Finasteride 1 mg Tablets — Generic For Propecia — Aurobindo

These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS.

FINASTERIDE tablets, for oral use

Initial U.S. Approval: 1992

Indications And Usage

Finasteride is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY(1).

Finasteride tablets are not indicated for use in women (1, 4, 5.1).

Dosage And Administration

Finasteride tablets may be administered with or without meals (2).

One tablet (1 mg) taken once daily (2).

In general, daily use for three months or more is necessary before benefit is observed (2).

Dosage Forms And Strengths

1 mg tablets (3).

Contraindications

Pregnancy (4, 5.1, 8.1, 16).

Hypersensitivity to any components of this product (4).

Warnings And Precautions

• Finasteride is not indicated for use in women or pediatric patients (5.1, 5.4).
• Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.1, 8.1, 16).
• Finasteride causes a decrease in serum PSA levels. Any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.2).
• 5α-reductase inhibitors may increase the risk of high-grade prostate cancer (5.3, 6.1).

• Finasteride is not indicated for use in women or pediatric patients (5.1, 5.4).
• Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.1, 8.1, 16).
• Finasteride causes a decrease in serum PSA levels. Any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.2).
• 5α-reductase inhibitors may increase the risk of high-grade prostate cancer (5.3, 6.1).

Finasteride is not indicated for use in women or pediatric patients (5.1, 5.4).

Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus (5.1, 8.1, 16).

Finasteride causes a decrease in serum PSA levels. Any confirmed increase in PSA while on finasteride may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor (5.2).

5α-reductase inhibitors may increase the risk of high-grade prostate cancer (5.3, 6.1).

Adverse Reactions

The most common adverse reactions, reported in ≥1% of patients treated with finasteride and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2022