Generic Finasteride Proscar

Posted under Generic Finasteride Proscar

Generic Finasteride/Proscar/Propecia

Generic name(s):
Finasteride
Brand name(s):
Propecia, Proscar

What is the most important information I should know about finasteride?

Before taking finasteride, tell your doctor if you have ever had an allergic reaction to this medication, or to a similar medicine called finasteride (Propecia, Proscar). Finasteride should never be taken by a woman or a child. Finasteride can be absorbed through the skin, and women or children should not be permitted to handle finasteride tablets. Although finasteride is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Finasteride tablets should not be handled by a woman who is pregnant or who may become pregnant. If a woman accidentally comes into contact with this medication from a broken or crushed tablet, wash the area with soap and water right away. Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

What is finasteride?

Finasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Finasteride is used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Finasteride may also be used for other purposes not listed in this medication guide.

Proscar

Indications

PROSCAR is indicated for the treatment of symptomatic 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 benign prostatic hyperplasia (BPH) (a confirmed >4-point increase in American Urological Association [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.

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.

SCARP = Scandinavian Reduction of the Prostate Study
PROSPECT = PROscar Safety Plus Efficacy Canadian Two-year Study
PLESS = Proscar Long-Term Efficacy and Safety Study
PROWESS = Proscar Worldwide Efficacy and Safety Study
MTOPS = Medical Therapy of Prostatic Symptoms

PROSCAR is a registered trademark of MERCK & CO., Inc.

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