Systemic therapy: Finasteride
Medicinal Systemic Therapy    Includes finasteride and the anti-androgens, mainly cyproterone acetate. FINASTERIDE (PROPECIA) - Updates In 1997, the FDA approved the use of finasteride at a dosage of 1 mg per day for males suffering from androgenetic alopecia. It has been available in Spain since 1999. Mode of action: Finasteride is a synthetic analogue of testosterone which acts in competition as the predominant inhibitor of 5-alfa-reductase, type 2, which is an intracellular enzyme that converts testosterone into dihydrotestosterone (DHT), a potent androgen responsible for the progressive miniaturization hair follicles. Its specificity is caused by its extreme affinity for the type 2 isoenzyme over the type 1. By inhibiting this enzyme, the conversion of testosterone into dihydrotestosterone is blocked, producing significant reductions in the levels of DHT in fluids and tissues. It has been demonstrated that the preferred location of the type 2 iso-enzyme in the scalp is in the hair follicle, over the type 1 iso-enzyme, which is predominantly located in the sebaceous glands. This explains its specificity of action on hair loss. Dosage: Finasteride is administered orally in a 1 mg/day tablet which, as stated earlier, is the FDA approved dosage for the treatment of androgenetic alopecia. It can be taken at any time of the day, with or without food, and it hasn't shown any significant interactions with other medications. Daily administering of the drug produces an accumulation of levels in the blood which reach a certain stable concentration necessary for it to take effect. This is produced approximately between the third and fourth month since beginning the treatment (this is when it begins to affect the hair and side- or adverse-effects begin, if any) and is maintained as long as the patient continues taking the medication. If the patient forgets to take a tablet, the level of medication in the blood doesn´t abruptly drop, so that the next day the dosage can be resumed without having to take two tablets together. If the patient stops taking finasteride (whatever the reason may be) the concentration of the drug in the blood decreases and disappears completely between the second and third month. This means that it still has an effect during this period in spite of there being no more tablets administered. Propecia, the commercial name for finasteride in 1 mg tablets, is currently the only brand registered and authorized for the treatment of androgenetic alopecia. On that premise, and independently of the industrial and commercial property rights over the active ingredients, Proscar broken up into smaller fragments (5 mg tablets of finasteride) or any other variety of finasteride (capsules, medications prepared by the pharmacy, etc.) which are used for the same purpose should also be interchangeable with the Propecia 1 mg tablets. On one hand, there are issues of ethics, legality, variability in dosage and security which accompany the breaking up of Proscar tablets. On the other, there are advantages such as deregulation and availability of finasteride apart from the commercially distributed tablets. Adverse side effects: The adverse side effects observed in finasteride are produced in the fourth month since taking the medicine and are reversible two or three months after suspension of treatment, when it has been completely eliminate from the blood. A study which was published in an important scientific journal, The European Journal of Dermatology in 2002, titled "Long-term (5 years) Multinational Experience of finasteride 1 mg in the treatment of males with androgenetic alopecia" shows results obtained from the comparison of a population of 1553 males with AGA who were randomly divided into two groups and were administered finasteride 1mg/day to one group and a placebo (tablet composed of excipients only without any effect) to the other group. The effects uncovered were seen in less than 1% of participants and are summarized in the following list: Reduction of the libido (1.8% in the finasteride group and 1.3% in the placebo group during the first year. In the fifth year these figures became 0.3 vs. 0 respectively). Erectile dysfunction (1.4% against 0.6% after a year and 0.3 vs. 0 respectively in the fifth year) Reduction in the volume ejaculated (1.4% against 0.9% which in the fifth year became 0% in both groups). Very infrequently there have been published cases of gynecomoastia, testicular pain and hypersensitive reactions to a 1 mg dosis of finasteride which were reversible on suspension of drug. When considered separately, there was no significant difference in adverse effects in the placebo group but there was when they are considered globally, 3.9% (finasteride group) versus 2.4 % (placebo group). The