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:

Avera McKennan Hospital

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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, 5 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride, is a 5α-reductase inhibitor, indicated for the treatment
of symptomatic benign prostatic hyperplasia (BPH) in
men with an enlarged prostate to (1.1):
Improve symptoms
Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and prostatectomy.
Finasteride administered in combination with the alpha-blocker
doxazosin is indicated to reduce the risk of symptomatic
progression of BPH (a confirmed ≥4 point increase in American
Urological Association (AUA) symptom score) (1.2).
LIMITATIONS OF USE: Finasteride is not approved for the prevention of
prostate cancer (1.3).
DOSAGE AND ADMINISTRATION
Finasteride may be administered with or without meals (2).
Monotherapy: One tablet (5 mg) taken once a day (2.1).
Combination with Doxazosin: One tablet (5 mg) taken once a day in
combination with the alpha-blocker doxazosin (2.2).
DOSAGE FORMS AND STRENGTHS
5-mg film-coated tablets (3).
CONTRAINDICATIONS
Hypersensitivity to any components of this product (4).
Women who are or may potentially be pregnant (4, 5.4, 8.1, 16).
WARNINGS AND PRECAUTIONS
Finasteride reduces serum prostate specific antigen (PSA) levels by
approximately 50%. However, 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 (5.1).
Finasteride may increase the risk of high-grade prostate cancer (5.2,
6.1).
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 (5.3, 8.1, 16).
Finasteride i