Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into 5a-dihydrotestosterone (DHT).

Finasteride is 4-azaandrost-1-ene-17-carboxamide,N-(1,1-dimethylethyl)-3-oxo-,(5a,17b)-. The empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.

Finasteride tablets for oral administration are film-coated tablets that contain 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, hydroxypropyl methylcellulose 2910, hydroxypropyl cellulose, titanium dioxide, talc, yellow ferric oxide, and red ferric oxide.

INDICATIONS

Finasteride 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.

Finasteride is not indicated in women

DOASAGE AND ADMINISTRATION

The recommended dosage is 1 mg once a day.

Finasteride 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. Withdrawal of treatment leads to reversal of effect within 12
HOW SUPPLIED

No. 6550 — finasteride tablets, 1 mg, are tan, octagonal, film-coated convex tablets with code MRK 71 on one side and finasteride 1 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 finasteride 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. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

PATIENT INFORMATION

Women should not handle crushed or broken finasteride 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. finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

WARNINGS

Finasteride is not indicated for use in pediatric patients or women.