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:

NuCare Pharmaceuticals,Inc.

INN (International Name):

FINASTERIDE

Composition:

FINASTERIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finasteride tablets, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets, USP are administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). Finasteride tablets, USP are not approved for the prevention of prostate cancer. Finasteride tablets are 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 abnormal

Product summary:

Finasteride Tablets USP, 5 mg are blue colored, circular, biconvex, beveled edged film-coated tablets debossed with E on one side and 61 on the other side. NDC 68071-3234-9 Bottles of 90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and 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
NUCARE PHARMACEUTICALS,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 the need for surgery including transurethral
resection of the prostate (TURP) and
prostatectomy.
Finasteride tablets, USP 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 tablets, USP are 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 pregnant due to potential risk