Avodart ®  (dutasteride)

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Avodart ®  by GlaxoSmithKline

Avodart ®  is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

• Improve symptoms
• Reduce the risk of acute urinary retention
• Reduce the risk of the need for BPH-related surgery

(Currently in trial phase for treatment of alopecia).

FDA New Drug Application Number 21-319/S-001: 10-9-2002 Avodart ®  (dutasteride) soft-gelatin capsules.

FDA New Drug Application Number 21-319: Approved 11-20-2001 for treatment of benign prostatic hyperplasia (bph). Approvals in other markets are pending.

Dutasteride is a recently approved drug developed by GlaxoSmithKline for treatment benign prostatic hyperplasia (BPH).

Dutasteride is being developed for the treatment of male pattern Baldness (MPB). Dutasteride, which is taken in tablet form, has shown dramatic success in restoring hair to bald men in trials.

It interferes with 5-alpha-reductase enzymes that break down the male hormone testosterone and turn it into dehydrotestosterone (DHT) - which causes hair to thin dramatically in later life.

Chemical Formulae: C27H30F6N2O2. 528.53.

Dutasteride (also known as Avolve™, Avodart ® ™) is a new revolutionizing method for treating hair loss, benign prostatic hyperplasia (BPH). Dutasteride is a recently approved drug developed by GlaxoSmithKline.

The Oral (tablet form) Drug is approved both the in the United States of America and in Europe, Dutasteride was approved on the 9th of October, 2002: by the FDA (Food & Drug Administration) under the trade name (Also known as Avolve™, Avodart ® ™) . In research by different companies Dutasteride has shown dramatic success in restoring hair to bald men in trials. Dutasteride works by interfering with 5-alpha-reductase enzymes that break down the male hormone testosterone and turn it into dehydrotestosterone (DHT), which causes hair to thin dramatically in later life.

Is Dutasteride safe?
Clinical trials of Dutasteride showed that it was generally well tolerated. Most side effects were mild or moderate and generally went away while on treatment in both the Dutasteride and placebo groups.

Drug-related side effects during the first six months were as follows:

The incidence of most drug-related sexual side effects decreased with duration of treatment. The incidence of drug-related breast tenderness and breast enlargement remained constant over the treatment period. Ejaculate volume may be decreased in some patients with continued treatment. This decrease did not appear to interfere with normal sexual function.

Dutasteride should not be used in women and children. Women who are pregnant or may become pregnant should not handle this medicine because of possibility of absorption and subsequent potential risk to a male foetus.

Men with liver disease should talk to their doctor before taking Dutasteride.

Men with an allergic reaction to Dutasteride or its ingredients should not take it.

Men treated with Dutasteride should not donate blood until at least six months after their final dose to prevent the medicine going to a pregnant woman through a blood transfusion.

How long does it take before Dutasteride work?
It may take up to 3 to 6 months for this medicine (Dutasteride) to work. Do not stop taking this medicine without checking with your doctor. Be sure to keep all laboratory and doctor appointments while you are taking this medicine.

Dutasteride is known as Avolve™ in the US, whilst in Europe it's known as Avodart ® ™, this is very common for different medicines, it's mostly due to different regulations in the US and Europe, both have been approved in Europe and the US.

Dutasteride, Avolve™, Avodart ® ™ are all a product by GlaxoSmithKline.

Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: A randomized, double-blind, placebo-controlled, phase III study
Avodart ®  May Help You Boost Testosterone and Lose Weight
Avodart ®  Reduces Risk of Prostate Cancer By Over 22%, But May Increase Risk of Cardiac Failure
Dutasteride versus finasteride
New study shows Dutasteride improves male pattern hair loss in identical twins
Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia
Use of Avodart ®  in androgenetic alopecia or male pattern baldness (hairloss)
Comparison of dutasteride (Avodart ®  with finasteride (Proscar)
Efficacy and safety of long-term treatment with the dual 5alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia
Effective suppression of dihydrotestosterone (DHT) by dutasteride, a novel, dual 5 alpha reductase inhibitor
A model for the turnover of dihydrotestosterone in the presence of the irreversible 5 alpha-reductase inhibitors GI198745 and finasteride
Glaxo GG745
Pharmacokinetic parameters and mechanisms of inhibition of rat type 1 and 2 steroid 5alpha-reductases: determinants for different in vivo activities of GI198745 and finasteride in the rat.
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