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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 ).
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.
Warnings
PROPECIA is not indicated for use in pediatric patients ( see
INDICATIONS AND USAGE; and PRECAUTIONS, Pediatric Use )
or women ( see also PRECAUTIONS, Information for Patients
and Pregnancy; and HOW SUPPLIED, Storage and
Handling ).
EXPOSURE OF WOMEN - RISK TO MALE FETUS
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 have not been broken
or crushed. ( See also CONTRAINDICATIONS; PRECAUTIONS, Information
for Patients and Pregnancy; and HOW SUPPLIED,
Storage and Handling. )
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