Finasteride Tablets

Overview of Finasteride Tablets

Dosage Strength

Commercial (Propecia®): 1 mg Tablets
Commercial (Proscar®): 5 mg Tablets
Commercial (Generic): 1 mg, 5 mg Tablets

General Information

A 5-alpha reductase inhibitor called finasteride is used to treat symptomatic benign prostatic hyperplasia (BPH), a condition that affects the majority of men over 50. In men with BPH, finasteride has been proven to raise and sustain the maximum urine flow rate, albeit fewer than 50% of men experience improvement despite a smaller prostate. A 50% decrease in serum PSA concentrations can be anticipated in a typical patient receiving finasteride treatment for BPH (>= 6 months); however, particular persons may see different PSA declines. Even when prostate cancer is present, serum PSA concentrations may decrease throughout treatment. Values should be increased for comparison with normal ranges in men who are not receiving treatment if doctors employ serum PSA concentrations as an assist in the identification of prostate cancer in men taking finasteride. Even though the number is within the normal range for untreated men, any increase from the starting point may indicate the presence of prostate cancer. No adjustments to PSA results appear to be required if doctors want to utilize percent free PSA (free to total PSA ratio) as a marker because finasteride does not appreciably lower the value. 1 The FDA warned medical professionals of the potential risk of an increased incidence of high-grade prostate cancer in patients receiving finasteride or dutasteride treatment in June 2011 after reviewing two sizable, randomized controlled trials, the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The PCPT trial’s findings revealed that men who received finasteride had a 26 percent lower overall chance of being diagnosed with prostate cancer compared to those who received a placebo (p 0.0001); however, the risk reduction was only applicable to tumors with a Gleason score (GS) of less than 6. Finasteride increased the risk of GS 8–10 prostate cancer compared to placebo (1.8 percent vs. 1.1 percent , respectively). 2 3 The efficacy of finasteride in treating bitemporal recession has not been established, but it has been shown to be effective for mild to severe hair loss of the vertex and anterior mid-scalp area. The FDA authorized finasteride (Proscar) for the treatment of BPH in June 1992. In December 1997, the FDA authorized Propecia, an additional oral finasteride dose form, for the management of male pattern baldness (i.e., androgenetic alopecia). Finasteride is also being tested as an alternate medication for the treatment of hirsutism.

References

1.Proscar (finasteride) package insert. Whitehouse Station, NJ: Merck and Co.; 2014 Jan.
2.Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003:349:213-22.
3.FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer. Retrieved June 9, 2011.
4.Kaplan SA, Holtgrewe HL, Bruskewitz R, et al. Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia. Urology 2001;57:1073-7.
5.Steiner JF. Clinical Pharmacokinetics and pharmacodynamics of finasteride. Clin Pharmacokinet 1996;30:16-27.
6.Propecia (finasteride) package insert. Whitehouse Station, NJ: Merck and Co., INC.; 2013 Sept.
7.Lee SJ, Park JB, Kim D,et al. In vitro selective inhibition of human UDP-glucuronosyltransferase (UGT) 1A4 by finasteride, and prediction of in vivo drug-drug interactions. Toxicol Lett. 2015;232:458-465.
8.McConnell JD, Bruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N Engl J Med 1998;338:557-63.
9.McConnell JD, Roehrborn CG, Bautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 2003;349:2387-98.
10.Robbers JE, Tyler VE. Tyler’s Herbs of Choice: the Therapeutic Use of Phytomedicinals. Binghamton, NY: Haworth Herbal Press, Inc.; 1999.
11.Marks LS, Hess DL, Dorey FJ, et al. Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens. Urology 2001;57:999-1005.
12.Aldercreutz H, Mazur W. Phyto-estrogens and western diseases. Ann Med 1997;29:95-120.
13.Samara EE, Hosmane B, Locke C, et al. Assessment of the pharmacokinetic-pharmacodynamic interaction between terazosin and finasteride. J Clin Pharmacol 1996;36:1169-78.
14.Vashi V, Chung M, Hilbert J, et al. Pharmacokinetic interaction between finasteride and terazosin, but not finasteride and doxazosin. J Clin Pharmacol 1998;38:1072-1076.

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