Finasteride - Generic Propecia

A 5-year clinical study demonstrated the effectiveness of PROPECIA.

• 9 of 10 men on PROPECIA had visible results (either regrowth of hair, 48% [134 of 279], or no further hair loss, 42% [117 of 279]) vs 25% (4 of 16) on placebo (sugar pill), according to an assessment of photographs by an independent panel of dermatologists.
• 2 of 3 men who took PROPECIA regrew hair, as measured by hair count. All the men in the study who were not taking PROPECIA lost hair.
• A majority of men who took PROPECIA were rated as improved by doctors—77% (210 of 271) vs 15% (2 of 13) with placebo.
• A majority of men who took PROPECIA reported their bald spot getting smaller, their hair loss slowing down, and the appearance of their hair improving.

What’s more, in the first year of the study, 86% (587 of 679) of men who took PROPECIA maintained hair or increased the number of visible hairs vs 42% (282 of 672) who took placebo.

PROPECIA is for MEN ONLY.

Further treatment is unlikely to help if the drug has not worked within 12 months. If you stop taking PROPECIA, you will likely lose the hair you have gained within 12 months of stopping treatment.

Five years of clinical data with PROPECIA show the sooner you start, the better.

If you have MPHL, the sooner you get started on PROPECIA, the more hair you may have later. In fact, in the longest reported controlled study of male pattern hair loss ever conducted, men who were treated with a placebo (sugar pill) and then switched to PROPECIA 1 year later never caught up to the men who took PROPECIA for the full 5 years.

If you stop taking PROPECIA, you will likely lose the hair you have gained within 12 months of stopping treatment.

In the first year of the study, 86% (584 of 679) of the men on PROPECIA maintained hair or increased the number of visible hairs vs 42% (282 of 672) of the men on placebo.

PROPECIA is the first and only FDA-approved pill used for the treatment of male pattern hair loss on the vertex (top of head) and anterior mid-scalp area (middle front of head). There is not sufficient evidence that PROPECIA works for receding hairlines at the temples. PROPECIA is for use by MEN ONLY and should NOT be used by women or children.

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.

Good for you! You’ve already taken a positive step to fight your male pattern hair loss.

A few points to keep in mind:

• Remembering to take your pill each day is important.
• PROPECIA will not work faster or better if you take it more than once a day.
• If you forget to take PROPECIA, do not take an extra tablet. Just take the next tablet as usual.

The promise is simple. Use PROPECIA for 12 months. If you don’t at least maintain the hair you had when you began treatment, we’ll give you a full refund of your purchase price, less any rebates you received.

This program is for new male patients aged 18 or older with male pattern hair loss who continue to use PROPECIA for 12 months.

Finasteride is a competitive and specific inhibitor of Type II 5 alpha-reductase, an intracellular enzyme that converts the androgen testosterone into dihydrotestosterone (DHT). Two distinct isozymes of 5 alpha-reductase are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5 alpha-reductase is predominant in the sebaceous glands of most regions of skin, including scalp and liver. Type I 5 alpha-reductase is responsible for approximately one-third of circulating DHT. The Type II 5 alpha-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.

In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type II isozyme. Using native tissues (scalp and prostate), in vitro binding studies examining the potential of finasteride to inhibit either isozyme revealed a 100-fold selectivity for the human Type II 5 alpha-reductase over Type I isozyme (IC 50=500 and 4.2 nM for Type I and II, respectively). For both isozymes, the inhibition by finasteride is accompanied by reduction of the inhibitor to dihydrofinasteride and adduct formation with NADP +. The turnover for the enzyme complex is slow (t 1Ä2 approximately 30 days for the Type II enzyme complex and 14 days for the Type I complex).

Finasteride has no affinity for the androgen receptor and has no androgenic, antiandrogenic, estrogenic, antiestrogenic, or progestational effects. Inhibition of Type II 5 alpha-reductase blocks the peripheral conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations. Finasteride produces a rapid reduction in serum DHT concentration, reaching 65% suppression within 24 hours of oral dosing with a 1 mg tablet.

In men with male pattern hair loss (androgenetic alopecia), the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp. Administration of finasteride decreases scalp and serum DHT concentrations in these men. By this mechanism, finasteride interrupts a key factor in the development of androgenetic alopecia in those patients genetically predisposed.

In a study in 15 healthy male subjects, the mean bioavailability of finasteride 1 mg tablets was 65% (range, 26 to 170%), based on the ratio of AUC relative to a 5 mg i.v. dose infused over 60 minutes. Following the i.v. infusion, mean plasma clearance was 165 mL/min (range, 70 to 279 mL/min) and mean steady-state volume of distribution was 76 L (range, 44 to 96 L). In a separate study, the bioavailability of finasteride was not affected by food.

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

PROPECIA is for the treatment of male pattern hair loss in MEN ONLY. Further, women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken tablets of PROPECIA because it may cause abnormalities of a male baby’s sex organs. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling.

• If you are buying Propecia for the first time, start with a small amount to make sure that Propecia works for you and then order more later.
• If you have been taking Propecia for a while and will continue to take it regularly, buy as much Propecia as you can at once. Most online pharmacies offer discounted prices when you buy Propecia in large quantities. Plus, you won’t have to worry about refills for a while.
• Remember to consider the total cost of your Propecia order when you compare Propecia prices, including any doctor consultation fees and delivery charges.

Based on vertex studies at 24 months of men 18 to 41 with mild to moderate hair loss, the clinical results of PROPECIA are impressive:

83% maintained their hair based on hair count (vs. 28% with placebo), 66% had visible regrowth as rated by independent dermatologists (vs. 7% with placebo), 80% were rated as improved by clinical doctors (vs. 47% with placebo), and most men reported an increase in the amount of hair, a decrease in hair loss, and improvement in appearance.

Only a doctor can determine if PROPECIA is right for you. PROPECIA is for men only. Further, women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken tablets because it may cause abnormalities of a male baby’s sex organs. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling.

You may need to take PROPECIA daily for 3 months or more to see visible results. PROPECIA may not regrow all your hair. And if you stop using this product, you will gradually lose the hair you have gained. There is not sufficient evidence that PROPECIA works for recession at the temporal areas. If you haven’t seen results after 12 months of using PROPECIA, further treatment is unlikely to be of benefit.

Like all prescription products, PROPECIA may cause side effects. In clinical studies, a very small number of men experienced certain side effects, such as: less desire for sex, difficulty in achieving an erection, and a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men. These side effects were reversible and went away in men who stopped taking the PROPECIA. They also disappeared in most men (58%) who continued taking PROPECIA.

Taken once a day in tablet form, PROPECIA is simple, easy, and -most important- clinically demonstrated to be effective in most men. PROPECIA helps grow natural hair not just “peach fuzz” and is as convenient to take as a vitamin: one pill a day.

• 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.

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

• Propecia may also be used for purposes other than those listed here.

• Take Propecia exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Propecia can be taken with or without food.
• It is important to take Propecia regularly to get the most benefit.
• 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.
• Store this medication at room temperature away from moisture and heat.