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:

AvPAK

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 t

Rezumat produs:

Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other sideon other side. They are supplied as follows: NDC 50268-314-15 (10 tablets per card, 5 cards per carton). Storage and Handling Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed. If dispensed, protect from light and keep in tightly closed container. 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)].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FINASTERIDE- FINASTERIDE TABLET, FILM COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FINASTERIDE TABLETS USP
RX ONLY
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, 5 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
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 increase the risk of high-grade
prostate cancer (5.2, 6.1).
• Women should not handle crushed or broken f