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Propecia

"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"...

Propecia

Propecia

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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. Withdrawal of treatment leads to reversal of effect within 12 months.

HOW SUPPLIED

Dosage Forms And Strengths

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

No. 6642 — PROPECIA tablets, 1 mg, are tan, octagonal, film-coated convex tablets with “stylized P” logo on one side and PROPECIA on the other. They are supplied as follows:

NDC 0006-0071-31 bottles of 30 (with desiccant)
NDC 0006-0071-54 PROPAK® bottles of 90 (with desiccant).

Storage and Handling

Store at room temperature, 15-30°C (59-86°F). Keep container closed and protect from moisture.

Women should not handle crushed or broken PROPECIA 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. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [see WARNINGS AND PRECAUTIONS, Use in Specific Populations and PATIENT INFORMATION].

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889, USA

Last reviewed on RxList: 2/13/2014
This monograph has been modified to include the generic and brand name in many instances.

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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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