Dutasteride Capsule, Liquid Filled
Product Images NDC 72865-140

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 72865-140). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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0.5 mg 30s

This is a warning and dosage information for Dutasteride Capsules manufactured by XLCare Pharmaceuticals Inc, which contain 0.5 mg of dutasteride and should only be used by men. The capsules should not be chewed or opened, and not be used by women or children, and should be stored in a closed container at 20° to 25°C (68° to 77°F). If the printed safety seal under the cap is broken or missing, the capsules should not be used. The manufacturer is located in Lawrenceville, GA, and the capsules are manufactured by Ascent Pharmaceuticals Inc in Central Islip, NY.*

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0.5 mg 90s

This is a warning label, prescription information, and manufacturing details for Dutasteride capsules. It contains a warning advising that it should not be used by women or children, and women who are pregnant or could be pregnant should not handle the capsules. It also includes dosage instructions, storage directions, and manufacturer details. Each capsule contains 0.5 mg dutasteride. The capsules should be swallowed whole and should not be chewed or opened. If the printed safety seal under the cap is broken or missing, it should not be used. The product is manufactured by Ascent Pharmaceuticals, Inc. and distributed by XLCare Pharmaceuticals, Inc.*

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Fig1

This is a figure showing the Change from Baseline in AUASI in a treatment study. The study was randomized, double-blind and placebo-controlled. The study pooled findings from several trials. The figure displays a graph with AUA-ST scores on the Y-axis and the months of treatment on the X-axis. The ranges of the score are from 0 to 35. The study had two groups, Placebo n=212 and O Dutasteride n =212.*

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Fig2

This is a figure showing the percentage of subjects who developed acute urinary retention over a 24-month period, based on a randomized, double-blind, placebo-controlled trials pool, with two groups: the Placebo Group and the Dutasteride Group. The figure includes a graph with the percentage of patients on the y-axis and the months of treatment on the x-axis. The Placebo group saw a higher percentage of events and a lower number at risk throughout the treatment period compared to the Dutasteride group.*

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Fig3

The image shows a graph titled "Percent of Subjects Having Surgery for Benign Prostatic Hyperplasia over a 24-Month Period". The x-axis shows the months of treatment (6, 12, 18, and 24), and the y-axis shows the percentage of subjects having surgery. There are two lines on the graph representing the placebo group and the dutasteride group. The number of events (subjects having surgery), cumulative number, and number at risk are listed for each group at each time point.*

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Fig4

The text is describing a figure showing the percent change in prostate volume from baseline in randomized, double-blind, placebo-controlled trials. The figure displays the months of treatment on the X-axis and the percent change in prostate volume on the Y-axis. There are two lines shown, one for the placebo group and one for the dutasteride group. The dutasteride group has a higher percentage change in prostate volume reduction over the course of treatment. The figure also displays the number of participants in each group at baseline and at the end of treatment.*

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Fig5

Not available.*

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Fig6

This is a graph showing the International Prostate Symptom Score change from baseline over a 48-month period. It is from a randomized, double-blind, parallel-group trial called the CombAT Trial. There are three treatment groups: Dutasteride + Tamsulosin, Dutasteride 0.5mg, and Tamsulosin 0.4mg. The graph shows the number of patients in each group at different time points.*

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Fig7

This is a graph of the change from baseline for Qmax over a 24-month period in a randomized, double-blind, parallel-group trial called CombAT Trial. The graph shows a mean change from baseline for rLis of 9. There are different treatments represented in the graph, including a combination of Dutasteride and Tamsulosin, only Dutasteride or only Tamsulosin, however more information is not available due to the limited nature of the given text.*

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Structure

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Tab1

The text provides a table showcasing the adverse reactions reported in more than 1% of subjects over 24 months of dutasteride treatment versus a placebo group. These reactions are categorized by the time of onset and show that dutasteride caused significantly more cases of decreased libido, ejaculation disorders, and breast disorders. The role of dutasteride in the persistence of these sexual adverse reactions is unknown. The table distinguishes dutasteride from the placebo group in the category of impotence.*

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Tab2

The table presents adverse reactions reported over a 43-month period, where subjects receiving co-administration therapy of dutasteride and tamsulosin reported more adverse reactions than subjects receiving monotherapy with either dutasteride or tamsulosin. Adverse reactions reported include ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness. The table also clarifies that specific sexual adverse reactions are associated with dutasteride treatment, and may persist even after treatment is discontinued, although the role of dutasteride in this persistence is unknown.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.