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 orally 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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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 (with desiccant)
NDC 0006-0071-61 PROPAK® - carton of 3 unit of use bottles of 30 (with desiccant)
NDC 0006-0071-54 PROPAK unit of use bottle 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, EXPOSURE OF WOMEN - RISK TO MALE FETUS; and PRECAUTIONS, Information for Patients and Pregnancy.)
Distributed by:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Issued May 2007
9636003
US Patent No.: 5,547,957
US Patent No.: 5,571,817
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