FINASTERIDE- finasteride tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

KAISER FOUNDATION HOSPITALS

INN (nemzetközi neve):

FINASTERIDE

Összetétel:

FINASTERIDE 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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). Finasteride tablets USP are not approved for the prevention of prostate cancer. Finasteride tablets USP 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 abnormalities of the external genitalia of a

Termék összefoglaló:

Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other side. They are supplied as follows:    Bottles of 2160 NDC 0179-0175-88 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed. Women should not handle crushed or broken finasteride tablets USP 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)].

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FINASTERIDE- FINASTERIDE TABLET
KAISER FOUNDATION HOSPITALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINASTERIDE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINASTERIDE TABLETS
USP.
FINASTERIDE TABLETS USP
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.3) 06/2011
Warnings and Precautions, Increased Risk of High-Grade Prostate Cancer
(5.2) 06/2011
INDICATIONS AND USAGE
Finasteride tablets USP, 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 is not approved for the
prevention of prostate cancer (1.3).
DOSAGE AND ADMINISTRATION
Finasteride tablets USP 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 tablets USP reduces serum prostate specific antigen (PSA)
levels by approximately 50%. However, any
confirmed increase in PSA while on finasteride tablets USP 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 USP may i