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WHAT IS FINASTERIDE?

Finasteride is a drug that was originally developed to treat an enlarged prostate condition called benign prostatic hyperplasia (BPH). It is made by Merck Pharmaceuticals under the brand name Proscar.

HOW DOES IT WORK?

Finasteride is a potent inhibitor of human 5-alpha-reductase, the enzyme in many tissues that converts Testosterone to Dihydrotestosterone (DHT). The androgens Testosterone and DHT control the development and function of the prostate gland and are believed to play a role in causing Androgenetic Alopecia, commonly referred to as Male Pattern Baldness. In tests on Proscar in the treatment of benign prostatic hyperplasia or BPH, the dose of 5 mg/day lowers serum DHT levels in men by 65-80% compared to baseline levels and decreases intraprostatic levels of DHT by 85% compared to placebo. The reductions of DHT are also noticed in the scalp where it has been shown that bald or balding men have much higher levels of DHT. Biopsies and biochemical analyses corroborate the elevated 5-alpha-reductase levels in the frontal scalp of balding men and the lack of hair loss in human males with extremely low levels of 5-alpha-reductase. This reduction of DHT in the scalp is believed to arrest the Androgenetic Alopecia, and in some instances actually reverse it.

EFFECTS ON THE BODY

A single 5 mg oral dose rapidly reduces serum DHT concentrations by as much as 70%, with the maximum reduction occurring at about 8 hours. The effect lasts for at least 24 hours, so once daily dosing is appropriate. Actual clinical effects, however, are not realized for 3-6 months after beginning therapy. The bio availability following a single dose of Finasteride is only 63%, and the presence of food further decreases oral absorption.

INDICATIONS

PROPECIA? is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. PROPECIA? is not indicated for use in women or children.

DOSAGE AND ADMINISTRATION

The recommended dosage is one 1 mg tablet daily. PROPECIA? may be taken with or without food. In general, daily use for 3 months or more is necessary before increased hair growth and/or prevention of further hair loss is observed. Continued use is recommended to obtain maximum benefit.

CONTRAINDICATIONS

PROPECIA? is contraindicated in the following: Use in women when they are or may potentially be pregnant (See Pregnancy) Hypersensitivity to any component of this product. PROPECIA? is not indicated for use in women or children. PRECAUTIONS In clinical studies with PROPECIA? in men 18-41 years of age, the mean value of serum prostate specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. When PROPECIA? is used for treatment of male pattern hair loss in older men who also have benign prostatic hyperplasia (BPH), consideration should be given to the fact that, in older men with BPH, PSA levels are decreased by approximately 50%.

PREGNANCY

PROPECIA? is contraindicated for use in women when they are or may potentially be pregnant. Because of the ability of Type ll 5a-reductase inhibitors to inhibit conversion of testosterone to DHT in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman. Crushed or broken tablets of PROPECIA? should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. Whole tablets are coated to prevent contact with the active ingredient during normal handling.

DRUG INTERACTIONS

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolising enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, glyburide, propranolol, theophylline, and warfarin and no interactions were found. Although specific interaction studies were not performed, in clinical studies finasteride doses of 1 mg or more were used concomitantly with ACE inhibitors, acetaminophen, alpha blockers, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (NSAIDs), and quinolones, without evidence of clinically significant adverse interactions.

SIDE EFFECTS

PROPECIA? is generally well tolerated. Side effects, which usually have been mild, generally have not required discontinuation of therapy. Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 men. In three 12-month, placebo-controlled, double-blind, multicentre studies of comparable design, the overall safety profiles of PROPECIA? and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 1.7% of 945 men treated with PROPECIA? and 2.1 % of 934 men treated with placebo. In these studies, the following drug-related adverse experiences were reported in >1 % of men treated with PROPECIA?: decreased libido (PROPECIA?, 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with PROPECIA? and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with PROPECIA? and in many who continued therapy.

AVAILABILITY

PROPECIA? is available in packs of 28 tablets.