Systemic treatment Finasteride

n 1997, the FDA approved finasteride at a dose of 1 mg per day for men with androgenetic alopecia. In Spain it has been marketed since 1999.

Mechanism of action:
Finasteride is a synthetic testosterone analog that acts competitively as a predominant inhibitor of 5 alpha reductase type 2, an intracellular enzyme that converts testosterone into dihydrotestosterone (DHT), a potent androgen responsible for influencing the hair follicle in the progressive miniaturization of the hair. Its specificity is based on the high affinity it has for the type 2 isoenzyme, compared to type 1. By inhibiting this enzyme, the conversion of testosterone to dihydrotestosterone is blocked, producing significant reductions in DHT levels in serum and tissues. It has been possible to verify that the preferential location of the type 2 isoenzyme in the scalp is in the hair follicle, compared to the type 1 isozyme, which is located predominantly in the sebaceous glands,

Dosage:
The drug is taken orally in 1mg / day tablets, FDA approved dosage as mentioned at the beginning for the treatment of androgenetic alopecia. It can be taken at any time of the day, with or without food, and no significant interactions with other medications have been shown. Daily administration produces an accumulation of drug levels in the blood until reaching a stable concentration necessary to achieve its effect. This occurs approximately the third-fourth month after starting the treatment (it is then when effects on the hair and secondary or adverse effects if any) begin to be perceived and it is maintained as long as the medication is continued. If you miss a feeding the blood levels do not drop abruptly, so that the next day you continue taking the pill without doubling the dose (that is, 2 tablets together). If the administration of finasteride is discontinued (whatever the cause) the concentration in the blood is completely eliminated between the second and third month, that is, it would continue to have an effect during that period of time despite not taking the tablets.

Currently Propecia, the brand name of finasteride in 1 mg tablets, is the only authorized trademark for the treatment of androgenic alopecia. With this premise, and regardless of the industrial and commercial property rights of the active principle, both the Proscar fractions (5 mg finasteride tablets) and any type of finasteride formulation (capsules, pharmacy preparations, etc.) that are could be used for this purpose should be shown to be interchangeable with Propecia 1 mg tablets. There are ethical, legal, variability and safety issues that accompany the fractionation of Proscar tablets on the one hand, and those related to the release and availability of finasteride from independently marketed capsules, on the other.

Adverse effects:
The adverse effects observed after the use of finasteride occur from the fourth month after the start of the medication and are reversible when it is discontinued after about 2-3 months, after its complete elimination in the blood.

A study published in a leading scientific journal, the 2002 Eupopean Journal of Dermatology, entitled “Long-term multinational experience (5 years) with finasteride 1 mg in the treatment of men with androgenetic alopecia” shows results obtained after comparing a population of 1553 men with AGA who were randomly divided into 2 groups and administered finasteride 1mg / day or placebo (tablet composed only of excipients, that is, without any effect).

The effects found were seen in at least 1% of the participants and are summarized in the following list:

Decreased libido (1.8% in the finasteride group versus 1.3% in those treated with placebo during the first year, at the fifth year the figures were 0.3 vs. 0 respectively),
Erectile dysfunction (1.4% versus 0.6% per year and 0.3 versus 0 respectively at the fifth year),
Decrease in ejaculate volume (1.4% compared to 0.9%, which in the fifth year equaled 0% in both groups).

Gynecomastia, testicular pain, hypersensitivity reactions to doses of 1 mg of finasteride that were reversible with discontinuation of the drug have been reported very infrequently. There was no significant difference from the placebo group for each of the adverse effects alone, but there were when considering them overall 3.9% (finasteride group) versus 2.4% (placebo group).

The adverse effects spontaneously decrease in the following months in 58% of those who decide to continue the treatment, they are totally reversible after stopping the drug. A recent study confirmed that 1 mg of finasteride daily for 48 weeks does not affect spermatogenesis or sperm production in males between the ages of 19 and 41.

Long-term effects are still unknown, although there are no known systemic adverse effects. A study by the American Urological Association on “Recommendations regarding the prophylactic use of finasteride for prostate cancer” showed that both finasteride in doses of 5 and 1 mg reduce prostate size, levels of PSA (prostate specific antigen measured by urologists to detect prostate cancer) and DHT; and while 1 mg finasteride cannot be said to eliminate cancer risk if it reduces its clinical incidence.

There is no need to control any laboratory parameter, but it is advisable to request a baseline analysis before prescribing the drug. In this way, previous alterations can be detected, which later cannot be attributed to the drug.

Use in women – Teratogenicity:
Finasteride is not yet approved by the FDA for use in women, however, for all those with a pattern of androgenetic alopecia, its use is under study. Several studies carried out using finasteride 1mg / day did not show results, on the other hand, the use of doses of 2.5 to 5mg / day seems to have more encouraging results. An example of this is a study conducted by Iorizzo et al. in which it demonstrated improvement of alopecia in 23 of 27 premenopausal women (associated with a contraceptive composed of drosperidone and ethinyl estradiol). Another work was presented by Trueb (5 postmenopausal women treated with 2.5 or 5 mg of finasteride) with positive results. These are just examples but there is still a long way to go and studies to be done.

Finasteride is within category X for pregnancy, being an antiandrogen it has the ability to cause feminization in a male fetus. Its use is strictly contraindicated in women of childbearing age unless they use safe contraceptive measures. Women of childbearing age should not only not take finasteride but also should not handle broken or crushed tablets. However, unless there is an abnormality-disruption of the skin barrier in the woman, significant percutaneous absorption is unlikely. Finasteride tablets have a waterproof layer that covers them to prevent contact with the active ingredients during handling. There is a theoretical risk, although very unlikely, of malformations of the sexual organs of the male fetus if the couple has sexual intercourse during the stage of pregnancy when the sexual organs are developing (at 8 and 15 weeks of gestation). However, the amount of the drug found in semen is very small and is considered not enough to harm the male fetus. A manufacturing laboratory reports that semen concentrations were measured in 35 men who were taking 1 mg finasteride daily for 6 weeks. In 60% of the samples (21 of 35) the concentrations of finasteride could not be detected. the amount of the drug found in semen is very small and is not considered to be enough to harm the male fetus. A manufacturing laboratory reports that semen concentrations were measured in 35 men who were taking 1 mg finasteride daily for 6 weeks. In 60% of the samples (21 of 35) the concentrations of finasteride could not be detected. the amount of the drug found in semen is very small and is not considered to be enough to harm the male fetus. A manufacturing laboratory reports that semen concentrations were measured in 35 men who were taking 1 mg finasteride daily for 6 weeks. In 60% of the samples (21 of 35) the concentrations of finasteride could not be detected.

Therefore, when finasteride is used, a very, very small part goes into the semen. However, even if it were not, it would not cause problems. The transfer of finasteride, from the semen to the woman through the vaginal wall was not detected in the exhaustive examinations carried out so far. The risk of teratogenicity in humans has not been evaluated, but in experimental animals, in which it causes abnormalities of the genitourinary system. There are no studies to date that have evaluated whether oral ingestion of semen from a patient receiving finasteride results in sufficient intestinal absorption in a pregnant woman to cause any effect on the fetus.

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