Proscar

Monotherapy

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
  • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy .

Combination With Alpha-Blocker

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 .

DOSAGE AND ADMINISTRATION

PROSCAR may be administered with or without meals.

Monotherapy

The recommended dose of PROSCAR is one tablet (5 mg) taken once a day [see Clinical Studies ].

Combination With Alpha-Blocker

The recommended dose of PROSCAR is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies ].

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

No. 3094 — PROSCAR tablets 5 mg are blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and PROSCAR on the other. They are supplied as follows:

NDC 0006-0072-31 unit of use bottles of 30
NDC 0006-0072-58 unit of use bottles of 100.

Storage And Handling

Store at room temperatures below 30°C (86°F). Protect from light and keep container tightly closed.

Women should not handle crushed or broken PROSCAR tablets 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 [see WARNINGS AND PRECAUTIONS . Use In Specific Populations and PATIENT INFORMATION ].

Distributed by: Merck Sharp & Dohme Corp. a subsidiary of MERCK & CO. INC. Whitehouse Station, NJ 08889, USA. Revised: Sep 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/6/2016