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:

Actavis Pharma, Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - 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 greater than or equal to 4 point increase in American Urological Association (AUA) symptom score). Finasteride is not approved for the prevention of prostate cancer. Finasteride is contraindicated in the following: - Hypersensitivity to any component of this medication. - 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 e

Product summary:

Finasteride Tablets USP, 5 mg are blue, round, biconvex film-coated tablets, with “F5” on one side and “” on the other side. Available in bottles of 30’s (NDC 45963-500-30), 90’s (NDC 45963-500-08) and 100’s (NDC 45963-500-02). Storage and Handling Store at 20 to 25ºC (68 to 77ºF) with excursions permitted between 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. 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 [see Warnings and Precautions (5.3) , Use in Specific Populations (8.1)  and Patient Counseling Information (17.2) ].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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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 symptomatic benign prostatic hyperplasia (BPH) in
men with an enlarged prostate to (1.1):
Improve symptoms
Reduce the risk of acute urinary retention
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 greater than or equal to 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 tablets 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