adverse effects simultaneously reduce during the months after in 58% of those who continue the treatment, they are completely reversible after suspension of the drug. A recent study confirmed that a 1 mg daily dosis of finasteride taken during 48 weeks does not affect spermatogenesis or production of sperm 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 carried out by the American Urological Association on "Recommendations for  the prophylactic use of finasteride against prostate cancer" demonstrated that finasteride in dosages of 5 and 1 mg reduce the size of the prostate, the levels of PSA (prostate specific antigen used to detect cancer in the prostate) and DHT. So while it can´t be said that finasteride 1 mg eliminates the risk of cancer, it does reduce its occurrence. It´s not necessary for any specific laboratory test, but it is feasible to ask for a base analysis before prescribing the medication. In this way, previous changes can be detected, which if done later couldn´t be attributed to the drug. Use in women - Teratogenicide: Even though the FDA has not yet approved the use of finasteride in women, there are studies looking at the use of finasteride in women who suffer from androgenetic alopecia. Several studies have shown that finasteride 1 mg/day gave no results whereas the use of 2.5 to 5 mg/day showed more encouraging results. An example of this can be seen in a study performed by Lorizzo et al. in which there was an improvement in the alopecia in 23 out of 27 women in pre-menopause (associated with an ant conceptive composed of drospirenona and ethinly estradiol).  Another study was presented by Trueb (5 post-menopausal women treated with 2.5 or 5 mg finasteride) which showed positive results. These are only examples but there is still a long way to go and much research to do. Finasteride is categorized as X for pregnant women, as being an anti-androgen means that it can feminize a masculine fetus.  Its use in women of fertile age is strictly forbidden unless they are using anti-conceptive measures. Women of fertile age not only shouldn´t take finasteride nor should they touch broken or squashed tablets.  Nevertheless, unless there is a breakage in the women's skin, significant percutaneous absorption is unlikely to occur. Finasteride tablets have an impermeable coating which prevents contact with the active ingredients during handling. In theory there is a risk, although highly improbable, of deformations of the sexual organs of the masculine fetus if the couple have sexual relations during the stages of pregnancy when the sexual organs of the fetus are developing (in the 8th and 15th week of gestation). That said the quantity of the drug found in semen is very small and considered to be insufficient to cause any damage to the masculine fetus. A report from a laboratory that fabricates finasteride stated that they measured the concentrations in semen of 35 males who were taking 1 mg per day of finasteride during 6 weeks. In 60% of the samples (21 of 35) they could not detect any finasteride. Therefore, when using finasteride, only a very very small part of it goes to the semen. However, even if it weren´t so low, it still wouldn´t cause any problems. The transfer of finasteride, from semen to the women through the vaginal wall was not detected in the many examinations performed to date. The risk of teratogenicide in humans has not been evaluated, only in experimental animals, in which abnormalities were caused in the urogenital system. To date there are no studies which evaluate if the oral ingestion of semen of a person taking finasteride by a pregnant woman gives rise to sufficient absorption via the intestine to cause any effect on the fetus. Lactation: finasteride is not recommended for women during the lactation period. It is not known if finasteride is excreted in mother's milk.
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Dr. José Lorenzo - Dra. Ximena Vila
Advanced Hair Transplant Clinic PIONEERS IN SPAIN Year 2003 FUE TECHNIQUE Table III.   Clinical adverse effects related with the medicine in 1% or more of patients. Year 1 Year 2 Year 3 Year 5 Year 4 Fin Pbo Fin Pbo Fin Pbo Fin Pbo Fin Pbo (N=779) (N=774) (N=547) (N=60) (N=447) (N=46) (N=379) (N=33) (N=323) (N=23) 34(4,4) 17(2,2) 9(1,6) 1(1,7) 4(0,9) 4(1,1) 0 0 2(0,6) 0 11(1,4) 8(1,0) 4(0,7) 0 0 0 0 0 2(0,4) 1(0,3) 15(1,9) 10(1,3) 7(1,3) 1(1,7) 1(0,2) 2(0,5) 1(0,3) 0 0 0 11(1,4) 7(0,9) 2(0,4) 0 2(0,4) 1(0,3) 0 0 0 0 11(1,4) 5(0,6) 4(0,7) 0 1(0,2) 1(0,3) 0 0 0 1(0,3) Total number (%) of patients  with sexual adverse effects  related to the drug  Total number (%) of patients  who stopped using the drug due to  related sexual adverse effects.   Most often seen adverse effect related to the drug (%) Reduction of libido Ejaculation disorder Erectile dysfunction