FINASTERIDE tablet film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Qualitest Pharmaceuticals

DCI (Denominação Comum Internacional):

FINASTERIDE

Composição:

FINASTERIDE 5 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
QUALITEST PHARMACEUTICALS
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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, USP FOR ORAL USE
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 are 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.
Finasterid tablets 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) (1.2).
LIMITATIONS OF USE: Finasteride Tablets 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 Tablets 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-grad