1. PROPECIA HISTORY
How was Propecia discovered?

Propecia is a product of Merck & Co

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.

Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories.

Merck & Co. aims at helping to improve the health and well-being of people everywhere by discovering, developing and bringing to market breakthrough medicines. Their priorities are focused on turning cutting-edge science into breakthrough medicines that address significant unmet needs, and thus have the potential to become important medical advances.

Note: World-drugs.net sells generic version of Propecia

2.PROPECIA FACTS

Propecia is the first and only FDA-approved pill demonstrated to treat male pattern hair loss on the vertex (top of head) and anterior mid-scalp area (middle front of head) in men only.

3.ABOUT PROPECIA MEDICATION

Propecia prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH) and hair loss.

Propecia is used to reduce hair loss due to male pattern hair loss. Propecia is also used to treat benign prostatic hyperplasia (enlarged prostate).

Propecia may also be used for purposes other than those listed in this medication guide.

Male pattern hair loss is the most common form of hair loss, representing close to 95% of all cases of hair loss in men. And about half of all men experience male pattern hair loss by age 50.

It begins with a receding hairline and/or slow balding at the crown. It is typically a progressive condition—left untreated the hair loss will likely continue. Scientists believe male pattern hair loss is inherited from either side of your family and that a chemical called dihydrotestosterone, more commonly referred to as DHT, is a key factor in hair loss.

Causes of Hair Loss

Merck & Co. conducted the longest reported controlled clinical study of men with certain types of male pattern hair loss, 2 out of 3 men on Propecia regrew hair, as measured by actual hair counts over time. Whereas all men in the study taking a placebo (not Propecia) lost hair. The results were as shown below

4.PROPECIA EFFECTIVENESS
When is Propecia best taken?

The recommended dose of Propecia is 1 mg once a day.

Propecia 1 mg may be administered with or without meals.

In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.

 

Following an oral dose of Propecia 1 mg in man, a mean of 39% (range, 32-46%) of the dose was excreted in the urine in the form of metabolites; 57% (range, 51-64%) was excreted in the feces.

In a study in 15 healthy male subjects, the mean bioavailability (bioavailability is the extent to which a drug is absorbed and circulated in the body) of Propecia 1 mg tablets was 65%. In a separate study, the bioavailability of finasteride was not affected by food.

Approximately 90% of circulating Propecia 1 mg is bound to plasma proteins. Propecia 1 mg has been found to cross the blood-brain barrier.

Semen levels have been measured in 35 men taking Propecia 1 mg daily for 6 weeks. In 60% (21 of 35) of the samples, Propecia levels were undetectable. The mean Propecia level was 0.26 ng/mL and the highest level measured was 1.52 ng/mL.

The elimination rate of Propecia 1 mg decreases somewhat with age. Mean terminal half-life is approximately 5-6 hours in men 18-60 years of age and 8 hours in men more than 70 years of age. These findings are of no clinical significance, and a reduction in dosage in the elderly is not warranted.

No dosage adjustment is necessary in patients with renal insufficiency. Urinary excretion of Propecia metabolites was decreased in patients with renal impairment. This decrease was associated with an increase in fecal excretion of metabolites. Plasma concentrations of metabolites were significantly higher in patients with renal impairment. Furthermore, Propecia has been well tolerated in men with normal renal function receiving up to 80 mg/day for 12 weeks where exposure of these patients to metabolites would presumably be much greater.

5.PROPECIA EFFECTS ON SPECIAL POPULATION
How do different people react to Propecia?

Women who are or may potentially be pregnant must not use Propecia and should not handle crushed or broken Propecia tablets because the active ingredient may cause abnormalities of a male baby's sex organs. If a woman who is pregnant comes into contact with the active ingredient in Propecia, a doctor should be consulted. Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

6.PROPECIA EFFECTS ON MEDICAL CONDITIONS
How does Propecia affect your existing condition/ailment?

Before using this drug, tell your doctor your medical history, especially of: liver disease, prostate cancer, urinary tract disease, drug allergies. The drug can be absorbed through the skin.

7.OTHER/ALTERNATE USES OF PROPECIA
What else does Propecia treat?

Your doctor may perform blood tests or other forms of monitoring during treatment with Propecia. One of the tests that may be performed is called PSA (prostate-specific antigen). This test is used to help detect prostate cancer. Propecia will reduce the amount of PSA measured in the blood. Your doctor is aware of this effect and can still use PSA to help detect prostate cancer.

A study released by CNN indicates that Propecia used to treat male pattern baldness reduces the odds of getting prostate cancer by about 25 percent.

But there's some bad news: The same study seems to show that if a man taking Propecia does get the disease, the drug appears to increase his chance of getting a more aggressive form.

"Propecia is the first drug found to reduce the risk of prostate cancer," said Dr. Ian Thompson of the University of Texas Health Science Center at San Antonio, the study's lead author. " Propecia worked for men at low risk for prostate cancer, as well as those at high risk."

The National Cancer Institute estimates that if 1,000 63-year-old men were tracked, after seven years, 60 of them would develop prostate cancer, with 18 of those men suffering with high-grade tumors, which spread quickly.

If the same men took Propecia for seven years, only 45 would get the cancer, but 22 would have the more aggressive tumors.

A low-dose version of Propecia used to treat hair loss is marketed under the trade name Propecia, while under the name Proscar it's sold as a treatment for enlarged prostates.

In the study, which was funded by the National Cancer Institute and published in the online version of the New England Journal of Medicine, researchers at 221 sites nationwide followed nearly 19,000 men older than 55 for seven years.

About half of them were assigned at random to take either Propecia a drug that lowers male hormone levels, or a placebo.

By the end of the trial, those taking Propecia reduced their risk of prostate cancer by nearly 25 percent over those on placebos.

Mortality in both groups was the same: Five in each group died of prostate cancer.

8.ADVERSE/SIDE EFFECTS of PROPECIA
What are the side effects of Propecia?

In clinical studies for Propecia, a small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, or a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men and went away in men who stopped taking Propecia because of them.

Propecia is for the treatment of male pattern hair loss in men only and should not be used by women or children.

Propecia can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done, you should tell your doctor that you are taking Propecia.

Other side effects may include dry itching and flaking scalp and low blood pressure, which is completely reversible once stopping Propecia.

9. USEFUL SITES

http://www.merck.com/

http://www.fda.gov/

http://www.cnn.com

http://edition.cnn.com/2003/HEALTH/conditions/06/24/prostate.cancer.drug/