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.
In clinical studies, single doses of finasteride up to 400 mg
and multiple doses of finasteride up to 80 mg/day for
three months did not result in adverse reactions. Until
further experience is obtained, no specific treatment for
an overdose with finasteride can be recommended.
Significant lethality was observed in male and female mice
at single oral doses of 1,500 mg/m2 ( 500 mg/kg
) and in female and male rats at single oral doses of 2,360 mg/m2
( 400 mg/kg ) and 5,900 mg/m2 ( 1,000 mg/kg
), respectively.
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.
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, EXPOSURE OF WOMEN - RISK
TO MALE FETUS; and PRECAUTIONS, Information for Patients
and Pregnancy. )
***Registered trademark of MERCK & CO., Inc.
