Finasteride

Propecia

• PROPECIA ® is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
• Efficacy in bitemporal recession has not been established.
• PROPECIA is not indicated for use in women.
• PROPECIA is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.

Proscar

• PROSCAR, is a 5α-reductase inhibitor, 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 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 American Urological Association (AUA) symptom score).
• Limitations of Use: PROSCAR is not approved for the prevention of prostate cancer.

Propecia

PROPECIA tablets (1 mg) are tan, octagonal, film-coated convex tablets with "stylized P" logo on one side and PROPECIA on the other. 1 mg tablets.

Proscar

5-mg blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and PROSCAR on the other. 5-mg film-coated tablets.

Propecia

• PROPECIA may be administered with or without meals.
• The recommended dose of PROPECIA is one tablet (1 mg) taken once daily.
• In general, daily use for three months or more is necessary before benefit is observed.
• Continued use is recommended to sustain benefit, which should be re-evaluated periodically.

Proscar

• PROSCAR may be administered with or without meals.
• Monotherapy: One tablet (5 mg) taken once a day.
• Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin.

Propecia

• most common adverse reactions, reported in ≥1% of patients treated with PROPECIA and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder.
• the most frequently reported adverse reactions. Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo over the 4 years of the study.

Proscar

• The most frequently reported adverse reactions were related to sexual function. 3.7% (57 patients) treated with PROSCAR and 2.
• the most frequently reported adverse reactions. Table 1 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo over the 4 years of the study.

Propecia

• PROPECIA is not indicated for use in women or pediatric patients.
• Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus.
• PROPECIA causes a decrease in serum PSA levels.
• Any confirmed increase in PSA while on PROPECIA may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor. 5α-reductase inhibitors may increase the risk of high-grade prostate cancer.

Proscar

• PROSCAR reduces serum prostate specific antigen (PSA) levels by approximately 50%.
• However, any confirmed increase in PSA while on PROSCAR may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor.
• PROSCAR may increase the risk of high-grade prostate cancer.
• Females should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus.

Propecia

• PROPECIA is contraindicated in the following: Pregnancy.
• Finasteride use is contraindicated in women when they are or may potentially be pregnant.
• Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride.
• If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Proscar

• PROSCAR is contraindicated in the following: Hypersensitivity to any component of this medication.
• Finasteride use is contraindicated in females when they are or may potentially be pregnant.
• Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride.
• If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Propecia

• Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified.
• Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system.
• Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. Other Concomitant Therapy Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics,...

Proscar

• Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified.
• Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system.
• Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. Other Concomitant Therapy Although specific interaction studies were not performed, PROSCAR was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE)...

Propecia

Pregnancy Category X. PROPECIA is contraindicated for use in women who are or may become pregnant. PROPECIA is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.

Proscar

PROSCAR is contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, PROSCAR may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female.