FINASTERIDE- 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:

Mylan Institutional Inc.

DCI (Denominação Comum Internacional):

FINASTERIDE

Composição:

FINASTERIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride 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). Finasteride tablets 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 abnormalities of the external genitalia of a male fetus of a pr

Resumo do produto:

Finasteride Tablets, USP are available containing 5 mg of finasteride, USP. The 5 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and 151 on the other side. They are available as follows: NDC 51079-321-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-321-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Patient Information Leaflet with each prescription. 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)].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
MYLAN INSTITUTIONAL 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, USP 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 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 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 ri