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White or off-white crystalline solid
DMSO: 32 mg/mL, soluble
Store at RT
Medical uses Benign prostatic hyperplasia
Physicians use finasteride for the treatment of benign prostatic hyperplasia (BPH), informally known as an enlarged prostate. The FDA-approved dose is 5 mg once a day. Six months or more of treatment with finasteride may be required to determine the therapeutic results of treatment. If the drug is discontinued, any therapeutic benefits reverse within about 6–8 months. Finasteride may improve the symptoms associated with BPH such as difficulty urinating, getting up during the night to urinate, hesitation at the start of urination, and decreased urinary flow.
Finasteride is sometimes used in hormone replacement therapy for male-to-female transsexuals in combination with a form of estrogen due to its antiandrogen properties. However, little clinical research of finasteride use for this purpose has been conducted and evidence of efficacy is limited. Indeed, finasteride is a substantially weaker antiandrogen in comparison to conventional antiandrogens like spironolactone and cyproterone acetate. Finasteride has also been found to mitigate the effects of withdrawal after chronic alcohol use.
In a four year controlled clinical study, 3040 patients with symptomatic benign prostatic hyperplasia were treated with 5 mg per day finasteride or placebo. Discontinuation rates due to adverse reactions related to sexual function were 3.7% in the finasteride arm and 2.1% in the placebo arm. Sexual effects were the most common type of adverse reaction.
In 12 month duration double-blind clinical trials including more than 3000 patients, adverse effects included decreased libido (5% in the finasteride group and 3% in the placebo group), erectile dysfunction (8% finasteride, 3% placebo), and ejaculation disorder (2% finasteride, 0.6% placebo).
Anxiety and depression
Mood disorders were not observed as an important adverse effect in the phase 3 trials leading to regulatory approval of finasteride for the treatment of benign prostatic hyperplasia.Nonetheless, regulatory authorities have listed mood disorders as among the possible adverse effects of finasteride, and a variety of small studies have suggested a possible connection.
In a small study examining the use of finasteride to treat hirsutism in women, fewer patients in the finasteride-treated group reported depression relative to the control group.
Another study with a larger sample size of 128 men, though no women, also at a dose of 1 mg per day, found that finasteride increased both BDI and HADS depression scores significantly. The authors concluded that finasteride should be prescribed cautiously to patients at a high risk of depression.
A study comparing depression in impotent men with a history of exposure to finasteride found that they experienced greater depression and suicidal ideation relative to non-impotent men without a history of finasteride exposure. The authors did not comment on the relative extent to which sexual dysfunction and prior finasteride treatment might have contributed to the depression.
Male breast cancer
In December 2009, the Medicines and Healthcare products Regulatory Agency in theUKannounced new drug safety advice on finasteride and the potential risk of male breast cancer. The agency concluded that, although overall incidence of male breast cancer in clinical trials for finasteride 5 mg was not significantly increased, a higher risk of male breast cancer with finasteride use cannot be excluded. A warning on this risk will be included in the product information. Merck revised the United States' warning in consumer and medical leaflets to include the risk of male breast cancer.
Finasteride is in the FDA pregnancy category X. This means that it is known to cause birth defects in a fetus. Women who are or who may become pregnant must not handle crushed or broken finasteride tablets, because the medication could be absorbed through the skin. Finasteride is known to cause birth defects in a developing male baby. Exposure to whole tablets should be avoided whenever possible, however exposure to whole tablets is not expected to be harmful as long as the tablets are not swallowed. It is not known whether finasteride passes into breast milk, and thus should not be taken by breastfeeding women. Finasteride may pass into the semen of men, but Merck states that a pregnant woman's contact with the semen of a man taking finasteride is not an issue for concern. Finasteride is known to affect blood donations, and potential donors are typically restricted for at least a month after their most recent dose.
Interference with doping assays
Many sports organizations have banned finasteride because it can be used to mask steroid abuse.Since 2005, finasteride has been on the World Anti-Doping Agency's list of banned substances. However, it was removed from the list in 2009. Notable athletes who used finasteride for hair loss and were banned from international competition include skeleton racer Zach Lund, bobsledder Sebastien Gattuso, footballer Romário and ice hockey goaltender José Théodore.
Category: Endocrine Drugs API