Prescribing Information on Propecia

INDICATIONS AND USAGE
PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area (see CLINICAL PHARMACOLOGY, Clinical Studies).

Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated in women (see CLINICAL PHARMACOLOGY, Clinical Studies and CONTRAINDICATIONS).

PROPECIA is not indicated in children (see PRECAUTIONS, Pediatric Use).

DOSAGE AND ADMINISTRATION
The recommended dosage is 1 mg once a day.

PROPECIA may be administered with or without meals.

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.

CONTRAINDICATIONS
PROPECIA is contraindicated in the following:

Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of 5a-reductase inhibitors to inhibit the conversion of testosterone to DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (see also WARNINGS, EXPOSURE OF WOMEN – RISK TO MALE FETUS; and PRECAUTIONS, Information for Patients and Pregnancy.) In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Hypersensitivity to any component of this medication.

HOW SUPPLIED
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 unit of use bottles of 30.

NDC 0006-0071-61 PROPAK®*** – carton of 3 unit of use bottles of 30.

***Registered trademark of MERCK & CO., Inc.

YOU CAN BE INFORMED ABOUT CLINICAL PHARMACOLOGY OF PROPECIA ON THE OFFICIAL WEBSITE OF PROPECIA
www.propecia.com