Proscar (Finasteride) - Indications and Dosage

INDICATIONS AND USAGE

PROSCAR is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

-Improve symptons

-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 AUA symptom score).

DOSAGE AND ADMINISTRATION

The recommended dose is 5 mg orally once a day.

PROSCAR can be administered alone or in combination with the alpha-blocker doxazosin (see CLINICAL PHARMACOLOGY, Clinical Studies).

PROSCAR may be administered with or without meals.

No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

HOW SUPPLIED

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

NDC 0006-0072-28 unit dose packages of 100

NDC 0006-0072-82 bottles of 1000.

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, EXPOSURE OF WOMEN — RISK TO MALE FETUS, and PRECAUTIONS, Information for Patients and Pregnancy).

Distributed by:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Issued March 2007

Printed in USA

9631302