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AVODART™
/ DUTASTERIDE
The Biggest News In
Hair Loss Treatment Since Propecia
FDA
clearance for Avodart or dutasteride was granted to GlaxoSmithKline
on October 9, 2002. This is the biggest news in hair loss treatment
since Propecia. This
page is updated regularly based on discussions in DUTASTERIDE
FORUM.
If
you want the latest discussions, debates and developments about
Avodart or Dutasteride, visit the DUTASTERIDE
FORUM.
But
if you just want to read about forum summaries and important issues
about Avodart or Dutasteride on an ongoing basis, this page will be
very helpful. Most information here are courtesy of posters in the
Dutasteride Forum. TABLE
OF CONTENTS 
What
is Avodart or Dutasteride?
Active ingredients
Topical Dutasteride
Dutasteride vs Finasteride
Standard does
Maximum effect
Side effects, warnings, concerns
Optimal dose for hair loss
Administration with or without food
Genuine Avodart
Storage
Half-life
and dosing schemes
Availability
and pricing information
Getting a script
Unofficial
results as of Jan 9th, 2003
WHAT
IS AVODART OR DUTASTERIDE?
After
30 Dutasteride forums in HairSite
and endless speculation for almost two years, Dutasteride is finally
a reality under the brand name Avodart™ !
The FDA approval for NDA#21-319/s-001 was given on October 9, 2002
and the label was posted on the same day.
This is the biggest news in hair loss treatment since FDA's
clearance for Propecia in December 1997. The interesting thing is
that Avodart is NOT a hair loss drug !!
Avodart™ (Dutasteride) is approved for the treatment of Benign
Prostatic Hyperplasia (BPH). Not to be mistakened with prostate
cancer, BPH is a non-cancerous enlargement of the prostate glands.
It is fairly common among older men aged 50 or above. BPH usually
manifest in a variety of lower urinary tract symptoms (LUTS) such as
urinary frequency, urgency, nighttime urination, decrease in urinary
stream, incomplete emptying and incontinence etc.
Avodart is a synthetic 4-azasteroid compound. It is the first FDA
approved medication that can inhibit both types of 5-alpha reductase
(5AR), an enzyme that is commonly believed to responsible for the
conversion of testosterone to 5 alpha-dihydrotestosterone (DHT). It
is widely suggested that DHT is the main androgen responsible for
prostate growth as well as male pattern baldness.
ACTIVE
INGREDIENTS
Avodart standard dosage is 0.5mg of the active ingredient
dutasteride per soft gelatin capsule. The capsule is compounded by
dissolving 0.5mg of dutaseride in a combination of mono-di-glycerides
caprylic/capric acid and butylated hydroxytoluene. Other ingredients
include BSE-free bovine gelatin, glycerin and yellow ferric oxide.
TOPICAL
DUTASTERIDE
If you are able to obtain Dutasteride in its raw form, you might
even be able to compound your own Dutasteride topical solution. It
was reported in Avodart's prescribing information that the
medication is absorbed through the skin as well. Dutasteride in its
raw form is a white-yellowish powder. It is insoluble in water but
can easily be dissolved in ethanol (44mg/mL), methanol (64 mg/mL)
and polyethylene glycol 400 (3mg/mL). However, please note
that effectiveness of Dutasteride or Avodart as a hair loss
treatment has not been clinically established.
You
may want to follow this thread
for more thorough discussion about topical dutasteride.
DUTASTERIDE
vs FINASTERIDE
Unlike Finasterdie (Propecia or Proscar) which only inhibits Type II
5AR, Dutasteride functions as a dual 5AR inhibitors and have been
proven to be more effective as an treatment for BPH and possibly
pattern hair loss or baldness. According to GSK, Dutasteride has
shown to exhibit significantly less inter-individual variation in
the level of DHT suppression compared to Finasteride.
A comparison between Avodart (Dutasteride) and Proscar (Finasteride
5 mg) can be found in Dutasteride
forum.
STANDARD DOSE
Scientists have evaluated the effectiveness of Dutasteride at
different daily dosage, ranging from 0.01 mg, 0.05 mg, 0.5 mg, 2.5
mg, and 5.0 mg per day. It was found that the highest suppression of
DHT was achieved with 2.5 mg or 5.0 mg per day. At a daily dosage of
2.5 mg or 5.0 mg, Dutasteride suppresses close to 100% of the DHT
whereas 5.0 mg daily dosage of Finasteride only suppresses close to
70% of the DHT. According to information provided by GSK, the level
of DHT suppression does not seem to different significantly between
2.5 mg and 5.0 mg. And at a daily dose of 0.5mg, DHT inhibiton is
close to 90%. Please also read below OPTIMAL DOSE FOR HAIR LOSS.
MAXIMUM
EFFECT
According to Avodart or dutasteride's prescribing information, the
maximum effect of dutasteride can be observed within 1 to 2 weeks.
"After 1 and 2 weeks of daily dosing with dutasteride 0.5mg,
median serum DHT concentrations were reduced by 85% and 90%
respectively." It was further reported that test patients
treated with a daily dosage of 0.5mg dutasteride for 2 years, the
median decrease in serum DHT concentration was over 92% for both
year 1 and year 2 of the 2-year trial.
