FINASTERIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Finasteride (UNII: 57GNO57U7G) (Finasteride - UNII:57GNO57U7G)

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

Finasteride

Composition:

Finasteride 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY .   Efficacy in bitemporal recession has not been established.   Finasteride tablets are not indicated for use in women. Finasteride is contraindicated in the following: - Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See Warnings and Precautions (5.1), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.1) .] In female rats, low doses of finasteride administered dur

Product summary:

Finasteride tablets USP, 1 mg are beige, round, film-coated tablets embossed with “R” on one side and “171” on the other side and are supplied in bottles of 30’s, 90’s,180’s and 500’s. Bottles of 30                                                               NDC 55111-171-30 Bottles of 90                                                               NDC 55111-171-90 Bottles of 180                                                             NDC 55111-171-18 Bottles of 500                                                             NDC 55111-171-05 Storage and Handling Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. 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 [see Warnings and Precautions (5.1), Use in Specific Populations (8.1) and Patient Counseling Information (17.1) ].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
DR. REDDY'S LABORATORIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FINASTERIDE.
FINASTERIDE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride tablet 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).
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 DR. REDDY’S
LABORATORIES INC. AT 1-888-375-3784 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING