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Dutasteride is a second-generation alpha 5 reductase inhibitor approved in the United States for the treatment of benign prostatic hyperplasia. Dutasteride inhibits the conversion of testosterone to dihydrotestosterone, which is an important component in the formation and maintenance of prostate enlargement.
Dihydrotestosterone levels decrease during dutasteride treatment, but serum testosterone levels remain unchanged. Unlike α1-adrenoceptor antagonists, which have an immediate effect, dutasteride takes several months to have an effect on prostate size and symptoms of prostatic hyperplasia (hesitancy and dysuria).
Uses and functions of Dutasteride.
It is used for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) and also for patients with moderate to severe symptoms of BPH to reduce the risk of acute urinary retention (AUR) and surgery.
Pharmacological Effect of Dutasteride.
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). As an androgen, DHT plays a role in the initial development and subsequent enlargement of the prostate.
Testosterone is converted to DHT by the enzyme 5α-reductase, which has two isozymes, type I and type II. Type II isozymes are predominantly found in the reproductive tissues, whereas type I isozymes also play a role in the conversion of testosterone in the skin and liver.
Dutasteride is a specific competitive inhibitor of both the type I and type II isoenzymes of 5α-reductase and forms a stable enzyme complex with 5α-reductase. In vivo and in vitro dissociation assays of the enzyme complex have shown that the complex has a very low degree of dissociation.
Dutasteride does not bind to the human androgen receptor.
Adverse Reaction of Bulk Dutasteride Powder.
1. Treatment with this product alone: overseas clinical literature shows that in a two-year phase III placebo-controlled clinical trial, about 19 per cent of the 2,167 patients treated with dutasteride experienced adverse events in the first year of treatment.
The majority were reproductive events of mild to moderate severity, and the adverse event profile did not change significantly over the next two years of the open extension study.
2, the product and alpha-blocker tamsulosin combination: CombAT study of two years of data, dutasteride 0.5 mg (n = 1623) and tamsulosin 0.4 mg (n = 1611) once a day alone, as well as the combination of (n = 1610) comparison showed that in the first year of treatment and in the second year of treatment, the investigator judgement related to the combination of drugs dutasteride / tamsulosin The rates of adverse events were 22% and 5% for dutasteride monotherapy, 14% and 5% for dutasteride monotherapy, and 13% and 4% for tamsulosin monotherapy, respectively.
The higher incidence of adverse events in the combination group in the first year of treatment was due to the higher incidence of reproductive adverse events observed in this group, particularly ejaculatory disorders.
3. Other adverse events are detailed in the insert
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