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PROSCAR is indicated for the treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms; reduce the risk of acute urinary retention (AUR); and reduce the risk of the need for surgery, including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed > 4-point increase in AUA symptom score).
Selected Safety Information
PROSCAR is contraindicated in patients who are hypersensitive to any component of this medication and in women when they are or may potentially be pregnant. PROSCAR is not indicated for use in pediatric patients or women.
Women should not handle crushed or broken tablets of PROSCAR when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.
Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain, or nipple discharge. Breast changes including breast enlargement, tenderness, and neoplasm have been reported.
Prior to initiating therapy with PROSCAR, appropriate evaluation should be performed to identify other conditions such as infection, prostate cancer, stricture disease, hypotonic bladder, or other neurogenic disorders that might mimic BPH.
In clinical studies, although an early improvement in urinary symptoms was seen in some patients, a therapeutic trial of at least 6 months was generally necessary to assess whether a beneficial response in symptom relief had been achieved.
Caution should be used in the administration of PROSCAR in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.
In the MTOPS study, there were 4 cases of breast cancer in men treated with finasteride (finasteride, 3; combination, 1) but no cases in men not treated with finasteride. During the 4-year, placebo-controlled PLESS study that enrolled 3,040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with finasteride. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9,060 had prostate needle biopsy data available for analysis. In the group treated with PROSCAR, 280 (6.4%) men had prostate cancer with Gleason scores of 7 to 10 detected on needle biopsy vs 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (Stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003;349:213-222) is provided for consideration by physicians when PROSCAR is used as indicated. PROSCAR is not approved to reduce the risk of developing prostate cancer.
In PLESS, a 4-year placebo-controlled study, 1,524 patients treated with PROSCAR and 1,516 patients treated with placebo were evaluated for safety. In this study the following clinical adverse reactions were reported as possibly, probably, or definitely drug related in > 1% of patients treated for 12 months with PROSCAR 5 mg/day or placebo, respectively: impotence (8.1%, 3.7%); decreased libido (6.4%, 3.4%); and decreased ejaculate volume (3.7%, 0.8%). Other drug-related adverse effects were ejaculation disorder (0.8%, 0.1%), breast enlargement (0.5%, 0.1%), and breast tenderness (0.4%, 0.1%).
Before prescribing PROSCAR, please read the Prescribing Information and Patient Product Information.
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