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. If you want the
latest discussions, debates and developments about Avodart or
Dutasteride, visit the
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
Avodart (dutasteride) hair loss survey
What is Avodart or Dutasteride?
Side effects, warnings,
Optimal dose for
Administration with or
Half-life and dosing
Availability and pricing information
Getting a script
results as of Jan 9th, 2003
Dutasteride for women
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
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.
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.
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
for a more thorough discussion about topical dutasteride:
would be great because of the absence of side effects, but I
have always wondered about the efficacy of topical alpha-5
reductase inhibitors. Granted there is evidence that DHT is
manufactured in the scalp and hair follicle, and this no
doubt contibutes to the damage, but what about DHT
manufactured elsewhere and carried to the hair via the
opinion, serum DHT *does* have an effect on hair follicles,
but it's a relatively minor one compared to the effect of
the DHT that's manufactured right there inside the
Why do I
believe that? Mainly because of some very convincing animal
evidence: topical 5a-reductase inhibitors have a VERY potent
effect in standard animal models like the hamster
flank-organ and ear pinna. Indeed, those topical substances
that have no systemic effect whatsoever are able to produce
nearly castration-like effects in the animals' sebaceous
glands (hair follicles, too, apparently) where they're
applied. So what happens when you try to make your very same
argument about the animals?? The animals' sebaceous glands
are exquisitely sensitive to the effects of androgens (and
DHT in particular), too, and yet they shrink right up when
you apply topical 5a-reductase inhibitors to them! That
proves that locally-produced DHT is more important than
serum DHT, at the very least in those animals; and there's
no particular reason not to think that the same is true in
humans. In fact, I can cite a *human* study where the
researchers concluded that sebaceous glands are not
responsive to serum DHT.
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
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.
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
SIDE EFFECTS, WARNINGS,
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
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
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.
Also, please note the effect of Avodart on serum DHT
vs scalp DHT.
0.5mg Dutasteride inhibits ~ 92% serum DHT and 55%
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 Dutasteride "Optimal Daily Dose". Also, another
dutasteride dose discussion and charts put together by Boris.
OR WITHOUT FOOD
Please read Bryan's interpretation about whether Avodart should be taken
with or without food:
|Re: Bryan or anyone, what
does this mean, in plain simple English...
Time: 5:58:44 PM
Remote Name: 18.104.22.168
"Following administration of a single 0.5 mg dose of a soft
gelatin capsule, time to peak serum concentrations of
dutasteride occurs within 2 to 3 hours. Absolute
bioavailability in five healthy subjects is approximately
60% (range 40% to 94%). When the drug is administered with
food, the maximum serum concentrations were reduced by 10%
to 15%. This reduction is of no clinical significance."
>>What are they saying here ??? Does it mean that if we take
dutasteride with food, the medication will remain in our
body longer? Even though they say there is no clinical
significance, would it be better to have the medication in
our body 10-15% longer ?<<
No, I think they're clearly saying that less of the drug is
absorbed (or "bioavailable") when taken along with food. For
just a second or two I also wondered (as you seemed to do)
if they meant that the absorption of the drug is merely
SLOWED DOWN for a while but still eventually gets absorbed;
however, the fact that it has such a long half-life and yet
the peak levels in the blood are still reduced strongly
suggests to me that there's that extra percentage of it that
never does get absorbed, when it's taken with food.
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).
15-30 degrees Celsius or 59 - 86 degrees F.
Discussions here about
half-life are mostly courtesy of Bryan in Dutasteride Forum.
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.
New study suggests that dutasteride might be effective for women
with hair loss. Journal of Drugs in Dermatology, Sept-Oct, 2005 by
Malgorzata Olszewska, Lidia Rudnicka: " After 6 months of therapy,
significant improvement was observed and after 9 months the clinical
diagnosis of androgenic alopecia could no longer be made in this
patient. No side effects were observed. In conclusion, theoretical data
and our experience in this case show that dutasteride might develop into
a true alternative in treatment of androgenic alopecia."
Click here for details.
hair loss drugs 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.
Questions, please email HairSite@aol.com