FINASTERIDE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Teva Pharmaceuticals USA, Inc.

INN (nume internaţional):

FINASTERIDE

Compoziție:

FINASTERIDE 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 ≥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 females 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

Rezumat produs:

Finasteride Tablets USP, 5 mg are available as blue, film-coated, capsule-shaped, unscored tablets, debossed “93” on one side and “7355” on the other side, in bottles of 30, 90, and 500 tablets. NDC 0093-7355-56 bottle of 30. NDC 0093-7355-98 bottle of 90. NDC 0093-7355-05 bottle of 500. Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. Females 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, USP and the subsequent potential risk to a male fetus [see Warnings and Precautions (5.3), and Use in Specific Populations (8.1)] . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, 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 ≥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).
Females who are or may potentially be pregnant (4, 5.3, 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).
Females should not handle crushed or broken finasteride tablets when
they are pregnant or may
potentially be pregnant