Dutasteride Capsule, Liquid Filled
Product Images NDC 68071-3732

This text contains information about a medication called Dutasteride 0.5mg, including details like lot numbers, NDC codes, expiration date, and manufacturer information. It also includes a warning to keep the medication out of reach of children and store it at a controlled temperature of 68-77°F. Additionally, it advises to consult a doctor for medical advice and provides contact information for reporting side effects to the FDA.*

This text provides a graph showing the change from baseline in AUASI (American Urological Association Symptom Index) score over 24 months of treatment in a randomized, double-blind, placebo-controlled trial. The graph compares the results between a placebo group and a group treated with Dutasteride. The AUA-ST score ranges from 0 to 35.*

This text provides data on the percentage of subjects developing acute urinary retention over a 24-month period in randomized, double-blind, placebo-controlled trials. The graph shows the comparison between the placebo group and the Dutasteride group at different time points (0, 6, 12, 18, and 24 months) of treatment. The numbers of events and the cumulative percentages are presented for each group, along with the corresponding numbers of patients at risk at each time point.*

This text provides data on the percentage of subjects who underwent surgery for Benign Prostatic Hyperplasia over a 24-month period in randomized, double-blind, placebo-controlled trials. It shows the number of events at different time points for both the placebo group and the Dutasteride group, along with the respective number at risk. The information offers insights into the effectiveness of Dutasteride in reducing the need for surgery in subjects with Benign Prostatic Hyperplasia.*

Description: The text provides data on 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. It includes information on the number of participants for each treatment group (Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg) at different time points during the trial.*

The provided text seems to describe a graph showing the change in Qmax over a 24-month period in a randomized, double-blind, parallel-group trial known as the CombAT Trial. The graph displays the mean change from baseline in Qmax for the treatment groups of Dutasteride + Tamsulosin, Dutasteride 0.5mg, and Tamsulosin 0.4mg. The data is observed at different time points - 0, 6, 12, 18, and 24 months.*

This data table provides information on adverse reactions reported in subjects over a 24-month period in a study comparing Dutasteride to a placebo. The adverse reactions, such as impotence, decreased libido, ejaculation disorders, and breast disorders, are shown with the percentage of subjects experiencing them in different time intervals (0-6 months, 7-12 months, 13-18 months, and 19-24 months). The table highlights that Dutasteride group had higher incidences of impotence, decreased libido, ejaculation disorders, and breast disorders compared to the placebo group. Additionally, it mentions that some sexual adverse reactions associated with Dutasteride treatment may persist even after treatment discontinuation, although the exact role of Dutasteride in this persistence is unknown.*

The text provides a detailed overview of adverse reactions reported over a 43-month period in subjects receiving coadministration therapy with Dutasteride and Tamsulosin. It includes information on adverse reactions such as ejaculation disorders, impotence, decreased libido, breast disorders, dizziness, and sexual dysfunction related to dutasteride treatment. The combination therapy involves Dutasteride 0.5 mg once daily plus tamsulosin 0.4 mg once daily. Additionally, it mentions specific sexual adverse reactions and breast disorders associated with dutasteride treatment, which may persist even after discontinuation of treatment.*