PROPECIA

Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated for use in women.

PROPECIA may be administered with or without meals.

The recommended dose of PROPECIA is one tablet (1 mg) taken once daily.

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.

PROPECIA tablets (1 mg) are tan, octagonal, film-coated convex tablets with "stylized P" logo on one side and PROPECIA on the other.

PROPECIA is contraindicated in the following:

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 1500 mg/m

PROPECIA (finasteride) tablets contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).

The chemical name of finasteride is

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.

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

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:

Advise the patient to read the

Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken PROPECIA tablets 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. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken PROPECIA tablets, the contact area should be washed immediately with soap and water

Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer

Physicians should inform the patients that PROPECIA may cause symptoms of sexual dysfunction such as decreased libido, erectile dysfunction, and ejaculation disorder, including decreased ejaculate volume.

Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported

Physicians should instruct their patients to read the patient package insert before starting therapy with PROPECIA and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding PROPECIA.

NDC 78206-152-01

Each tablet contains 1 mg finasteride.