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. If you want the latest discussions, debates and developments about Avodart or Dutasteride, visit the hair loss 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 results.
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
Dutasteride for women

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 websites 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.   

DUTASTERIDE FOR WOMEN
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.

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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