Finasterid

Proscar: zugelassen für

Zugelassene Anwendungsgebiete

• 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.

Darreichungsformen und Stärken

• 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.

Einnahme

• 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.

Darf nicht angewendet werden bei

• 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.

Wechselwirkungen

• 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)...

Warnhinweise und Vorsichtsmaßnahmen

• 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.

Häufige Nebenwirkungen

• The drug-related adverse reactions, reported in ≥1% in patients treated with PROSCAR and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash.

Schwangerschaft

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.

Wirkmechanismus

The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.

Zulassungsinhaber:

Organon LLC

Stand der Fachinformation:

18. März 2026

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