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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).
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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.
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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
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