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Proscar

"April 13, 2012 -- The baldness drug Propecia and the BPH drug Proscar may cause infertility and more sexual problems than previously thought, the FDA warns.

The main ingredient of both drugs is finasteride. Finasteride reduces male ho"...

Proscar

Proscar

INDICATIONS

Monotherapy

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

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.

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: April 2012

Last reviewed on RxList: 5/2/2012
This monograph has been modified to include the generic and brand name in many instances.

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Proscar - User Reviews

Proscar User Reviews

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Here is a collection of user reviews for the medication Proscar sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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