FINASTERIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)

Tillgänglig från:

Bryant Ranch Prepack

INN (International namn):

FINASTERIDE

Sammansättning:

FINASTERIDE 1 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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),

Produktsammanfattning:

Product: 71335-0235 NDC: 71335-0235-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0235-2 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0235-3 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0235-4 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0235-5 180 TABLET, FILM COATED in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

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 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).
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 ACCORD HEALTHCARE INC.
AT 1-866-941-7875 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.