31 percent at 18 months, and 30 cumulative percent at 24 months. The number of people at risk in the Dutasteride group decreased from 2,167 to 1,827 over 24 months.*

The text describes Figure 3 which shows the percentage of subjects who underwent surgery for Benign Prostatic Hyperplasia over a 24-month period in randomized, double-blind, placebo-controlled trials that were pooled. The graph shows the number of events and the number at risk in both the placebo and dutasteride groups at 6, 12, 18, and 24 months of treatment.*

The text describes a figure numbered 6, which shows the change in International Prostate Symptom Score over a 48-month period in a randomized, double-blind, parallel-group trial- CombAT Trial. The figure contains a line graph with different colors representing different treatments- Dutasteride+tamsulosin, Dutasteride 0.5mg, and Tamsulosin 0.4mg. The x-axis shows months of treatment, and the y-axis shows the score change from baseline.*

This table presents the adverse reactions reported in subjects who received Dutasteride over a 24-month period, including Impotence, a decreased libido, and ejaculation and breast disorders. The adverse reactions were more frequent in the group receiving Dutasteride than the placebo group, and some reactions, such as sexual adverse reactions, might persist even after treatment discontinuation, and the role of Dutasteride is unknown.*

The table presents a list of adverse reactions experienced by patients during a 43-month clinical trial. The adverse reactions included ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness. The trial involved a co-administration therapy group, a monotherapy group receiving Dutasteride, and a monotherapy group receiving Tamsulosin. The adverse reactions reported were more frequent in the co-administration therapy group than in the monotherapy groups. The table also provides information about the time of onset of these adverse reactions.*

This is a description of NILD, a Dutasteride capsule used in pharmaceuticals. Each capsule contains 0.5mg of Dutasteride, USP. It is important to keep this medication away from children and store it in a tight container at a temperature between 20-25°C. It is dispensed with a child-resistant closure and comes in a pack of 30 capsules. The text also includes a VSN code and an NDC number.*