Dutasteride
Product Images NDC 68071-2610

This is a medication label for Dutasteride 0.5mg produced by NuCare Pharmaceuticals, Inc. It includes information such as the National Drug Code (NDC), lot number, manufacturer, expiration date, and dosage form (30 capsules). It also includes warnings to keep the medication out of reach of children and store it at a controlled temperature. Patients are advised to consult a doctor for medical advice about possible side effects and report any complaints to the FDA.*

The given text contains a figure (Figure 1) that shows the change in AUA-ST Score from baseline in randomized, double-blind, placebo-controlled trials pooled over a period of 24 months. The AUA-ST score ranges from 0 to 35. The figure shows the mean change from baseline in AUASI over time for placebo (n=212) and dutasteride (n=212) groups. The X-axis represents the months of treatment while the Y-axis represents the change from baseline in AUA-ST score.*

This is a figure that shows the percentage of subjects who developed acute urinary retention over 24 months of randomized, double-blind, and placebo-controlled trials. The graph shows two groups: the placebo group and the Dutasteride group. The number of patients at risk and the cumulative number of events in each group is also provided.*

This is a figure showing the percentage of subjects who underwent surgery for benign prostatic hyperplasia over a 24-month period in a randomized, double-blind, placebo-controlled trial. The graph displays the number of events and the number at risk for both the placebo and dutasteride groups.*

The text describes a graph that shows the percent change in prostate volume from baseline in a series of randomized, double-blind, placebo-controlled trials. The graph depicts data for both a placebo and a treatment with Dutasteride over a span of several months. The number of participants in each group is also shown.*

The text appears to be a figure caption showing a graph with different treatments and their change from baseline over 24 months in a double-blind trial. There are also mentions of different medication dosages. Therefore, it is not feasible to generate a useful description from the given text.*

This is a table providing information on the Adverse Reactions Reported in 1% of Subjects over a 24-Month Period and more Frequently in the Group Receiving Dutasteride than the Placebo Group in a Randomized, Double-blind, Placebo-Controlled Trials. It shows the types of adverse reactions, the onset time, and the percentage of subjects who reported these reactions. The adverse reactions listed are Impotence, Decreased Libido, Eaculation Disorders, and Breast Disorders which are associated with dutasteride treatment. These adverse reactions may persist after treatment discontinuation, but the role of dutasteride in this persistence is unknown. The table also includes information on the Placebo group for comparison.*

The table represents the adverse reactions reported over a 43-month period in 1% of subjects and more. The frequency of the reaction is based on the combination therapy group more than the groups received monotherapy with Dutasteride or Tamsulosin. The adverse reactions include ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness. The table also includes the time of onset of the reactions for each year from year one to year three. The combination therapy includes Dutasteride 0.5 mg once daily plus Tamsulosin 0.4 mg once daily. However, it is unclear about the role of dutasteride in sexual adverse reactions persisting after treatment discontinuation.*