FINASTERIDE- 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:

Bryant Ranch Prepack

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets, USP 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, USP are not indicated for use in women. - Finasteride is contraindicated in the following: 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).

Product summary:

Finasteride Tablets, USP 1 mg are reddish brown, round biconvex, film-coated tablets, marked ‘F1’ on one side and “” on the other side. Available in bottles of 30’s (NDC 45963-600-03), 90’s (NDC 45963-600-09), and 100’s (NDC 45963-600-11).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS,
USP.
FINASTERIDE TABLETS, USP, FILM COATED FOR ORAL USE.
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Increased Risk of High-Grade Prostate Cancer
with 5α-Reductase Inhibitors (5.3) 06/2011
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).
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 ACTAVIS AT
1-800-4