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:

Unit Dose Services

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
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE TABLETS 5 MG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS
5 MG. FINASTERIDE TABLETS USP, 5 MG,
FOR ORAL USE INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Finasteride tablets 5 mgare 5α-reductase inhibitors, 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 tablets 5 mgadministered 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) ( ). : Finasteride tablets 5 mg are not approved for the
prevention of prostate cancer ( ). 1.2
LIMITATIONS OF USE1.3
DOSAGE AND ADMINISTRATION
Finasteride tablets 5 mg may be administered with or without meals (
). Monotherapy: One tablet (5 mg) taken once a day (
). Combination with Doxazosin: One tablet (5 mg) taken once a day in
combination with the alpha-blocker doxazosin ( ). 2
2.1
2.2
DOSAGE FORMS AND STRENGTHS
5 mg film-coated tablets ( ). 3
CONTRAINDICATIONS
Hypersensitivity to any components of this product ( ). Women who are
or may potentially be pregnant ( , , , ). 4
45.48.116
WARNINGS AND PRECAUTIONS
Finasteride tablets 5 mg reduce serum prostate specific antigen (PSA)
levels by approximately 50%. However, any
confirmed increase in PSA while on finasteride tablets 5 mg 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 tablets 5 mg may increase the risk of high-grade prostate
cancer ( , ). 5.26.1
Women should not handle crushed or broken finasteri