FINASTERIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Dr Reddys Laboratories Inc

INN (Internationale Bezeichnung):

FINASTERIDE

Zusammensetzung:

FINASTERIDE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 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 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

Produktbesonderheiten:

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 30 NDC 43598-303-30 Bottles of 90 NDC 43598-303-90 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)].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
DR REDDYS LABORATORIES 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 tablets, 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 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 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).
Women who are or may potentially be pregnant (4,5.4, 8.1, 16).
WARNINGS AND PRECAUTIONS
Finasteride tablets 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 tablets 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