SIDE
EFFECTS, WARNINGS, CONCERNS
1) Women or children should not use Avodart™ or dutasteride.
2) Women who are pregnant or may be pregnant should not handle
Avodart™ for fear of potential risks to a male fetus.
3) No measurable bone mineral density level change was observed in
test patients after a 52 weeks trial.
4) Men using Avodart™ or dutasteride should not donate blood until
at least 6 months after the medication was last used for fear of
possible administration of dutasteride tainted blood to pregnant
female transfusion patient.
5) Men with liver problems should not use Avodart™.
6) Patients' ejaculate volume might decrease as a result of the
medication. A small number of the test patients experienced
impotence and a reduction in libido.
7) No clinically significant change in hormone levels were observed
in test patients.
8) No clinically significant changes in sperm concentration, sperm
motility or sperm morphology although some subjects reported
reduction in ejaculate volume.
9) A 2-year statistical summary showed that sexual adverse events
such as impotence, decreased libido, and ejaculation disorder
decreased with the duration of the treatment. Fewer incidences of
adverse sexual events were reported over time.
OPTIMAL DOSAGE FOR HAIR LOSS
For the treatment of BPH, the official recommendation from GSK is to
take 1 x 0.5mg capsule orally every day with or without food.
However,
it appears that for treating hair loss, a daily dose of 2.5mg daily
seems to generate the best results. See Dutasteride
Results.
Also,
please follow this thread
in Dutasteride Forum which discussed the effect of Avodart on serum
DHT vs scalp DHT.
 0.5mg
Dutasteride inhibits ~ 92% serum DHT and 55% scalp DHT
2.5mg
Dutasteride inhibits ~ 95% serum DHT and 82% scalp DHT
DarkMage
and Bryan in the Dutasteride forum have also provided very valuable
information about the optimal daily dose for dutasteride. You can
find their charts and analysis at "Optimal
Daily Dose".
WITH
OR WITHOUT FOOD
Please read Bryan's
post and his interpretation about whether Avodart should be
taken with or without food.
GENUINE
AVODART™
Please note that genuine Avodart™ are oblong, opaque, dull yellow,
gelatin capsules with the word "GX CE2" clearly printed in
red on one side. Avodart™ is packaged in bottles of 100 (NDC
0173-0712-00) with child resistant closures. You may also find
genuine Avodart™ in blister packs of 70 capsules (NDC
0173-0712-01).
STORAGE
15-30 degrees Celsius or 59 - 86 degrees F.
HALF-LIFE
Discussions
here about half-life are mostly courtesy of Bryan in Dutasteride
Forum.
Half-life
refers to the
time (usually in hours) required for one-half the dose of a drug to
be excreted from the body. The following half-life information about
Avodart™
or
dutasteride is found in the prescribing information:
"The
terminal half-life of dutasteride is approximately 5 weeks at steady
state. The average steady-state serum dutasteride concentration was
40 ng/mL following 0.5 mg/day for 1 year. Following daily dosing,
dutasteride serum concentrations achieve 65% of steady-state
concentration after 1 month and approximately 90% after 3 months.
Due to the long half-life of dutasteride, serum concentrations
remain detectable (greater than 0.1 ng/mL) for up to 4 to 6 months
after discontinuation of treatment. "
Avodart
or Dutasteride has relatively much longer half-life than Propecia.
However, it does not necessarily mean that you can reap substantial
cost savings because in the long run, you have to sustain the same
amount of medication in your body in order to see results. You might
be able to "defer" the money you spent on Avodart, but not
cutting the overall amount you spend. The real significance of long
half-life is that it allows for very flexible dosing schemes. You
can take a small amount daily or a larger dose less frequently. But
the key is to average the same amount. For example, if your goal is
to average 0.5mg in your body, then you can take 0.5mg daily or
3.5mg weekly. Note
that while Avodart or Dutasteride has a long half-life, it does not
necessarily mean that the medication will simply stay fixed at the
highest "peak" level all the time.
DR.
LEE'S RESPONSE RE: PRESCRIBING AVODART FOR HAIR LOSS
October
10, 2002 post - This is from HairSite's
Dutasteride forum. Note that we have not verified if the email is
indeed from Dr. Richard Lee at Regrowth.
AVAILABILITY
& PRICE
Please read the anchored
topic
in the Avodart forum, availability and pricing is contantly updated
there.
GETTING
A SCRIPT
Someone has come across www.medicalwellnesscenter.com
which will write us a script for about $50. Many have already tried
their service. The beauty of this service is that we are NOT
obligated to purchase Avodart from any pharmacy. We can choose to
fill the script at ANY pharmacy of our choice. This site is
legitimate and if you want to read about posters' comments about
this website's service, please go to Avodart forum
35. Non U.S residents can take advantage of their service as
well.
AVODART
/ DUTASTERIDE
FORUM
AVODART™
IS INTENDED FOR THE TREATMENT OF BENIGN PROSTATE ENLARGEMENT. PLEASE
CHECK WITH YOUR DOCTOR IF HE WILL PRESCRIBE AVODART™
AS A HAIR LOSS TREATMENT. AVODART™
is a registered trademark of GlaxoSmithKline.
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